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2nd Edition
Edited by
Paul B. Pynsent
Research and Teaching Centre, Royal Orthopaedic Hospital,
Birmingham, UK
Andrew J. Carr
University of Oxford, Nuffield Orthopaedic Centre, Oxford, UK
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Contents
Contributors vii
Preface xi
Acknowledgements xv
1 Choosing an outcome measure 1
Paul B. Pynsent
2 A systematic approach to developing comparative health outcome indicators 8
Alastair Mason, Andrew Garratt, Edel Daly and Michael J. Goldacre
3 Economic evaluation 18
Nikos Maniadakis and Alastair Gray
4 Randomized controlled trials 31
Jeremy C. T. Fairbank
5 Register studies 41
Leif I. Havelin, Birgitte Espehaug, Ove Furnes, Lars B. Engester,
Stein A. Lie and Stein E. Vollset
6 Measures of health status, health-related quality of life and patient satisfaction 54
Raymond Fitzpatrick
7 The measures of pain 63
Henry J. McQuay
8 Trauma severity indices 70
Julian P. Cooper
9 Complications 81
Alasdair J. A. Santini and Simon P. Frostick
10 Outcome after blast, missile and gunshot wounds 95
Jonathan C. Clasper
11 Deformity and cosmesis 105
T. N. Theologis
12 Growth plate injuries 113
D. M. Eastwood
13 Peripheral nerve injuries 127
David Warwick and Peter P. Belward
04098-prelims.qxd 07/02/2004 17:38 PM Page vi
vi Contents
Contributors
Jonathan C. Clasper, DPhil, DM FIMC FRCSEd (Orth) Jeremy C. T. Fairbank, MD, FRCS
DMCC Consultant Orthopaedic Surgeon, Nuffield
Consultant Orthopaedic Surgeon, Orthopaedic Centre, Oxford, UK
Frimley Park Hospital, Surrey, UK
Julian P. Cooper, BSc, FRCS (Tr & Orth) Raymond Fitzpatrick, BA, MSc, PhD
Consultant Orthopaedic Trauma Surgeon, Professor of Public Health and Primary Care,
South Birmingham Trauma Unit, Department of Public Health, University of
Selly Oak Hospital, University Hospital Oxford, Institute of Health Sciences,
Birmingham NHS Trust, Birmingham, UK Oxford, UK
viii Contributors
Ove Furnes, MD, PhD and Primary Health Care, University of Bergen,
Orthopaedic Surgeon and Head of the Bergen, Norway
Norwegian Arthroplasty Register, Department of
Nikos Maniadakis, PhD, MSc
Orthopaedic Surgery, Haukeland University
General Manager, General University Hospital of
Hospital, Bergen, Norway
Patras, Rion Patras, Greece
Andrew Garratt, BA, MSc, PhD
David R. Marsh, MD, FRCS
Research Lecturer, Unit of Health Care
Professor of Trauma and Orthopaedics,
Epidemiology, Department of Public Health,
Queens University, Belfast
Oxford University, Oxford, UK
Musculoskeletal Education and Research Unit,
Michael J. Goldacre, BM, BCh, FFPHM Musgrave Park Hospital, Belfast, UK
Professor of Public Health, Unit of Health Care
Epidemiology, Department of Public Health, Oxford Alastair Mason, FRCP, FFPHM
Epidemiologist, Cobblers Close, Gotherington, UK
University, Oxford, UK
Raman V. Kalyan, D Ortho, Dip N B Ortho Surg Alasdair J. A. Santini, FRCS (Orth)
Spine Fellow, Department of Trauma and Royal Liverpool Hospital, Liverpool, UK
Orthopaedics Surgery, Queens University of
Michael M. Stephens, MSc (Bioeng), FRCSI
Belfast, Musgrave Park Hospital, Belfast, UK
Consultant Orthopaedic Surgeon, Cappagh
Stein A. Lie, PhD, MSc National Orthopaedic, Mater Misericordae and
Research Fellow, Section for Epidemiology and University Childrens Hospitals,
Medical Statistics, Department of Public Health Dublin, Ireland
04098-prelims.qxd 07/02/2004 17:38 PM Page ix
Contributors ix
T. N. Theologis, FRCS David Warwick, MD, BM, DIME, FRCS, FRCS (Orth)
Consultant Orthopaedic Surgeon, Nuffield Consultant Hand Surgeon, Southampton
Orthopaedic Centre, Oxford, UK University Hospitals, Southampton, UK
Preface
Outcome is defined by The Oxford English Dic- relationship to any intervention, social or
tionary as a visible or practical result. Outcome environmental circumstance is understood.
measures play an important rle in medical practice. An example is infant mortality rate.
They should provide the basis for both clinical audit
and research. The principal object of this book is An Outcome Measurement is a sub-type of
health status measurement where changes in
to provide references to sources of instruments
the measure are known (or at least believed) to
and techniques used for outcome measurement in
be largely attributable to a health service
orthopaedics and trauma and to advise on the opti-
intervention. An example, in the field of
mum choice of instrument. It will become clear to
paediatrics is life expectancy for people with
any student of this topic that it is not an easy subject
cystic fibrosis.
and there remain many areas without adequate out-
come measures. An Implied Outcome Measurement is an
The text is aimed at medical staff in orthopaedic indirect indicator of health that can be used as
units, trauma centres and accident and emergency a valid proxy for an outcome measurement.
departments. The book may also be of value to Examples are immunization coverage, and
physiotherapists, metrologists, research nurses and coverage of a screening programme of proven
others involved in clinical research into orthopaedics effectiveness. In our view, the health status
and trauma. There is a medico-legal dimension to measurement may also be described as
this topic. Outcome measures are vital to the setting functional status measurement and a quality
of standards of care and their measurement, as well of life measure. These measurements can be
as in the assessment of disease or injury severity. made without necessarily seeking improvement.
This is of relevance to both lawyers and clinicians
The Editors of this book have all had a longstand-
in this area, who will find in this book a reference
ing interest in outcome measures. Each has con-
to the most appropriate outcome measures for their
tributed both to the original development of outcome
purpose. The setting of standards of care and the
instruments and to studies to establish their validity,
assessment of the quality of care is also of concern
reliability and responsiveness. We have collaborated
to doctors in public health medicine, purchasers
to produce collections of outcome measures for
and government. It is important for the clinician to
orthopaedics (Pynsent et al. 1993) and for trauma
maintain an interest in this field, not least to ensure
(Pynsent et al. 1994) in separate texts, and also in a
that managers are receiving accurate and relevant
text on methodology (Pynsent et al. 1997). We have
clinical information about his or her activities.
also collected classification systems in trauma
The British Paediatric Association Outcome
(Pynsent et al. 1999).
Measures Working Group (British Paediatric Asso-
In this book, we have combined orthopaedic and
ciation 1992) has presented a number of definitions:
trauma outcome measures in a single volume. In our
A Health Status Measurement is a direct original texts we used a conference based on the
measure of some aspect of health in which Dahlem model to review draft chapters (Dixon
improvement is sought, whether or not its 1987) but on this occasion we have asked authors
04098-prelims.qxd 07/02/2004 17:38 PM Page xii
xii Preface
to collect, classify and where possible to tabu- been included in the summary table, but with an
late outcome measures. We also asked them to rank asterisk beside it and comments in the chapter text.
outcome measures according to a formula laid out These papers have not been added into the score.
below. This has not always been achieved but we In the event of a score tie, then if one is self-reporting
believe that the results will be of value to both clin- (i.e. completed by the patient) then it wins. If they
ical research and audit. There may be some circum- are both self-reporting then the one with the fewest
stances where instruments can be used to evaluate questions wins otherwise it is a tie.
individual patients as an aid to clinical assessment In general, many of the outcome measures in clin-
and decision making. ical practice are based on scoring systems, though
most of these systems are poorly validated. New-
comers to the field will experience difficulties not
OUTCOME INSTRUMENTS only in finding the available instruments but also in
making an informed choice as to the most appro-
Where possible, instruments (questionnaires or priate for their purpose. This book is designed to
other outcome systems) have been either actually help in making such a choice. We have tried to be
included as an appendix or carefully referenced. descriptive as well as proscriptive. Often, there are
A summary of instruments (questionnaires or other differences between the requirements of outcome
outcome systems) has been tabulated in Table 1. measures for audit as opposed to clinical research.
In most cases there is a pay-off between the demands
of speed, efficiency and acceptability to both doctor
SCORING OUTCOME and patient and the demands of precision and
INSTRUMENTS specificity. In our opinion, some instruments are so
complex that they have become impossible to
Instruments have been scored according to Table 2. use. Where possible, it should be indicated where
Where a paper has been published showing poor apparently clear-cut measures of outcome (for
validity, reliability or responsiveness results, it has example, the union of a fractured tibia) may be
Table 1
Table 2
Validated 0 1 2
Reliability tested 0 1 2
Responsiveness tested 0 1 2
Usage published 0 Scores from 1 for each publication, to a maximum of 4
This should exclude any publications that have scored in the three previous categories.
04098-prelims.qxd 07/02/2004 17:38 PM Page xiii
Preface xiii
vulnerable to confounding factors, such as clinical impairment, disability and handicap of considerable
judgement, age or intercurrent illness. An instrument value. Impairment is a demonstrable anatomical loss
should be quick, simple to use, reliable, specific to or damage, such as the loss of range of movement of
the question being investigated, cost-effective, and a joint. Disability is the functional limitation caused
applicable. In most cases this ideal instrument does by an impairment, which interferes with something a
not exist, although many measures have come into patient wishes to or must achieve. Handicap depends
general use without meeting these criteria. on the environment. For example, a patient confined
In this book we have tried to indicate areas where to a wheelchair may be fully mobile on the level, yet
there are deficiencies in the currently available instru- be completely immobilized by a flight of stairs.
ments and these may represent avenues for future The measurement of complications is not, strictly
research. We would expect that the pragmatic reader speaking, an outcome measure. However, complica-
should be content with the best available instrument tions are commonly the major component of review
but, if dissatisfied, an innovator should be stimulated in clinical audit, as it is currently practised in the UK.
to develop new systems for the future. Streiner and They may be of importance in clinical trials and are
Norman (2003) provide invaluable advice on how routinely reported in most retrospective reviews of a
this may be achieved. An area that has not been condition and its treatment.
addressed is the question of who should carry out the
measurements in research. It is sometimes possible to
have a research nurse or an independent observer to REFERENCES
fulfil this important task but in practice it is usually
the surgeon who is obliged to perform the measure- British Paediatric Association (1992): Outcome
ments. Whoever performs this task will introduce Measurements for Child Health. British
their own biases. A North American view on general Paediatric Association, London.
outcome measures can be found in Spilker (1990) but Dixon, B. (1987): Scientifically speaking. Br Med J
these should be only used in the United Kingdom 294, 1424.
with some circumspection. Pynsent, P. B., Fairbank, J. C. T., and Carr, A. J. (1993):
Outcome measures may be broadly distinguished Outcome Measures in Orthopaedics.
into those used to measure the doctors assessment, Butterworth-Heinemann, Oxford.
and those used to measure the patients own assess- Pynsent, P. B., Fairbank, J. C. T., and Carr, A. J. (1994):
ment of their problem. In most cases it is appropri- Outcome Measures in Trauma. Butterworth-
ate to record both types of outcome. The latter are Heinemann, Oxford.
widely used by health economists, managers and Pynsent, P. B., Fairbank, J. C. T., and Carr, A. J. (1997):
politicians. As these two approaches are likely to be Assessment Methodologies in Orthopaedics.
measuring different factors, it is our opinion that Butterworth-Heinemann, Oxford.
they should normally be presented as separate out- Pynsent, P. B., Fairbank, J. C. T., and Carr, A. J. (1999):
comes. The problems and advantages of these two Classification of Musculoskeletal Trauma.
groups of measurement should be addressed in the Butterworth-Heinemann, Oxford.
text. The more we have investigated this field, the Spilker, B. (1990): Quality of Life Assessments
more we have become convinced of the value of in Clinical Trials. Raven Press, New York.
patient-based measures. In the past, these have been Streiner, D. L., and Norman, G. R. (2003): Health
dismissed as being too unreliable for serious con- Measurement Scales: A practical guide to their
sideration by clinical investigators but, in fact, development and use. 3rd edition. Oxford
these assessments tend to follow closely the main Medical Publications, Oxford.
indication for the original intervention. World Health Organization (1986): International
We have found the World Health Organizations Classification of Impairments, Disabilities and
(World Health Organization 1986) definitions of Handicaps. World Health Organization, Geneva.
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04098-prelims.qxd 07/02/2004 17:38 PM Page xv
Acknowledgements
The editors are indebted to Ann Weaver at the We should also like to thank Zelah Pengilley, the
Research and Teaching Centre, The Royal Ortho- publishers Project Editor, for her unerring support.
paedic Hospital for help in preparation of the manu- We are most grateful to Bill Down, the copy-editor,
scripts including reorganizing all the references for and Marian Haimes, the proof-reader, for their
our reference-management software. In addition her meticulous work.
help with the proof corrections was invaluable.
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04098-01.qxd 06/02/2004 14:26 PM Page 1
1
Choosing an outcome measure
Paul B. Pynsent
A shortened version of this chapter first appeared in the Journal of Bone and Joint Surgery: Pynsent, P. B. (2001): Choosing an outcome
measure. J Bone Joint Surg 83-B, 7924.
04098-01.qxd 06/02/2004 14:26 PM Page 2
(a) Unreliable and invalid (b) Reliable but invalid (c) Unreliable but valid (d) Reliable and valid
Figure 1.1 A target analogy for reliability and validity. The 'bull's eye' represents the true outcome to be measured, and each arrow
represents a single application of the outcome instrument.
Validity 3
Written questionnaires will usually be constructed
INSTRUMENT CONTENT from simple binary (yes/no) and graded questions.
The items measured for outcome may be based on The graded or scaled questions are normally based
signs, symptoms, complications and investigations. on visual analogue scales (VASs), Likert scales or
Any of these items may be intermixed, for example some form of adjectival question. The advantages
the Harris Hip Score (Harris 1969) uses both symp- and disadvantages of these are discussed at length
toms and signs to produce a final score. The resultant by Streiner and Norman (1995; see Chapter 4).
measure is reported either as a statistic, values or cat- Guyatt et al. (1987) compared Likert scales to VASs
egories for each dimension measured or an overall and showed no difference in their sensitivities to
score (also termed an index). change, although patients found VAS questions more
After establishing that the validity and reliability difficult to understand. In the present authors
have been demonstrated, the choice of an instrument own experience, VASs confuse patients and delude
should be a measure that is practical to implement. surgeons into believing that they have continuous
Measures that comprise solely self-reported symp- data. Redundant items should not be included in
toms are much easier to use than those requiring a an instrument. Redundancy may not always be
clinical component such as X-ray, operative or range obvious two items may ask the same question in a
of movement data. The inclusion of such data should different way, or an item may be asking a question
be carefully weighed against ease of implementation about a different trait from that being measured.
and the concomitant compliance both of the user This heterogeneity may be identified by correlating
and colleagues. Incomplete data collection renders the questions of an instrument with each other. There
useless results. are various ways of doing this, but Cronbachs
In the past, the belief was that the patients view (Cronbach 1951) is the most generally applicable.
was of no value in measurement. Thus, the so-called Results for homogeneity should have been published
subjective tests were dismissed in favour of objec- for an instrument, and should lie between 0.7
tive data. (In this context, subjective means per- and 0.9.
taining to a perceived condition within the patients Good content will produce a reliable and valid
own consciousness, objective is a condition of the instrument.
mind or body as perceived by another.) In fact, it is
now clear that well-designed self-reported question-
naires are very good at determining health traits. VALIDITY
Furthermore, many clinical signs have never been
tested for reliability. It might come as a surprise that Unfortunately, there is no one statistic that will tell
the physicians icon the stethoscope is unreliable, the reader the validity of an instrument. Any pub-
even in the hands of a specialist chest physician (Spiteri lished inferential statistics about a measure may add
et al. 1988). Range of motion features in many validity to that measure. Validation has two aspects.
scoring systems (e.g. the Harris Hip Score (Harris First, have results of content and criterion or con-
1969), Constant Shoulder Assessment (Constant struct validity been published? Second and more
and Murley 1987)), even though both inter- and importantly do the published results using the
intra-rater reliability are very low (ODoherty 1997). instrument confirm that it does allow inferences to
These points should encourage the reader to follow be made about the trait it purports to measure?
the route of self-reported questionnaires when this is Content validity examines the ability of the instru-
possible. It is also worth noting that when the instru- ment to measure all aspects of the condition for which
ment is available in computerized form (Pynsent it was designed so that it is applicable to all patients
and Fairbank 1989; Hanna et al. 1999), data can with that condition. One problem with increasing
be entered directly into a database. the content is that the reliability tends to decrease;
04098-01.qxd 06/02/2004 14:26 PM Page 4
Summary 5
agreement but also adjusts for the chance agree- property for example, if death or peri-operative
ment. For ordinate data kappa has been extended complications are used as a outcome. However, in
to a weighted kappa where the amount of disagree- many situations a measure is required that is sensitive
ment is weighted. If the correct weighting is applied, to changes that occur over time due to the natural
then the weighted kappa statistic and indeed kappa history of the condition or medical intervention. The
itself can be compared directly to an ICC value. major issue here is to ensure that the instrument
Lee et al. (1989) suggest three measures of the can detect a clinically important change, even if this
agreement between two methods for these methods is quite small. This latter point has two implica-
to be interchangeable: tions. First, that a clinically important change can
be defined; the present authors experience is that
1. The lower limit of the 95 per cent confidence
many outcome measures are in use today without the
interval for the ICC should be 0.75.
users having any idea of what is the smallest clinic-
2. There should be no systematic bias. ally important change. Second, this change must be
considered when designing an experiment so that
3. The two means should not be statistically
power calculations are made accordingly; clearly, if
significantly different.
a small change must be detected and the instrument
is only moderately reliable, then large numbers of
patients would be required. The effect size is usu-
Diagnostic tests ally quoted as a measure of sensitivity to change for
instruments whose sample means are reasonably
If the instrument is being assessed for its reliability normally distributed:
as a clinical test, then sensitivity, specificity should
be used. These are derived from the proportions of Mean at time 1 Mean at time 2
a 2 2 table. The reader unfamiliar with these terms Effect size index
SD at time 1
is referred to any standard medical statistics book
(e.g. Armitage and Berry 1987). This is a commonly used definition (Kazis et al.
1989), although the assumption is that the SDs of
both samples are the same. This index is dimension-
Test-retest less, and its value gives the number of SDs apart of
the two means. Cohen (1977) mentions values of
The idea here is to apply an instrument, to re-apply it 0.2, 0.5 and 0.8 as small, medium and large effect
after a short time (5 to 14 days), and then to compare sizes, respectively. Thus, for two normal curves,
the results for agreement using an ICC or kappa. at an effect size of 0.2, only 14.7 per cent of their
However, as pointed out by Kramer and Feinstein areas will not overlap, whereas at 0.8 some 47.4 per
(1981), there is often learning bias in the retest, and cent of the curves areas will not overlap (Cohen
there are also situations where retesting is not 1977; pp. 247). Cohen also considers definitions
possible. These authors suggest methods that use for proportions and nominal variables. The situation
inter-item correlations such as Cronbachs to be for ordinal data is more difficult, and requires con-
a good measure of test-retest reliability. version to binary data or transforming and using the
definitions for continuous data.
SENSITIVITY TO CHANGE
SUMMARY
This section deals with the ability of an instrument
to detect changes with time; this is also termed The aim of this chapter has been to draw the readers
responsiveness. Some measures may not need this attention to the methodology required to establish
04098-01.qxd 06/02/2004 14:26 PM Page 6
References 7
Morrissy, R. T., Goldsmith, G. S., Hall, E. C., Kehl, D., Streiner, D. L., and Norman, G. R. (1995): Health
and Cowie, G. H. (1990): Measurement of the Measurement Scales. A practical guide to their
Cobb Angle on radiographs of patients who have development and use. Oxford University Press,
scoliosis: evaluation of intrinsic error. J Bone New York.
Joint Surg 72-A, 3207. Tarlov, A. R., Ware, J. E., Greenfield, S., Nelson, E. C.,
ODoherty, D. P. (1997): Measuring joint range of Perrin, E., and Zubkoff, M. (1989): The Medical
motion and laxity. In: Pynsent, P.B., Outcomes Study: an application of methods for
Fairbank, J. C. T., and Carr, A. J. (eds), Ortho- monitoring the results of medical care. JAMA
paedic Methodology. Heinemann-Butterworth, 262, 92530.
Oxford, pp. 12030. Theologis, T. N., and Fairbank, J. C. T. (1997):
Oldham, P. D. (1968): Measurement in Medicine. Deformity and cosmesis of the spine. In:
English Universities Press, London. Pynsent, P. B., Fairbank, J. C. T., and Carr, A. J.
Pynsent, P. B. (2001): Choosing an outcome measure. (eds), Orthopaedic Methodology. Heinemann-
J Bone Joint Surg 83-B, 7924. Butterworth, Oxford, pp. 199214.
Pynsent, P. B., and Fairbank, J. C. T. (1989): A com- Ware, J. E. (1993): Measuring patients views: the
puter interview system for patients with back optimum outcome measure. SF-36: a valid,
pain. J Biomed Eng 11, 259. reliable assessment of health from the patients
Spiteri, M. A., Cook, D. G., and Clarke, S. W. point of view. Br Med J 306, 142930.
(1988): Reliability of eliciting physical signs Wright, J. G., and Feinstein, A. R. (1992): Improving
in examination of the chest. Lancet ii, the reliability of orthopaedic measurements.
8735. J Bone Joint Surg 74-B, 28791.
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2
A systematic approach to developing comparative
health outcome indicators
Alastair Mason, Andrew Garratt, Edel Daly and Michael J. Goldacre
COMPARATIVE HEALTH Table 2.1: Factors that could be used as health outcomes
OUTCOME INDICATORS
Environmental factors in the general population such
Although interest has been expressed in using as air pollution
comparative health outcomes in management of the Environmental factors relating to the individual such
health service for some years, it is only during the as smoking
past decade that a systematic national approach to Knowledge, attitudes, behaviour in the general or
their development has taken place (Department of specific populations
Health 1993, 2001; McColl and Gulliford, 1993; Patients symptoms, function, health status and
Public Health Development Unit NHS Executive well-being
1998; NHS Executive 1999a, b). In this chapter, we Patients clinical state
focus on a project which was commissioned by the
Patients pathological and physiological state
Department of Health in the late 1990s in order to
Events occurring to patients such as:
develop ideal indicators of health outcome for ten
1. end-points of earlier occurrence of disease
clinical conditions, one of which was fractured pro-
ximal femur (Fairbank et al. 1999). 2. interventions such as GP contact, admission, death
Health outcomes can be defined as changes in
health, health-related status or risk factors affecting
health, or lack of change when change is expected.
Such a broad definition may include data about all Indicators may be derived from a number of
the factors shown in Table 2.1. In the national data sources. Data about environmental factors are
work, an indicator has been defined as an aggregated obtained from population surveys. Patients are the
statistical measure describing a group of patients source for knowledge, attitudes, health status and
or a whole population, compiled from measures or other related factors, and the data may be obtained
assessments made on the people concerned. either opportunistically or collected in a planned
Throughout the development work it has been survey. Clinical information is recorded by health
emphasized that indicators do not necessarily professionals and events data are available from
provide answers as to whether care is good or bad administrative systems.
or better in one place than another. Well-chosen Indicators may be used for a variety of purposes.
indicators will provide pointers to circumstances Clinicians have for many years compiled indicators
that may be worth further investigation; no more, for audit and research purposes and, more recently,
despite politicians current enthusiasm for league national comparable audits have been organized
tables. for conditions such as stroke (Rudd et al. 1999).
04098-02.qxd 06/02/2004 14:26 PM Page 9
Systematic Approach 9
Those involved in the strategic and operational Table 2.2: Factors considered in developing candidate
indicator list
development of health services have always required
comparative indicators to inform their decision
making. Reduce risk of fracture
However, uses are now dominating the drive to prevent accidents, particularly in elderly persons
develop health outcome indicators. The performance prevent osteoporosis
assessment framework (NHS Executive 1999b) con- Reduce risk of death
tains a range of health outcome indicators for com-
effective operation
paring both health authorities and NHS trusts.
Reduce risk of complications (types of complication)
Associated with this, policy documents such as Our
Healthier Nation (Secretary of State for Health 1998) general (pneumonia, pressure sores, pulmonary
contain outcome targets, derived from the research embolism)
literature or set by political decisions. Third, the intra-capsular (reoperation with arthroplasty,
Department of Health is now promoting the develop- mechanical failure of fixation)
ment of national standards of quality and promoting extra-capsular (failure of fixation, reoperation with
the development of clinical governance (Department device extraction)
of Health 2000). Fourth, professionals are increas- Reduce risk of complications (specific interventions)
ingly in the vanguard of innovation in quality assess- thromboprophylaxis
ment and audit.
reduction in delay before operation
Restore function and well-being
multidisciplinary rehabilitation
SYSTEMATIC APPROACH
In the work on fractured proximal femur commis-
sioned by the Department of Health, ideal indicators out literature reviews to assist the working groups
were defined as to what should be known, and what deliberations.
realistically could be known, about the condition The development of a comprehensive health out-
being addressed. Thus, the work was not constrained come model was crucial to the success of the system-
by existing data sets and could take into account atic approach. The main aims of intervention were
known information developments such as the intro- identified and under each of these headings factors
duction of the new NHS number. that might be considered for the candidate indica-
The overall aim was to recommend a comprehen- tor list were identified. Those relevant to fractured
sive menu of indicators with a standard approach proximal femur are shown in Table 2.2.
taken for all the conditions addressed. The work In working up the list of candidate indicators it
was overseen for each condition by a broadly based was considered important to include indicators with
multidisciplinary working group that included clin- different characteristics. The four factors taken into
icians, managers and representatives of patients account were measurement perspective, specificity,
and research interests. timeframe, and outcome relationship.
The initial task was to choose a list of candidate Measurement perspective was classified as being
indicators measures that were considered worthy from the patients, the clinicians or population view-
of being worked up in detail. To do this, a number of point. Thus, for fractured proximal femur a measure
checklists were developed including a comprehensive of quality of life might be more appropriate from
health model. Researchers from the NHS Centre the patients perspective, while clinicians may be
for Reviews and Dissemination at the University of more concerned about post-operative complications.
York and the Clearing House on Health Outcomes The population perspective includes measures such
at the University of Leeds were also available to carry as mortality rates.
04098-02.qxd 06/02/2004 14:26 PM Page 10
using comparative mortality, admission, case fatality Two of the indicators, potentially available from
and re-admission rates. routine systems, require coding of the side on which
The implementation recommendations for the the operation was done. The hospitalized incidence
indicators made by the working group have been of a second fracture (indicator 1B) was suggested in
reviewed in the light of this further work, and in some order to obtain a measure of the success of prevent-
cases they have been revised to take into account this ive measures in the group at high risk having had
additional information. an initial fracture. The rate of ipsilateral hip surgery
within 120 days of discharge (indicator 8) would
have been a good measure of complications follow-
CANDIDATE INDICATORS ing initial surgery.
NOT YET GENERALLY Although codes exist for recording whether the
IMPLEMENTABLE operation was on the left or right hip, these are too
poorly completed to recommend now for routine
Seven of the 16 candidate indicators are not yet gen- implementation of these indicators. They both also
erally implementable, and these are shown in italic require the linkage of separate hospital episodes.
text in Table 2.3. However, it would be possible to mount special
04098-02.qxd 06/02/2004 14:26 PM Page 12
Four of the candidate indicators can be derived from emergency or all re-admissions
routine systems now that the NHS number has been diagnostic coding, condition-specific or all causes
implemented. Two of them (indicators 1A and 3) time interval from end of initial admission and
can be used to compare populations, and two (indi- start of re-admission
cators 4 and 9) to compare hospitals or NHS trusts. General points (all indicators)
Extensive work has been carried out by NCHOD age/sex and other standardization
since the publication of the Report to determine the
statistical power, adequate numbers to show
best ways of compiling these indicators and to refine differences
the definitions included in the indicator specifica-
accuracy and completeness of data
tions. The main issues that have been addressed are
shown in Table 2.5. methodology used for linking records and its
accuracy
The definition of an admission is crucial to all
admission-based indicators. The admission forms the
numerator for the calculation of admission rates and
also the denominator for the calculation of adverse from admission to discharge from hospital and this,
event rates following admission. Routine NHS stat- rather than the consultant episode, is generally the
istics are currently based on the building block right measure for these indicators.
of finished consultant episodes (the time a patient A trickier issue arises when a patient has more
spends in the care of each consultant). If a patient is than one admission for fractured proximal femur.
transferred between consultants within the hospital The admissions may relate to the same fracture or
admission, a new consultant episode is generated. to successive fractures. If they relate to two different
The continuous in-patient spell is the time spent fractures, the investigator needs to decide whether
04098-02.qxd 06/02/2004 14:26 PM Page 14
Conclusions 15
Decisions are also needed about the time interval The two-item social function scale of the SF-36
between the initial hospital episode and the date of could also be used (Ware and Sherbourne 1992).
re-admission; and about whether the counting of the The working group recommended that return to
time interval should start from the date of admission pre-fracture mobility (indicator 13) should be meas-
with the fracture or the date of discharge from the ured by the use of two ordinal scales assessing walk-
initial admission. ing ability and walking aids requirements (Parker
Further decisions are required about whether to et al. 1998). Mobility can also be measured by the
count all sources of re-admission or emergency Oxford Hip Score (OHS) (Dawson et al. 1996); this
re-admissions only; and about whether to count all was developed particularly for total hip replacement
re-admissions or only those for particular condi- and provides a short, reliable and valid measure sen-
tions (e.g. thromboembolism; specific complica- sitive to clinically important changes. The inclusion
tions of fracture). As an example, ORLS data show of OHS would make up for the information lost by
re-admission rates, for all causes of emergency not using indicator 12 relating to the activities of
re-admission following fractured proximal femur, daily living measured by the Barthel score.
of 4.3 per cent within 30 days and 8.3 per cent The attainment of patient-specified outcome goals
within 120 days of discharge. (indicator 14) was identified as an important outcome
measure. The working group were unable to recom-
mend a single measure, although they favoured the
CANDIDATE INDICATORS TO BE Binary Individualised Outcome Measure (Spreadbury
DERIVED FROM SURVEYS and Cook 1995) and the Canadian Occupational
Performance Measure (Law et al. 1994).
Five of the candidate indicators can be derived It should be possible to identify whether patients
from surveys, involving patients, carried out about have returned post-discharge to their pre-fracture
120 days after surgery. category of accommodation (indicator 15) from
Post-surgery pain (indicator 10) was recom- hospital patient administration systems, but their sta-
mended by the working group to be measured by tus at 120 days will need to be obtained by survey.
the Charnley Hip Score (Charnley 1972). It is widely Currently, accommodation categories are not part
used following hip surgery, and has a straightforward of an ordinal scale, so the indicator only identifies
scoring system that correlates well with the degree those who return to their pre-fracture category and
of mobility and ability to walk (Sutton et al. 1996). not those who have been able to obtain a more
There are other more sophisticated measures avail- independent accommodation setting. A three-point
able, but they are longer and more time-consuming accommodation ladder has been used to summarize
for elderly patients. discharge destinations for elderly people (Parker et al.
Two of the measures are longitudinal (indicators 1994), and this could be used for patients with
11 and 13), and these have particular derivation prob- fractured proximal femur.
lems as they require a baseline as well as a 120-day
assessment. As there is difficulty in achieving com-
pleteness, the number lost to follow-up should be CONCLUSIONS
presented with the results. The baseline measures
have to be made on retrospective data about the In any given situation, the purposes for which indi-
pre-fracture situation collected during the hospital cators are used need to be clearly thought through.
admission. The indicators which are most relevant to each pur-
In order to measure social integration (indicator pose need to be selected. Ideally, they should conform
11) the working group recommended using the to agreed definitions so that data and results can be
adapted, unweighted Social Isolation Scale from shared and compared. Linkage of hospital statistics,
the Nottingham Health Profile (Sutton et al. 1996). including linkage to death certificate data, will be an
04098-02.qxd 06/02/2004 14:26 PM Page 16
References 17
of hip fracture in Europe (SAHFE). Hip Int 8, national sentinel audit for stroke: a tool for
1015. raising standards of care. J R Coll Physicians
Parker, S. G., Du, X., Bardsley, M. J., Goodfellow, J., Lond 33, 4604.
Cooper, R. G., Cleary, R., Broughton, S. G., Secretary of State for Health (1998): Our Healthier
Streit, C., and James, O. F. W. (1994): Measuring Nation: A contract for health. HMSO, London.
outcomes in care of the elderly. J R Coll Spreadbury, P., and Cook, S. (1995): Measuring the
Physicians Lond 28, 42833. Outcomes of Individualised Care: The Binary
Public Health Development Unit NHS Executive Individualised Outcome Measure. City Hospital
(1998): Clinical Effectiveness Indicators: NHS Trust, Nottingham.
A consultation document. Department of Sutton, G., Foan, J., Hyndman, S., Todd, C.,
Health, London. Rushton, N., and Palmer, R. (1996):
Pulmonary Embolism Prevention Trial Collaborative Developing Measurable Indicators for the
Group (2000): Prevention of pulmonary Quality of Care of Hip Fracture Patients.
embolism and deep vein thrombosis with low Institute of Public Health, Cambridge.
dose aspirin: pulmonary embolism prevention Ware, J. E., and Sherbourne, C. D. (1992): The MOS
trial. Lancet 355, 1295302. 36-item short-form health survey (SF-36):
Rudd, A., Irwin, P., Rutledge, Z., Lowe, D., Wade, D., conceptual framework and item selection. Med
Morris, R., and Pearson, M. (1999): The Care 30, 47383.
04098-03.qxd 06/02/2004 14:28 PM Page 18
3
Economic evaluation
Nikos Maniadakis and Alastair Gray
New treatment
is more costly
Ceiling cost-effectiveness
QIV Given ceiling CE, QI
new treatment is
unacceptable
Comparator dominates and
it is always acceptable
New treatment
is less costly
Figure 3.1 The cost-effectiveness plane. Adapted from Anderson et al. (1986); Black (1990) and Maniadakis and Gray (2000).
we may face one of four situations, each repre- and effects, and the decision on which treatment to
sented graphically by the quadrants of the cost- accept depends upon the maximum amount that the
effectiveness plane in Fig. 3.1 (Anderson et al. 1986; decision-maker is willing to pay for a gain in effect-
Black 1990; Maniadakis and Gray 2000). In this iveness. This is depicted graphically in Fig. 3.1 by
diagram, the horizontal axis represents the difference the dotted line that goes through the origin. In
in the effect between the new intervention and the essence, much of economic evaluation is concerned
comparator, and the vertical axis represents the dif- to locate interventions on this cost-effectiveness
ference in costs. The second quadrant of the plane plane and help decision-makers decide whether or
represents a situation where the new treatment not to allocate funds to particular therapies. The
dominates its comparator because it is less costly remainder of the chapter discusses some of the main
and more effective. The opposite happens in the steps required to do this.
fourth quadrant, where the comparator existing
therapy dominates the new treatment. It is appar-
ent in such cases that the dominant therapy should HEALTH OUTCOME
be always preferred. MEASUREMENT AND VALUATION
By contrast, the decision is not so straightforward
in the other two quadrants. As is often the case in The choice of the outcome measure used to quan-
reality, the first quadrant depicts a situation where tify treatment effectiveness dictates the form of the
the new treatment is more effective but also more economic analysis to be performed, namely cost-
costly, whilst the third quadrant depicts a situation effectiveness, cost-utility or cost-benefit analysis.
where it is less effective and less costly. In these In cost-effectiveness analysis a single outcome of
circumstances, there is a trade-off between costs therapy is typically measured in terms of physical
04098-03.qxd 06/02/2004 14:28 PM Page 20
20 Economic Evaluation
or natural units, such as: number of complications Utility Index (HUI) and the Quality of Well-Being
avoided (Borghi and Lazzaro 1996), score in the Scale (QWB). These methodologies and instruments
Locomotion scale (Jonsson and Larsson 1991), and are discussed in detail elsewhere (Sloan 1995;
lives or life-years saved (OBrien et al. 1994). If the Gold et al. 1996; Johannesson 1996; Bowling 1997;
effectiveness of the treatments under consideration Drummond et al. 1997). Because quality of life is
is shown to be equivalent (or almost equivalent), important, but also because this type of analysis
then the objective becomes to find the alternative facilitates broad comparisons between health care
that minimizes costs. This is sometimes referred to interventions, cost-utility analyses are increasingly
as cost-minimization analysis (Grimer et al. 1997). common and many agencies such as NICE encour-
Sometimes, studies report costs and multiple out- age its use. Studies of this type are increasingly com-
comes separately, leaving their aggregation to the mon in orthopaedics (Parker et al. 1992; James
reader; these are referred to as cost-consequence et al. 1996).
analyses (Powell et al. 1994; Javid 1995). Finally, cost-benefit analysis attempts to report all
In cost-utility analysis the multiple effects of an costs and effects associated with an intervention in
intervention are quantified in terms of a single monetary terms, for example by estimating the
composite outcome measure, often termed by econ- value of life, thereby estimating the value of any
omists a utility index. This composite measure gains from an intervention, and comparing this with
reflects the valuations that individuals place on the costs of the intervention. Various approaches
particular states of health and consequently the can be used to convert health effects into monetary
well-being they derived from them. Utility is typically terms. In early research, according to the human
scaled from 0 to 1 (or 0 to 100), where 0 relates to capital approach, average earnings were attached
worst and 1 (or 100) to the best imaginable state to healthy working time gained as a result of an
of health. The product of the time in a particular intervention and the total value was then computed
health state, times the utility associated with that as the present value of future earnings. There are
health state is often referred to as a Quality few examples of this approach in this area of
Adjusted Life Year or QALY. If, for instance, hav- orthopaedics (Tunturi et al. 1979; Tredwell 1990;
ing a vertebral deformity is associated with a utility Brown et al. 1992; Versloot et al. 1992). A variant
value of 0.75, then a year of life with that fracture of this approach assumes that, after a certain period
is equivalent to 0.75 quality adjusted life-years. called the friction period (hence the name of the
Various methodologies and instruments exist for approach), any individual will be replaced at work
valuing health states. Disease-specific measures focus and hence society will occur no further loss from her
on specific diseases, for example osteoporosis (Lips or his absence (Koopmanschap et al. 1995). The
et al. 1997; Oleksisk et al. 2000), as opposed to human capital approach is not without shortcom-
generic measures that can be applied in a range of ings, as it assumes that earnings reflect productiv-
different disease or treatment settings to try to cap- ity, and places low valuations on those unemployed
ture overall health status. Techniques for eliciting or on low incomes.
valuations include the rating scale, magnitude esti- An alternative approach is to measure patient will-
mation, standard gamble, time trade-off and person ingness to pay for a certain health state or for an
trade-off approaches. The subjects questioned can intervention. This approach is underpinned by the
include patients, professional groups such as nurses idea that in the absence of a perfect market where
and doctors, or the general public. Evaluations can prices reflect the value of different commodities
measure health state utility directly or indirectly one can create hypothetical market situations and
though use of multi-attribute utility systems for ask subjects to express preferences and attach val-
which empirical utility functions and tariffs have ues to health states in terms of their willingness to
been estimated through research. Such systems for pay to attain them, or their willingness to accept
instance include the EuroQol EQ-5D, the Health payment to forego them. These methods of eliciting
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22 Economic Evaluation
study design for obtaining such information is the conducted properly, that the biases to which they
randomized double-blind controlled trial, with other are subject have been minimized, and that differ-
study designs ranked thereafter (Sheldon et al. 1993). ences in setting are acknowledged. It is also import-
Despite their advantages, the orthopaedics litera- ant to test for homogeneity before pooling results
ture contains very few economic evaluations along- (Gillespie et al. 1995; Sheldon 1996).
side randomized trials (Bourne et al. 1994; Borghi
and Lazzaro 1996; Faulkner et al. 1998; Fitzpatrick
et al. 1998; Goossens et al. 1998). This may be due COSTING
to the fact that these can sometimes be unnecessary,
inappropriate, impossible, inadequate or very costly Costs associated with an intervention can be classi-
to pursue (Black 1996). In addition, trials are often fied into various categories. Direct medical costs are
concerned with efficacy as opposed to effectiveness, associated with the patients medical care, and may
that is, efficacy in real-life terms. Trials may give include items such as hospitalizations, medications
robust answers and thus have high internal validity, and visits to professionals. Direct non-medical costs
but may not fully represent reality for a wide range include costs not directly associated with patient
of reasons: they are often carried out in centres of treatment, such as costs occurring in other sectors
excellence, frequently not representing the average (nursing, residential, social care) or carried by
practice; they may not recruit the average patient patients and their families, such as out-of-pocket
population because of strict entry criteria; and they expenses for various items associated with care.
may (as in many phase III trials of pharmaceuticals) Next, productivity losses are opportunity costs
compare new active treatments with placebos, the reflecting the loss to the society caused by patients
latter not being an option in reality. Thus, it is often inability to work during treatment, as a result of
argued that randomized trials may be the best venue their illness or side effects, or because of premature
for proving efficacy, safety and treatment quality, but mortality, or because relatives need to take time off
not the best venue for providing evidence on treat- work to provide informal care.
ment use and cost-effectiveness. Phase IV randomized Costing involves measuring the quantities of
and non-randomized naturalistic or observational resources consumed, and assigning unit costs (prices)
trials may have higher external validity, may reflect to these quantities to obtain a cost per patient. Often
reality to a great degree, and they may also capture economic evaluations make use of average costs
the effect of learning curves. In cases where trials are published at a national level. However, micro-costing
not available or feasible, the next best source of based on accurate resource utilization data specific
evidence may be cohort or case-control studies, fol- to the interventions under consideration, although
lowed by case reports and expert panels. However, time-consuming and laborious to collect, is likely
such studies are very vulnerable to bias and errors in be more accurate and reliable. Resource utilization
inference, and this increases uncertainty around their data such as hospital length of stay, numbers of con-
results, especially when small samples are involved. sultations or time in operating theatre, and medica-
Finally, evidence on effectiveness may come from tions given can be collected within the context of a
a literature review or from a meta-analysis: that is, randomized controlled trial, a naturalistic or obser-
a study which synthesizes data from a variety of vational trial, from hospital information systems and
primary clinical studies (Cutler et al. 1994; OBrien primary care databases, from databases of managed
et al. 1994; Borris and Lassen 1996; Grimer et al. care organizations and sickness funds, or from
1997). By pooling a number of primary studies, patient chart reviews and other records.
meta-analyses achieve large sample sizes and thus The theoretically correct price for a resource is its
make it possible to detect small differences in effects. opportunity cost that is, the value of the oppor-
It is crucial, however, to ensure that treatments are tunities foregone by not using the resources in the
comparable, that the original studies have been best alternative way but in practice market prices
04098-03.qxd 06/02/2004 14:28 PM Page 23
are often used instead. In most cases these are eas- where, during a five-year period, the costs of sur-
ily obtainable, but some difficulty surrounds the gery are initially higher than the comparator, but
valuation of resources such as volunteer, family, or are subsequently much lower, are shown in Table
leisure time, where one may argue that the oppor- 3.2 (Shvartzman et al. 1992). Hence a study with a
tunity cost is anything between zero, average earn- shorter follow-up period might well have reached
ings or average overtime earnings (Posnett and Jan a different (misleading) conclusion. Unfortunately,
1996). It is also difficult in many instances to esti- it is not always easy to determine in advance the
mate the costs of capital outlays such as building appropriate cut-off point, and this is manifested in
and equipment, and the overhead costs of resources disagreements between studies on the appropriate
such as administration which are not directly related time horizon for an evaluation, even when they are
to the treatment. Alternative ways of treating such focused on similar conditions (Javid 1995; James
costs are discussed by several authors (Sloan 1995; et al. 1996; Goossens et al. 1998).
Gold et al. 1996; Johannesson 1996; Posnett and Because it is often difficult or uneconomical to
Jan 1996; Drummond et al. 1997). undertake a study with appropriate long-term meas-
The costs measured in an evaluation depend on ured endpoints, intermediate or surrogate points
the perspective adopted. Most evaluations in ortho- may be used instead. Typical examples of intermed-
paedics are confined to direct medical costs, and iate endpoints include blood pressure, serum chol-
few studies have attempted to value costs incurred esterol or haemoglobin changes in which may be
outside the hospital sector. However, as noted good predictors of longer-term costs and health
before, it is possible that a treatment may transfer effects that occur over the course of decades. Because
costs from the hospital sector to the patients and evidence on treatment effectiveness is frequently
their families or to other sectors, and so these costs based on such intermediate endpoints, and because
should also be considered. This again underlines the time horizon of an economic evaluation needs
the desirability of adopting a broad societal approach to extend a long way beyond these endpoints and
in an economic evaluation. ideally needs to cover the patients lifetimes, it is
frequently necessary to extrapolate from interme-
diate to final endpoints using a range of mathemat-
ANALYTIC HORIZON AND ical models (OBrien et al. 1994; Gillespie et al.
DISCOUNTING 1995; James et al. 1996; Faulkner et al. 1998;
Fitzpatrick et al. 1998). Extrapolation beyond the
The time horizon of the study needs to be long period observed in a clinical study is not always
enough to capture all the major resource implica- straightforward, and the assumptions used should
tions and health effects associated with the treat- be justified and thoroughly tested.
ments assessed and the cut-off points should be Moreover, as comparisons are made in the present,
clearly defined. The results of a study on the man- measurements have to be adjusted for timing. This
agement of herniated lumbar intervertebral disc is because individuals have a positive rate of time
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24 Economic Evaluation
Table 3.3: Cost-effectiveness in the treatment of undisplaced subcapital fractures
preference: in other words, people in general prefer comparator needs to be justified, and the evaluation
desirable consequences (such as health improve- should always report incremental results, that is the
ments) to occur earlier and undesirable consequences additional costs which a treatment imposes relative
(such as costs) to occur later. Therefore, future effects to a comparator over the additional benefits it deliv-
and costs have to be discounted to the present. Dis- ers (Karlsson and Johannesson 1996; Briggs and Fenn
counting rates vary from one country over to the 1997; Weinstein and Stason 1977). The literature
next. In the UK, for many years the consensus among provides many examples of average cost-effectiveness
economists was that both costs and outcomes should ratios which can be misleading. Consider for instance
be discounted at the Treasury recommended rate of Table 3.3, which displays the costs and effects asso-
6 per cent per annum. Recently, however, NICE has ciated with treatments for hip replacement in the
issued guidance indicating that costs should be dis- case of undisplaced subcapital fracture (Parker et al.
counted at 6 per cent per annum and health out- 1992). The incremental analysis indicates that qual-
comes at 1.5 per cent per annum. In contrast, in the ity adjusted life gains come at much higher cost than
USA the rate recommended is 3 per cent for costs indicated by the average analysis, the reason being
and outcomes, while in many European countries the that the do-nothing option still yields some quality
discount rate is 45 per cent. Thus, for comparative adjusted life years, so attributing all the health out-
purposes analyses should be performed and reported come to the intervention is to overstate its effect.
using a range of rates (including 0 per cent).
MATHEMATICAL MODELLING
THE COMPARATOR AND
INCREMENTAL ANALYSIS It was noted earlier that, where the costs and effects
of an intervention take many years to occur, mod-
Economic evaluation is based on comparisons elling can be used to extrapolate in time. Modelling
between alternative courses of action. Thus, the is also useful where diseases are characterized by
cost-effectiveness of a treatment should always be multiple stages, when data and results need to be
established relative to an appropriate comparator, extrapolated from one setting to another, or where
which may be current practice, the least costly or research needs to compare two treatments that pre-
most effective existing alternative, or where it is viously have been individually assessed against a
meaningful a do-nothing option. The choice of the common option such as a placebo. Modelling can
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26 Economic Evaluation
0 Effect difference
Figure 3.3 Confidence region for the cost-effectiveness ratio. CHECKLIST FOR ECONOMIC
Adapted from OBrien et al. (1994); Van Hout et al. (1994); EVALUATION
Chaudhary and Stearns (1996) and Briggs et al. (1997).
A: The Framework
The background of the problem being addressed
intervals around the effect difference and cost dif-
and the general design of the programme under
ference, respectively. The ray that connects the
investigation, including the target population,
intersection of the two I bars with the origin of the
should be stated.
plane has a slope equal to the estimated cost-effec-
The type of analysis being performed should be
tiveness ratio, and the spherical area gives an
clearly stated and justified.
approximate idea of the variance around this ratio.
The comparator programme should be justified
Methods exist to measure the confidence interval
and properly described.
around the cost-effectiveness ratio precisely (OBrien
The perspective and the time horizon of the study
et al. 1994; Van Hout et al. 1994; Chaudhary and
should be justified and stated.
Stearns 1996; Briggs et al. 1997).
In recent years the field has experienced many B: Data and methods
other methodological advances, concerned with the All resources of interest in the analysis should be
handling of missing and censored data, the possible clearly identified, measured and valued.
interactions between health outcomes and treatment All outcomes of interest in the analysis should be
resources, the estimation of sample sizes on the basis clearly identified, measured and valued.
of incremental cost-effectiveness ratios, the analysis Methods of obtaining estimates of effectiveness,
of complex data sets collected alongside large multi- costs and quality of life valuations and the sources
national trials, and the application of Bayesian meth- of information should be given.
ods to economic evaluation (Wilke et al. 1998; C: Results
Claxton 1999; Willan and OBrien 1999). The base case results in terms of costs,
effectiveness and incremental cost-effectiveness
ratios should be clearly set out.
CONCLUSIONS The sensitivity of the results and the assumptions
and uncertainties should be reported.
Economic evaluations of healthcare interventions
are becoming more unavoidable and more common. D: Discussion
Despite its relative size and importance, ortho- The results should be placed in the context of
paedics as a field has seen only a limited number of other relevant economic evaluations.
04098-03.qxd 06/02/2004 14:28 PM Page 27
The relevance of the study and policy questions populations under actual or average conditions of
and any ethical or distributive implications should treatment provision
be discussed. Efficacy The degree to which a therapeutic
outcome is achieved in a patient population under
rigorously controlled and monitored
A GENERAL GLOSSARY OF TERMS circumstances, such as controlled clinical trials
Human capital approach Method of quantifying
Analytic (time) horizon Period over which the indirect cost of an illness in terms of
outcomes and costs are measured production loss measured by remaining lifetime
Average cost Total cost of a treatment or a market earnings lost
programme divided by the total quantity of Incremental cost effectiveness The ratio of the
treatment units provided incremental cost over the incremental
Comparator Treatment selected for comparison effectiveness of a treatment relative to a
in cost-effectiveness analysis; usually the most comparator
commonly used, the do-nothing, the most Indirect cost Costs not directly related to
cost-effective, the most effective or the least costly provision of a treatment, such as production
Cost-benefit analysis Type of analysis that losses due to morbidity, mortality or care giving
measures costs and benefits in pecuniary units Intangible costs Costs associated with the
and computes a net monetary gain or loss suffering, pain and loss of health due to a disease
Cost-consequence analysis Type of analysis that or a healthcare intervention
lists the costs and outcomes of treatments in a Marginal cost Additional cost of producing one
disaggregated form additional unit
Cost-effectiveness analysis Type of analysis in Modelling An analytic technique used to simulate
which costs are contrasted to a single outcome real-world processes and events and account for
typically measured in terms of physical or natural the uncertainties in the probabilities, costs and
units such as years of life gained outcomes related to specific treatments
Cost-effectiveness plane A two-dimensional Opportunity cost The value of forgone benefits
plane depicting the possible cost-effectiveness because a certain healthcare resource is not
differences between alternative treatments deployed to its best alternative use
Cost-minimization analysis Type of analysis Overhead cost Costs incurred when providing
which compares only the costs of treatments in services but not directly related to specific
the case of equal effectiveness treatment, such as building maintenance
Cost-utility analysis Type of analysis in which Perspective View point chosen for the analysis
costs are contrasted to a single health index when reporting the costs and healthcare
measure called utility which reflects quantity outcomes of an intervention; typical examples
as well as quality of life include healthcare system, government, society
Direct cost Costs related directly to the or insurer
treatment under consideration, e.g. drug costs, Productivity cost The cost associated with lost
doctor salaries or impaired ability to work or engage in leisure
Discounting rate Rate used to convert future activities due to morbidity and mortality
costs or outcomes into equivalent present values Quality Adjusted Life Year (QALY) A life-year
Economic evaluation The systematic comparison adjusted for the utility (quality) associated with
of the costs and health outcomes of healthcare the state of health during that year
interventions and programmes Scenario analysis Method of examining changes in
Effectiveness The degree to which a therapeutic results of an economic analysis when key variables
outcome is achieved in real-world patient are varied simultaneously
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28 Economic Evaluation
Sensitivity analysis Method of establishing 250 osteoarthritic patients: the impact on health
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society are willing to trade present for future Economics 6, 4915.
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Utility Composite measure which refers to the analysis in economic evaluation: a review of
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of health; it usually takes a value between 0 Briggs, A. H., Wonderling, D. E., and Mooney, C. Z.
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benefits. Pharmacoeconomics 15, 918. the Economic Evaluation of Pharmaceuticals.
Black, N. (1996): Why we need observational studies to CCOHTA. Ottawa.
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1, 769. A cost-effectiveness analysis of total hip
Black, W. C. (1990): The cost-effectiveness plane: arthroplasty for osteoarthritis of the hip. JAMA
a graphic representation of cost-effectiveness. 275, 85865.
Med Dec Mak 10, 21215. Chaudhary, M. A., and Stearns, S. C. (1996):
Borghi, B., and Lazzaro, C. (1996): Indobufen in the Estimating confidence intervals for cost-
prevention of complications in orthopaedic effectiveness ratios: an example from a
surgery: a pharmacoeconomic assessment. randomised trial. Stat Med 15, 144758.
Br J Med Econ 10, 12944. Claxton, C. (1999): The irrelevance of inference:
Borris, L. C., and Lassen, M. R. (1996): Thrombo- a decision-making approach to the stochastic
prophylaxis with low molecular weight heparin evaluation of health care technologies. Health
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Bourne, R. B., Rorabeck, C. H., Laupacis, A., et al. Abdel-Moty, E., Khalil, T. M., and Rosomoff, R. S.
(1994): A randomised clinical trial comparing (1994): Does nonsurgical pain center treatment
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Spine 19, 64352. improvement and costs of hip and knee
Drummond, M. F., OBrien, B., Stoddart, G. L., and arthroplasty in destructive rheumatoid arthritis.
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Faulkner, A., Kennedy, L. G., Baxter, K., et al. (1998): Koopmanschap, M. A., Rutten, F. F. H.,
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Health Technology Assessment 2(6), 1134. costs of disease. J Health Econ 14, 17189.
Fitzpatrick, R., Shortall, E., Sculpher, M., et al. (1998): Lips, P., Cooper, C., Agnusdei, D., Caulin, F., Egger, P.,
Primary total hip replacement surgery: a systematic Johnell, O., Kanis, J. A., Liberman, U., Minne, H.,
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04098-04.qxd 06/02/2004 14:27 PM Page 31
4
Randomized controlled trials
Jeremy C . T. Fairbank
RCTs have influenced epidemiologists more have been used in RCTs: Ligation of the internal
than orthopaedic surgeons. mammary artery for angina (Cobb 1959) and
arthroscopic surgery for osteoarthritis of the
In spite of this, RCTs are not often used in the knee (Moseley and OMalley 2002). This has to
surgical practice. There are a number of reasons be accepted as a limitation of all surgical RCTs,
why this might be, and these are discussed below. as special difficulties arise when comparing
surgical and non-surgical treatments.
OBSERVATIONAL VERSUS Blinding of the patient is usually impossible,
RANDOMIZED TRIALS although sometimes it is possible to mislead
observers with dummy dressings or to keep
Trialists have strongly held the view that the treat- patients clothed. It is important to develop
ment effect seen in observational studies is much outcomes which are unlikely to be biased by
larger than that seen in RCTs. It is usually easier to the unblinded observer, such as questionnaires
perform an observational study, although few have which are scored by someone else.
been carried out to the technical standard of RCTs.
This view has been challenged by Britton et al. (1998) There are a number of problems surrounding
in a study for NHS Health Technology assessment. surgical skills. If two operations are being
This view has been supported by a series of studies compared, a surgeon may be much better at
published in the New England Journal of Medicine one operation than another. An example is the
in 2000 (Benson and Hartz 2000; Concato et al. recent fastidious trial in Finland comparing
2000; Pocock and Elbourne 2000). No formal study three techniques of managing cervical disc
has been set up to test this hypothesis. disease. This involved the surgeons in using
An article which was strongly against observational an autograft-based interbody fusion, a
studies (MacMahon and Collins 2001) provoked a technique that they had abandoned years
storm of correspondence. Jahn and Razum (2001) before in preference for allografts. They had to
pointed out that observational studies tested real life relearn the old technique to complete the trial.
when treatment depends on the individual perform- There was little to choose between the three
ance of a health worker (AKA a surgeon!). Coomber groups, except that 80 per cent of their
and Perry (2001) suggested that an experiment (a patients had donor site pain (which seems very
trial) is fundamentally different from an observa- high, and might be blamed on surgical
tion, in that an experiment is designed to test a incompetence) (Savolainen et al. 1998).
hypothesis. Observation is to view the real world, However we can look back to an observational
and the latter should follow the former to test the study followed by a trial in Bristol which
experiments applicability the two processes are suggests that this finding is unexceptional
complementary. These authors also emphasize that (Rawlinson 1994). The real problem here is
most observational studies are poorly supported that the Finnish trial had only about 30
(Coomber and Perry 2001). patients in each group, which may well be
insufficient to reveal significant complications
or to demonstrate important differences
RANDOMIZED TRIALS IN SURGERY between the treatment groups. Surgeons
undoubtedly vary in their skills, and this
In 1992, Stirrat and colleagues spelled out some of
leads to problems of applicability. In other
the problems that arise with RCTs in surgery (Stirrat
words, just because one surgeon can get good
et al. 1992):
results, it does not mean that others can. In my
Placebo operations are unethical. There are at view, this is one of the great arguments for the
least two examples where placebo operations multicentre trial.
04098-04.qxd 06/02/2004 14:27 PM Page 33
Bias 33
New operations take time to develop and to motive for patients to join trials should not be
overcome the learning curve. It is impractical promoted. Trials can be about defining the best
to randomize all new interventions from the treatment for that individual patient, although
first patient, as has been quoted by Chalmers general conclusions can only be drawn once the
(Collins et al. 1996). study is complete.
Because operations have to take place in Surgeons lose money and kudos by submitting a
operating theatres constrained by schedules, new procedure to a trial. This also may be true.
availability and money, an RCT in surgery can
be very difficult to organize. For example, the Protocols are difficult to agree. Entry criteria
are too tight.
MRC Spine Stabilization Trial had difficulties
because the surgical budget and the physio- Although surgeons prefer randomization by centre,
therapy budget were rigid and distinct (Frost this develops many biases and is unacceptable. It is
et al. 1997). important that a multicentre trial uses stratification
to ensure that there is an even distribution of patients
Patients and surgeons are prejudiced over the
between treatment groups in each centre.
choice of procedure, which seriously interfere
with recruitment.
Randomization
Figure 4.1 The CONSORT statement (From: Begg, C., et al. (1996): JAMA 276, 6379; and Moher, D., et al. (2001): JAMA 285, 198791).
Subgroup analysis at the end of the trial is The protocol needs multiple revisions and
refinements. It should be shown around, and its
tempting, but often misleading. The subgroups
publication considered in advance of the trial.
that are to be analysed should be defined at the
design stage, so that sufficient numbers of patients The fine detail and organization behind a trial
will be in those groups for useful analysis. will make or break it.
The data collected at the time of randomization All collaborators involved in a trial should be
should form the basis for this analysis. aware of the commitment of time and effort
04098-04.qxd 06/02/2004 14:27 PM Page 37
Power
Stratification
The issues surrounding the application of trial find-
Unfortunately, the play of chance is such that a strong ing to clinical practice reflect a difference in percep-
confounding factor, is that it may cause an eccentri- tion between clinicians and epidemiologists. Trials
cally distribution of pre-defined subgroups. If there are built on classical statistics where the trial result
are well-recognized confounding factors, the ran- is compared with a null hypothesis that there is no
domization process can be stratified, so that a guar- difference between the outcome of two or more treat-
anteed equivalent number of individuals arrives in ment groups. The conventional criteria of P 0.05
each group. represents a better than 1 in 20 chance that the dif-
ference is not one caused by chance. A classic power
calculation is shown in Table 4.2. Sterne and Smith
The uncertainty principle (2001) have argued that in a world where thou-
sands of trials are performed this is insufficient to
It is ethical to enter a trial where both the patient and be convincing. They suggest much higher levels of
clinician are uncertain as to the outcome of treat- probability (say P 0.001) should become the nor-
ment in either arm. It is unethical to enter a trial mal threshold. The probability should be presented
where either the patient or clinician is certain of as a precise value and seen in the context of the
either a successful or unsuccessful outcome of one or study and other work, and not just in isolation. These
other treatment arm. Uncertainty does not come authors advocated fewer, bigger and more power-
easily to surgeons, although, in honesty, few of us ful studies echoing a longstanding theme from
can be totally confident of an outcome in any case. Richard Peto and his colleagues in Oxford (Collins
Similarly, patients must have confidence in their sur- et al. 1996).
geon. Expressions of uncertainty have to be explained
with care, and this requires that a patient is able to
grasp the concepts involved. Trial size
How large is large? The size of the trial depends
Outcome measures on the expected differences and outcome between
two groups which are of clinical significance. Both
Having identified the question, condition-specific increased variability and small differences to detect
outcome measures are needed. This is not easy, and is independently mean that more numbers are needed.
the main focus of this book. What are these measures Often, reliable data are difficult to come by in this
04098-04.qxd 06/02/2004 14:27 PM Page 39
References 39
Table 4.2: Power calculations for Oswestry Disability Index as an programmed cross-checks is essential. The data man-
outcome measure for the Spine Stabilisation Trial (Change of 50%
agement committee needs access to the data, which
to 30%; cf. 50% to 34%). Number of patients per group
cannot be shown to the trialists until the trial is com-
pleted. This means that there has to be someone
Number of subjects
expert in accessing the database who is not a trialist.
required per Standard Standard
Regular data backups with copies held in different
treatment group deviation 10 deviation 15
locations are essential.
P 0.01
90% Power 188 patients 420 patients
Ethics committees
80% Power 148 patients 330 patients
P 0.05 If the clinical question is valid, an ethical trial should
90% Power 133 patients 296 patients be constructable. Arrangements differ from coun-
80% Power 100 patients 222 patients try to country. Where local ethics committees or
Review Boards exist, a new submission will have to
be made to each committee, which may be a lot of
area, and indeed this is one of the reasons the trial work for either the local clinicians, trialists or trial
has been carried out in the first place. Pilot studies coordinator.
are sometimes useful not only in defining the differ-
ences in outcome but also in ironing out method-
ological difficulties in the principal trial design. It Funding
has been the universal experience of the large trial-
ists that larger is better, and some of these trials Multicentre trials are very expensive. Talk to poten-
have recruited more than 60 000 patients. Studies tial donors from the start, and take their advice.
should be designed to differentiate between clinically Beware of conflict of interest with commercial spon-
worthwhile differences of outcome and clinically sors, and obtain guarantees of funding through the
immaterial differences of outcome. The major theme trial. The trialists need to be in control of the final
of this book is to identify appropriate outcome meas- publications.
ures. The clinical relevance of the outcome measure
is of crucial importance. Lack of change of an out-
come measure in an individual patient may conceal
an important clinical benefit.
REFERENCES
Bailar, J., and Mosteller, F. (1986): Medical Uses of
Statistics. NEJM Books, Boston, Massachusetts.
Trial coordination Baum, M. (1999): Reflections on randomised controlled
trials in surgery. Lancet 353 (Suppl. 1), 68.
The trial administrator is a key person. He/she should Begg, C., Cho, M., Eastwood, S., et al. (1996):
have had experience in other clinical trials before Improving the quality of reporting of randomised
running a trial. The trial office will require expertise controlled trials: the CONSORT statement.
in data management, data entry, computing and, JAMA 276, 6379.
above all, good communications with other trial Benson, K., and Hartz, A. (2000): A comparison of
centres. A computer programmer is essential. There observational studies and randomized, controlled
are many commercial databases available, but trials. New Engl J Med 342, 187886.
all require careful management. The collected data Britton, A., McKee, M., Black, N., McPherson, K.,
is a most precious resource. Double entry with Sanderson, C., and Bain, C. (1998): Choosing
04098-04.qxd 06/02/2004 14:27 PM Page 40
5
Register studies
Leif I. Havelin, Birgitte Espehaug, Ove Furnes, Lars B. Engester,
Stein A. Lie and Stein E. Vollset
42 Register Studies
the quality of different prostheses, cements, and clinical failure is a problem. Sderman et al. (2000)
operative techniques, and to detect inferior implants evaluated revision as an end-point in the Swedish hip
and procedures as early as possible. In general, the register by analysing the clinical and radiographic
aims of medical registers might be to assess and outcome of 1113 randomly selected patients from
compare results of the different devices or treatments the register. These authors concluded that the failure
that are in use, and the most appropriate outcome end-point in the register (revision) was valid and very
or response measure must be defined accordingly. exact. The general experience is that in large per-
manent register studies on joint arthroplasty, revi-
sion surgery is the only practical end-point.
OUTCOMES
Revision surgery and prosthesis survival are usually PATIENT IDENTIFICATION AND
chosen as the outcome or response in arthroplasty FOLLOW-UP
registers. With baseline data on the primary oper-
ations and data from the revisions, the survival of dif- In the Scandinavian arthroplasty registers, the sur-
ferent implant components can be assessed and the geon reports the patients national personal identifica-
possible causes for revisions established. Further, if tion (ID) numbers for identification of the patient and
sufficient data are registered on age, gender, diagno- the surgery (Paavolainen et al. 1991; Knutson et al.
sis, operative techniques, use of antibiotic prophy- 1994; Herberts and Malchau 1997, 2000; Puolakka
laxis, and other patient-, surgeon- or hospital-related et al. 1999; Robertsson et al. 1999; Lucht 2000). In
risk factors, the impact of these risk factors on the some countries, such as Norway, the surgeon needs
revision rates can also be investigated. the patients consent to be allowed to send data with
Revision surgery is often the only outcome that is this information to most central registries, and the
reported to most arthroplasty registers, but quality registries must treat data with patients ID confiden-
of life measures, mortality, level of pain, satisfaction tially. By use of the ID numbers, the information on
and function, or X-radiography findings after differ- outcomes (revisions) can be linked to the baseline
ent time intervals might also be chosen as outcomes. information (primary operation) even if the outcome
is discovered or treated at another hospital than the
primary operation. With such a system, in which all
Comments hospitals and all surgeons are participating and where
data on patients deaths or emigration are available,
As the decision to revise the patient may depend on the follow-up of patients will be nearly complete.
many factors, it can be questioned if revision is In countries without national ID numbers or in
an adequate outcome variable. The proportion of regional registries, other systems for follow-up, such
patients who have their prostheses still in place gives as questionnaires to the surgeons or patients, must
no information on clinical and radiographic outcome be established.
or the patients satisfaction (Fender et al. 1999).
However, parameters such as quality of life mea-
sures, pain, function and X-radiography findings SELECTION OF A MINIMAL SET OF
might be more suitable only in smaller studies that NECESSARY DATA
are continuing for limited time periods. We consider
it impossible to get all the surgeons in a country to The recording of data should be based on individual
control every one of their patients and report the reports for each patient. A register should comprise
clinical and radiographic findings to the register. both baseline data (e.g. primary operations) and the
Furthermore, if revision surgery is not used as out- outcome response (e.g. revision) at follow-up. The
come, then the choice of level for the definition of a aims of the study must be decided upon early in
04098-05.qxd 07/02/2004 10:00 AM Page 43
Data Analysis 43
the planning process, and based on these aims deci- forms. In some registries, such as the Swedish hip
sions can be made about the minimal necessary set registry (Herberts and Malchau 2000), the data are
of well-defined data to be collected. reported by e-mail. Due to regulations on data
security in Norway, it is not permitted to send data
that contain patient information by e-mail.
RECORDED IMPLANT DATA
In an arthroplasty register, the date of the operation
(primary or revision) and information such as diag-
DATA ANALYSIS
nosis or reasons for reoperation, type of revision, In order to handle the large amounts of data in
approach, use of bone transplant, prostheses, a register study, a statistical program package is
cement, and antibiotic prophylaxis, are necessary. needed. The statistical packages most commonly
The Norwegian Arthroplasty Register collect data on used by the authors are the SPSS (SPSS, Inc., Chicago,
the proximal (e.g. cup), distal (e.g. stem), and inter- IL, USA) and the S-PLUS (Statistical Sciences, Inc.,
mediate (e.g. head) prosthesis components separately Seattle, WA, USA), although others are both avail-
and on a catalogue number level. In this way, results able and suitable (e.g. SAS, SAS Institute, Cary,
for the different implant designs, can be calculated NC, USA).
separately, both for proximal and distal components. Descriptive statistical data analyses must be carried
To ensure accurate information on the implant, the out, and follow-up times and demographic data for
surgeons may use stickers with catalogue numbers of the different compared treatment groups should be
the implants supplied by the manufacturers. given. Survival analyses have most commonly been
used in arthroplasty registers, but they are applicable
also to other fields of orthopaedic surgery, especially
COLLECTION OF DATA in studies where groups of patients with certain treat-
ments are followed until an outcome (response) such
As register studies usually cover longer time periods as healing or a complication.
and contain larger numbers of surgeons and patients
than most other study approaches, a few principles
should be emphasized at this point:
Survival analyses
Correct and complete reporting are most easily
achieved if the reporting is performed by the The different methods for calculation of survival
surgeon immediately after the operation has have in common that they analyse the length of time
been performed, or when the studied response
to a response (death, failure). The possibility to
has occurred.
include data from patients in which the response has
It is important to use short and simple forms, not yet occurred distinguishes survival analyses from
since the level of dedication may vary among other statistical methods (Benedetti et al. 1990).
the participants (Figs. 5.1 and 5.2). Such data are called incomplete or censored, and
they may arise from loss to follow-up, death, or no
As cases with incomplete information usually
response (failure) before the end of the study. The
cannot be included in the statistical analyses,
survival function is the probability that, for any
only information that is essential and easily
specific survival time, a subject will survive at least
available for the reporting surgeons should be
for that long or longer.
asked for.
Two methods for estimating the survivor functions
We are of the opinion that, at present, the report- are common. In the actuarial life-table method
ing to registers is most practical by the use of paper (Cutler and Edere 1958), the time-to-response is
04098-05.qxd 07/02/2004 10:00 AM Page 44
44 Register Studies
...................................................
(Surgeons name is not registered)
Figure 5.1 English translation of the form (from 1994) used for the reporting of hip replacements to the Norwegian Arthroplasty
Register. Reprinted with permission from J. Michael Ryan Publishing, Inc.
04098-05.qxd 07/02/2004 10:00 AM Page 45
Data Analysis 45
grouped into time intervals. For each time interval, regression it is possible to estimate relative failure
the life table records the number of patients still in risks with adjustment for multiple variables.
the study at the beginning of the interval, and the By linking information on the revisions (response)
number of responses and censored observations. to the primary operations by use of the patient ID
From these numbers the survival at the beginning numbers, the time to response is found, and survival
of each interval is estimated. This method has been of the implants or treatments can be assessed. If suf-
applied in orthopaedic surgery as described by Dobbs ficient data are collected, survival of the different
(1980). For register studies, the product-limit or prosthesis components (stem, polyethylene insert,
Kaplan-Meier method might be more appropriate head, and cup) with end-points such as all revisions
(Kaplan and Meier 1958). The advantage of this is or revision from aseptic loosening, dislocation, infec-
that it provides results which are independent of the tion, fracture, osteolysis, or pain can be estimated.
choice of time intervals, as the survival is estimated
at every response (failure) time. Another method KAPLAN-MEIER METHOD
is the Cox model, which is a multiple regression The Kaplan-Meier method is most commonly
analysis of survival times (Cox 1972). With Cox applied to estimate the prosthesis survival and to
Figure 5.2 English translation of the form used for the reporting of arthroplasties in joints other than the hip, to the Norwegian
Arthroplasty Register. Reprinted with permission from J. Michael Ryan Publishing, Inc.
04098-05.qxd 07/02/2004 10:00 AM Page 46
46 Register Studies
Type of revision (one or more): Cruciate ligaments
1 Change of distal component 1 Anterior, intact before operation 0 No 1 Yes
2 Change of proximal component 2 Anterior, intact after operation 0 No 1 Yes
3 Change of all components 3 Posterior, intact before operation 0 No 1 Yes
4 Change of patella component 4 Posterior, intact after operation 0 No 1 Yes
5 Change of polyethylene: ................................
6 Removal. OTHER JOINTS:
Components: ............................................ Prosthesis type:
7 Insert of patella component 1 Total 2 Hemi 3 One-component prosthesis
8 Other:
........................................................................... Proximal component:
Structural bone transplant: 0 No Name/size:
1 Autograft 2 Allograft 3 Bone impaction prox. ............................................................
4 Bone impaction distal 5 Other: ................. Catalogue number:
...........................................................
Systemic Antibiotic prophylaxis: 1 Cement with antibiotic.
0 No 1 Yes: Name: ...........................................................
Type ................. Combinations ................. 2 Cement without antibiotic.
Dosage ................. Duration, days ................. Name: ............................................................
3 Uncemented
Duration of operation: .................
Peroperative complication: Distal component:
0 No 1 Yes: Name/size:
Type: .................................................................... ............................................................
Catalogue number:
............................................................
1 Cement with antibiotic.
Name: ............................................................
2 Cement without antibiotic.
Name: ............................................................
3 Uncemented
............................................................
(Surgeons name is not registered)
Figure 5.2 English translation of the form used for the reporting of arthroplasties in joints other than the hip, to the Norwegian
Arthroplasty Register. continued
construct survival plots, with different end-points (age, gender, diagnosis and others) can be assessed,
as described above. By using the log-rank test, the and corresponding Cox-adjusted survival curves
statistical significance of differences can be assessed. can be constructed.
However, the Kaplan-Meier method does not
provide any possibilities to adjust for confounding HOMOGENEOUS SUBGROUPS
factors. Another way to handle prognostic differences in sub-
groups of patient materials, is to limit the inclusion
COX MULTIPLE REGRESSION of patients in the analyses to certain patient groups
With the Cox model, relative risks for revision can (e.g. to only one gender, or most commonly, to cer-
be assessed with adjustment for differences in the tain age groups within a diagnostic group). A com-
compared treatment groups concerning age, gen- bination, where the Cox model is applied on a
der, diagnosis and other confounding factors. The homogenous group of patients, is often the best
impact on the results of the confounding factors solution.
04098-05.qxd 07/02/2004 10:00 AM Page 47
Statistical Expertise 47
PATIENTS DEATHS identification of inferior results of several brands of
Data on deceased patients are needed in register stud- threaded cups and smooth uncemented stems were
ies. In survival analyses, intact implants in dead (or documented with about 200 implants of each brand
emigrated) patients are followed from the primary registered during the first three-year period that the
operation until the date of death (or emigration) register was functioning (Havelin et al. 1995b, c).
when the follow-up of these patients are stopped, The inferior results of the Boneloc cement, which
and their follow-up times are included as censored was used in most European countries between 1991
observations. The patients dates of death can be and 1995, was documented after this cement had
obtained from national population registries. In been in use for three years (Havelin et al. 1995a).
countries without such registries or if national ID During the 1970s, before the register was started,
numbers are not available, other methods must be about 6000 Christiansen prostheses (Sudmann et al.
found to collect the data on deaths, as these are 1983) and 2200 double-cup prostheses were used
needed to perform most survival analyses. in this country before results from randomized
In the Swedish registry a Poisson regression model trials could document their inferior results.
has sometimes been used (Malchau et al. 1993).
With that model, the patients individual baseline CEMENTED VERSUS UNCEMENTED
data and dates of deaths are not strictly necessary, POROUS-COATED ACETABULAR CUPS
but if these data are not included then the possibil- A comparison of cemented cups and uncemented
ity to adjust for confounding factors will be either hemispheric porous-coated acetabular cups regis-
lost or reduced. tered in the Norwegian Arthroplasty register from
19872000 will be used as an example.
Examples Results
The main finding was that the cemented cups per-
It has been possible to find and document inferior formed better than the uncemented hemispheric
results of prostheses and cements based on data porous-coated cups (Fig. 5.3a, b, c; Table 5.2). The
from the Norwegian Arthroplasty Register. Early difference was less pronounced after adjustment in
04098-05.qxd 07/02/2004 10:00 AM Page 48
48 Register Studies
Table 5.1: Patient characteristics by cup design
the Cox model, and when the analyses were per- confounded results. However, randomized studies are
formed on patients under the age of 60 years, which rarely performed in orthopaedic surgery for several
is the age-group that ordinarily receives uncemented reasons. They are difficult to organize, are expensive,
porous-coated cups. require a large workload, and take a long time using
a consistent technique. This applies especially to
Comments fields such as arthroplasty surgery where the results
The uneven distribution of diagnosis, age and in general are good. Since differences among treat-
gender as seen in the two study groups had an ments are small, large numbers of patients and long
influence on the results. These differences were follow-up are needed to be able to detect statistic-
taken care of by selecting a more homogenous sub- ally significant differences.
groups of patients and by adjustment in the Cox A randomized trial can only address one or two
model (see Table 5.2 and Fig. 5.3). We consider the primary research questions. As long as results from
results from the Cox model, on patients under the clinical trials are not mandatory before new implants
age of 60 years, to be most valid. As seen in Fig. 5.3, or treatments can be freely used, the number of
the curves follow each other until about six years trials will remain limited.
of follow-up, but thereafter they diverge. The risk As results from clinical trials with satisfactory
ratios could have been assessed separately for the long follow-up periods do not exist for the major-
time periods 0 to 6 years and 6 to 13 years. A larger ity of joint replacement devices, one alternative is to
difference than that shown in Table 5.2 would then use register studies. With this approach, results for
have been found during the last period. practically all different implant- or treatment modi-
fications reported to the register can be assessed
with minimal workload for the reporting surgeons.
STATISTICAL CONSIDERATIONS Because of the huge numbers in a national register,
it is commonly possible to find significant results
The ideal approach to evaluate the performance of earlier than in randomized studies. The results from
implants and techniques would be to carry out RCTs. register studies will also reflect the outcome for the
Properly conducted large randomized trials would average surgeon rather than for specialized centres.
eliminate any systematic differences between the With arthroplasty registers, it has been possible to
different treatment groups that might lead to identify inferior results of some implants after only
04098-05.qxd 07/02/2004 10:00 AM Page 49
Statistical Considerations 49
100
three years if the differences are large, but to find
All-polyethylene and document small differences, larger numbers of
95 patients and longer observation usually are needed.
Prosthesis survival (%)
Page 50
All patients <60 years
Cup design 10-yr (%) 95% CI RR 95% CI P 10-yr (%) 95% CI RR 95% CI P RR 95% CI P
1
Survival probabilities at 10 years based on the Kaplan-Meier method.
2
Revision risk ratios (RR) for cup design based on a Cox regression model with adjustment for potential confounding by gender, age at primary operation (50, 5059, 6069,
7079, 80 years) and diagnosis (primary coxarthrosis, other). Survival probabilities at 10 years estimated with cup design as strata factor.
04098-05.qxd 07/02/2004 10:00 AM Page 51
52 Register Studies
surgeons with their statistical work. The register inferior implants before they are used in large
also has one research fellow who is financed exter- numbers of patients.
nally, and regular (weekly) meetings are held with a
professor at the Section for medical statistics at the
University of Bergen. REFERENCES
Benedetti, J., Young, K., and Young, L. (1990): Life
Tables and Survivor Functions. In: Dixon, W. J.
Funding (ed.), BMDP Statistical Software Manual.
Berkeley, California, USA: University of
Funding has been a major problem in establishing
California Press, pp. 72969.
most joint replacement registries. The health author-
Benson, K., and Hartz, A. J. (2000): A comparison
ities usually have a great interest in register studies,
of observational studies and randomized,
but experience shows that it takes time to obtain
controlled trials. N Engl J Med 342, 187886.
financial support from this source. At the present
Concato, J., Shah, N., and Horwitz, R. I. (2000):
time (2001), the Government covers practically all
Randomized, controlled trials, observational
expenses for the Norwegian Arthroplasty Register,
studies, and the hierarchy of research designs.
which is about 1.4 million NOK or 175 000 Euro
N Engl J Med 342, 188792.
annually. The cost per hip replacement is approxi-
Cox, D. (1972): Regression models and life tables
mately 22 Euro. By comparison, in Trent (England),
(with discussion). J Roy Statist Soc B 34,
data available from the register shows the cost for
187220.
total hip replacement to be approximately 50
Cutler, J. S., and Edere, F. (1958): Maximum
(Fender et al. 1996).
utilization of the life-table method in analyzing
If the financial resources cannot be obtained from
survival. J Chron Dis 8, 699713.
an independent source, then one possibility is to
Dobbs, H. S. (1980): Survival of total hip replacement.
allow each hospital to pay a fee per registered
J Bone Joint Surg Br 62B, 16873.
implant. Some registries also obtain financial sup-
Fender, D., Harper, W. M., and Gregg, P. J. (1996):
port from industry sources, although in such cases
Need for a national arthroplasty register.
it is preferable that many or all manufacturers are
Funding is important. Br Med J 313, 1007.
involved, rather than the register being financed by
Fender, D., Harper, W. M., and Gregg, P. J. (1999):
one company. As case registries most often will
Outcome of Charnley total hip replacement
assess the results of implants or treatment systems
across a single health region in England: the
provided by industrial companies, it is preferable
results at five years from a regional hip register.
that implant registries remain economically inde-
J Bone Joint Surg Br 81, 57781.
pendent from the industry.
Havelin, L. I., Espehaug, B., Vollset, S. E., and
Engester, L. B. (1995a): The effect of cement
type on early revision of Charnley total hip
CONCLUSION prostheses. A review of 8,579 primary
arthroplasties from the Norwegian Arthroplasty
In fields where too few randomized studies are per- Register. J Bone Joint Surg Am 77-A, 154350.
formed, register studies might be the most practical Havelin, L. I., Espehaug, B., Vollset, S. E., and
solution to the problem of data acquisition. Registers Engester, L. B. (1995b): Early aseptic
may function as tools in surveillance and quality loosening of uncemented femoral components
control, and the register data provide a good basis in primary total hip replacement. A review
for research. The present authors experience is based on the Norwegian Arthroplasty Register.
that, by the use of a register it is possible to detect J Bone Joint Surg Br 77-B, 1117.
04098-05.qxd 07/02/2004 10:00 AM Page 53
References 53
Havelin, L. I., Vollset, S. E., and Engester, L. B. (1995c): Malchau, H., Herberts, P., and Ahnfelt, L. (1993):
Revision for aseptic loosening of uncemented Prognosis of total hip replacement in Sweden.
cups in 4,352 primary total hip prostheses. Follow-up of 92,675 operations performed
A report from the Norwegian Arthroplasty 19781990. Acta Orthop Scand 64, 497506.
Register. Acta Orthop Scand 66, 494500. Paavolainen, P., Hmlainen, M., Mustonen, H., and
Havelin, L. I., Engester, L. B., Espehaug, B., Furnes, O., Sltis, P. (1991): Registration of arthroplasties
Lie, S. A., and Vollset, S. E. (2000): The in Finland. A nation-wide prospective project.
Norwegian Arthroplasty Register: 11 years and Acta Orthop Scand 62, 2730.
73,000 arthroplasties. Acta Orthop Scand 71, Puolakka, T. J., Pajamaki, K. J., Pulkkinen, P. O., and
33753. Nevalainen, J. K. (1999): Poor survival of
Herberts, P., and Malchau, H. (1997): How outcome cementless Biomet total hip: a report on 1,047
studies have changed total hip arthroplasty hips from the Finnish Arthroplasty Register.
practices in Sweden. Clin Orthop 344, 4460. Acta Orthop Scand 70, 4259.
Herberts, P., and Malchau, H. (2000): Long-term Robertsson, O., Dunbar, M. J., Knutson, K., Lewold, S.,
registration has improved the quality of hip and Lidgren, L. (1999): The Swedish Knee
replacement: a review of the Swedish THR Arthroplasty Register: 25 years experience.
Register comparing 160,000 cases. Acta Bull Hosp Joint Dis 58, 1338.
Orthop Scand 71, 11121. Sderman, P., Malchau, H., and Herberts, P. (2000):
Kaplan, E. L., and Meier, P. (1958): Nonparametric Outcome after total hip arthroplasty: Part I.
estimation from incomplete observations. J Am General health evaluation in relation to definition
Statist Assoc 53, 45781. of failure in the Swedish National Total Hip
Knutson, K., Lewold, S., Robertson, O., and Lidgren, L. Arthroplasty register. Acta Orthop Scand 71,
(1994): The Swedish knee arthroplasty register. 3549.
A nation-wide study of 30,003 knees Sudmann, E., Havelin, L. I., Lunde, O. D., and Rait, M.
19761992. Acta Orthop Scand 65, 37586. (1983): The Charnley versus the Christiansen
Lucht, U. (2000): The Danish Hip Arthroplasty total hip arthroplasty. Acta Orthop Scand 54,
Register. Acta Orthop Scand 71, 4339. 54552.
04098-06.qxd 06/02/2004 14:29 PM Page 54
6
Measures of health status, health-related quality of
life and patient satisfaction
Raymond Fitzpatrick
Sensitivity to Change 55
change. How such properties are assessed in health VALIDITY
status measures are considered in turn.
The validity of instrument is an assessment of the
extent to which it measures what it purports to
RELIABILITY measure. It is rarely, if ever, possible to identify a gold
standard against which to assess health status instru-
Reliability is concerned with the amount of ran- ments. Thus, criterion validity is not feasible.
dom and systematic measurement error to be found Instead, face and content validity are used to examine
in an instrument, and is assessed in terms of repro- whether items appear to address the important issues
ducibility and internal consistency. Reproducibility in a construct. Such judgements can be made by
evaluates whether an instrument yields the same patients and clinicians. Appropriate patients should
results on repeated applications, when respondents have been involved in the development of items.
have not changed on the domain being measured. Construct validity is a more quantitative form of
This is assessed by test-retest reliability. The degree assessment of validity. The construct, for example,
of agreement is examined between scores at a first disability, intended to be measured by an instrument,
assessment and when reassessed. Respondents can, is expected to have a set of quantitative relation-
if necessary, be asked whether a change has occurred ships with other constructs, such as age, disease sta-
in the domain, and those answering positively tus and recent use of healthcare facilities. No single
excluded from the test of reproducibility. Commonly correlation provides sufficient support for construct
reproducibility is expressed in terms of a correlation validity; a cumulative pattern of evidence is required.
coefficient between scores, but it is equally import- The Arthritis Impact Measurement Scale (AIMS),
ant to assess whether a shift in the distribution of described below, was developed as an instrument to
scores has occurred. The reproducibility of the assess health status in the rheumatic diseases (Meenan
Oxford Knee Score was tested by asking 66 patients 1982). One aspect of the assessment of the construct
to complete the instrument on two occasions, 24 validity of AIMS was to examine patterns of cor-rela-
hours apart (Dawson et al. 1998). The correlation tions with clinical rating scales. For example, scales of
coefficient between scores was very high, r 0.92. AIMS concerned with lower-limb function correlated
Equally importantly, there was no significant more with clinical ratings of walking time than meas-
change in the distribution of scores as examined ures of grip strength. Conversely, the scale of AIMS
by t-test. concerned with dexterity was more correlated with
Internal consistency can be tested when there are grip strength than the clinical assessment of walking
several items (forming a scale), rather than a single time. The AIMS pain scale correlated best with the
item, to measure constructs. This practice is based number of joints affected. These associations, which
on a basic principle of measurement that several were broadly consistent with those expected, were
related observations will produce a more reliable further tested in a range of patient groups with differ-
estimate than one. For this to be true, the items of a ing clinical and demographic characteristics. It was
scale need to measure aspects of only one attribute the overall pattern of correlations that contributed to
(known as homogeneous). Internal consistency can the evidence for construct validity.
be measured by split-half reliability, the degree of
agreement of two halves of the items in the scale.
Most commonly internal consistency is measured SENSITIVITY TO CHANGE
by means of Cronbachs alpha, essentially the aver-
age level of agreement of all possible split-half tests It is essential that health status instruments are sen-
for a set of items (Cronbach 1951). The range of sitive to changes over time within individuals, when
Cronbachs alpha is from 0.0 to 1.0, with values used in clinical trials or any other form of evaluative
between 0.70 and 0.90 considered optimal. research. It is possible for an instrument to be
04098-06.qxd 06/02/2004 14:29 PM Page 56
Patient Satisfaction 59
or hip replacement surgery before and six months or value from respondents regarding their health.
after surgery. They showed that, whilst patients Utility measures have occasionally been used in the
experienced very substantial improvements in pain assessment of outcome of orthopaedic surgery, but
and physical function, changes to psychosocial func- it is not clear from such studies what advantages they
tion were much smaller. Improvements were greater have over simpler methods (Laupacis et al. 1993).
for patients receiving hip compared with knee
replacement surgery.
PATIENT SATISFACTION
INDIVIDUALIZED MEASURES A quite different focus in patient assessed measures
is provided by examining patient satisfaction. Instead
One criticism levelled against all of the approaches of asking patients about aspects of their health sta-
reviewed so far is that patients views and experi- tus, questions focus upon their judgements of the suc-
ences are assessed by means of standardized items cess, acceptability and value of healthcare received.
predetermined by researchers. Patients receiving Most commonly, studies of patient satisfaction have
orthopaedic surgery may have concerns that are not focused upon non-clinical aspects of care. These
addressed by such instruments (Wright et al. 1994). include courtesy and communication from health
To respond to such challenges, a number of instru- professionals, and the accessibility and convenience
ments have begun to appear that have in common of services (Fitzpatrick 1991). However, in the field
that they are designed for patients to identify their of orthopaedics questionnaires have proved particu-
own concerns rather than respond to predetermined larly helpful in obtaining evidence of patients views
categories. One of the earliest of so-called individ- about the outcomes of their surgery. For example,
ualized instruments to appear was the Schedule for Kay et al. (1983) carried out a survey of patients
the Evaluation of Individual Quality of Life approximately one year after total hip replacement
(SEIQoL) (OBoyle et al. 1992). This system requires surgery and found that 90 per cent of patients were
detailed interviewing in order to persuade patients satisfied with the outcome of their surgery; the
to identify their five most important personal con- remainder were either dissatisfied or uncertain. An
cerns with regard to quality of life and then rate indication of the validity of the results was provided
them. When applied to patients undergoing total by the higher rate of dissatisfaction in patients under-
hip replacement surgery, the SEIQoL appeared to going revision surgery. A follow-up study of patients
be less sensitive to change over time than more con- on the Swedish Knee Arthroplasty Register asked
ventional measures (OBoyle et al. 1992). patients to rate their satisfaction with their knee sur-
Another individualized instrument, the McMaster- gery on a single four-point scale from very satis-
Toronto Arthritis (MACTAR) Patient Preference fied to dissatisfied (Robertsson and Dunbar 2001).
Disability Questionnaire in this case asking res- Overall, 81 per cent of patients were satisfied, with
pondents to identify three aspects of life adversely dissatisfaction being higher in patients undergoing
affected by arthritis has been used specifically to revision surgery. Patient satisfaction was found to
assess outcomes of hip replacement surgery (Laupacis be higher in those patients with more favourable
et al. 1993). scores for pain and physical function on a range of
Instruments such as SEIQoL and MACTAR are health status measures. Importantly, the response
very similar in format to the utility measures used by rate of patients to the patient satisfaction question-
health economists. The main similarity is that both naire was 95 per cent, whereas responses to health
individualized and utility measures normally require status questionnaires such as SF-36 and NHP were
interviews because complex judgements are required considerably lower. This suggests a specific advan-
of the respondent. The utility measure is different in tage in terms of acceptability of the shorter and
that it is intended to obtain a single overall preference simpler questions about satisfaction.
04098-06.qxd 06/02/2004 14:29 PM Page 60
References 61
Bowling, A. (1995): Measuring Disease. Open responsiveness: a critical review and
University Press, Buckingham. recommendations. J Clin Epidemiol 53, 45968.
Bullens, P. H., van Loon, C. J., de Waal Malefijt, M. C., Jones, C. A., Voaklander, D. C., Johnston, D. W., and
Laan, R. F., and Veth, R. P. (2001): Patient Suarez-Almazor, M. E. (2000): Health related
satisfaction after total knee arthroplasty: a quality of life outcomes after total hip and knee
comparison between subjective and objective arthroplasties in a community based population.
outcome assessments. J Arthroplasty 16, J Rheumatol 27, 174552.
7407. Kay, A., Davidson, B. E. B., and Wagstaff, S. (1983):
Cronbach, L. (1951): Coefficient alpha and the internal Hip arthroplasty: patient satisfaction. Br J
structure of tests. Psychometrika 16, 297334. Rheumatol 22, 2439.
Dawson, J., Fitzpatrick, R., Carr, A., and Murray, D. Knutsson, S., and Engberg, I. B. (1999): An evaluation
(1996): Questionnaire on the perceptions of of patients quality of life before, 6 weeks and
patients about total hip replacement. J Bone Joint 6 months after total hip replacement surgery.
Surg 78-B, 18590. J Adv Nurs 30, 134959.
Dawson, J., Fitzpatrick, R., Frost, S., Gundle, R., Laupacis, A., Bourne, R., Rorabeck, C., Feeny, D.,
McLardy-Smith, P., and Murray, D. (2001): Wong, C., Tugwell, P., Leslie, K., and Bullas, R.
Evidence for the validity of a patient-based (1993): The effect of elective total hip
instrument for assessment of outcome after replacement on health-related quality of life.
revision hip replacement. J Bone Joint Surg Br J Bone Joint Surg Am 75-A, 161926.
83, 11259. Meenan, R. F. (1982): The AIMS approach to health
Dawson, J., Fitzpatrick, R., Murray, D., and Carr, A. status measurement: conceptual background and
(1998): Questionnaire on the perceptions of measurement properties. J Rheumatol 9, 7858.
patients about total knee replacement. J Bone Nilsdotter, A. K., Roos, E. M., Westerlund, J. P.,
Joint Surg Br 80, 639. Roos, H. P., and Lohmander, L. S. (2001):
Dunbar, M. J., Robertsson, O., Ryd, L., and Lidgren, L. Comparative responsiveness of measures of pain
(2001): Appropriate questionnaires for knee and function after total hip replacement. Arthritis
arthroplasty. Results of a survey of 3600 patients Rheum 45, 25862.
from the Swedish Knee Arthroplasty Registry. Nilsson, L., Franzen, H., Carlsson, A., and Onnerfalt, R.
J Bone Joint Surg Br 83-B, 33944. (1994): Early radiographic loosening impairs the
Fitzpatrick, R. (1991): Surveys of patient satisfaction I function of a total hip replacement. J Bone Joint
important general considerations. Br Med J 302, Surg 76-B, 2359.
8879. OBoyle, C., McGee, H., Hickey, A., OMalley, K., and
Fitzpatrick, R., Davey, C., Buxton, M., and Jones, D. Joyce, C. (1992): Individual quality of life in
(1998): Evaluating patient-based outcome patients undergoing hip replacement. Lancet 339,
measures for use in clinical trials. Health Technol 108891.
Assessment 2, 174. Robertsson, O., and Dunbar, M. (2001): Patient
Fries, J., Spitz, P., and Young, D. (1982): The dimensions satisfaction compared with general health and
of health outcomes: the Health Assessment disease-specific questionnaires in knee
Questionnaire, disability and pain scales. arthroplasty patients. J Arthroplasty 16, 47682.
J Rheumatol 9, 78993. Sprangers, M., and Aaronson, N. (1992): The role of
Hunt, S., McEwan, J., and McKenna, S. (1985): health care providers and significant others in
Measuring health status: a new tool for clinicians evaluating the quality of life of patients with
and epidemiologists. J Roy Coll Gen Pract 35, chronic disease: a review. J Clin Epidemiol 45,
1858. 74360.
Husted, J. A., Cook, R. J., Farewell, V. T., and Stucki, G., Liang, M. H., Phillips, C., and Katz, J. N.
Gladman, D. D. (2000): Methods for assessing (1995): The Short Form-36 is preferable to the
04098-06.qxd 06/02/2004 14:29 PM Page 62
7
The measures of pain
Henry J. McQuay
It would be wonderfully helpful to have objective signs of subjective change; but it seems
unlikely that many such aids will be readily available in any precise way for years to come.
Beecher (1959)
Pain intensity scale that they are simple and quick to score, avoid impre-
LEAST WORST cise descriptive terms, and also provide many points
possible possible from which to choose. However, more concentra-
pain pain
tion and coordination are needed, and this can be
Pain relief scale difficult post-operatively or in patients with neuro-
NO COMPLETE logical disorders.
relief of relief of
pain pain
Figure 7.2 Visual analogue scales for pain intensity and pain relief.
Pain relief versus pain intensity
For analysis numbers are given to the verbal cat- Pain relief scales are perceived as more convenient
egories (for pain intensity, none 0, mild 1, mod- than pain intensity scales, probably because patients
erate 2 and severe 3; and for relief none 0, have the same baseline relief (zero), whereas they
slight 1, moderate 2, good or lots 3 and com- could start with different baseline intensity (usually
plete 4). Data from different subjects are then moderate or severe). Relief scale results are then
combined to produce means (rarely medians) and easier to compare, and may also be more sensitive
measures of dispersion (usually standard errors of than intensity scales (Sriwatanakul et al. 1982;
means). The validity of converting categories into Littman et al. 1985). A theoretical drawback of relief
numerical scores was checked by comparison with scales is that the patient has to remember what the
concurrent visual analogue scale measurements pain was like to begin with.
(Fig. 7.2). A good correlation was found, especially
between pain relief scales using cross-modality
matching techniques (Scott and Huskisson 1976; Numerical rating scales (Likert)
Wallenstein et al. 1980; Littman et al. 1985). Results
are usually reported as continuous data, mean or Numerical rating scales (NRS), also called Likert or
median pain relief or intensity. Few studies present ordinal scales, are analogous to the VAS in that they
results as discrete data, giving the number of par- are generally 100 mm long and have the same anchor
ticipants who report a certain level of pain intensity points, but the answers are constrained to the 11
or relief at any given assessment point. The main or 7 possible responses, rather than freely ranging
advantages of the categorical scales are that they across the line. NRS are considered both valid and
are quick and simple. The small number of descrip- sensitive with a significant correlation to other meas-
tors may force the scorer to choose a particular cat- ures of pain intensity (Jensen and McFarland 1993)
egory when none describes the pain satisfactorily. and are said to be easier for some patients to use.
They have been used widely in recent trials of anti-
convulsants in neuropathic pain (Farrar et al. 2001).
Visual analogue scales
Visual analogue scales (VAS), which are lines with Global rating scales
the left-hand end labelled no relief of pain and the
right-hand end labelled complete relief of pain, Global rating scales are designed to measure overall
seem to overcome this limitation. Patients mark the treatment performance. For research and clinical
line at the point which corresponds to their pain. purposes, we use a modified global scale which is pri-
The scores are obtained by measuring the distance marily categorical. The patient is asked the question,
between the no relief end and the patients mark, usu- How effective was the treatment?, using five cat-
ally in millimetres. The main advantages of VAS are egories (poor, fair, good, very good, and excellent).
04098-07.qxd 06/02/2004 14:29 PM Page 65
Analysis of scale results: summary peak are important, then knowledge is necessary of
measures the time to maximum pain relief (or reduction in pain
intensity) or time for pain to return to baseline.
In the research context, pain is usually assessed
before the intervention is made, and thereafter on
multiple occasions. Ideally, the area under the MEASURING PAIN IN CLINICAL
timeanalgesic effect curve for the intensity (sum of PRACTICE
pain intensity differences; SPID) or relief (total pain
relief; TOTPAR) measures is derived: Pain charts used as part of normal practice will
n n improve quality of care (Gould et al. 1992; Rawal
SPID
t1
PIDt TOTPAR PR
t1
t and Berggren 1994). The increasing trend in North
America is for pain to be regarded as the fifth vital
where at the tth assessment point, (t 0, 1, 2, n) sign, to be recorded at the same times as the other
Pt and PRt are pain intensity and pain relief meas- vital signs, and the fact of a chart is probably more
ured at that point, respectively; P0 is pain intensity important than its form. An example of this is the
at t 0; and PIDt is the pain intensity difference Burford chart (Burford Nursing Development Unit
calculated as (P0 Pt). 1984), of which special scales are available for chil-
These summary measures reflect the cumulative dren (McGrath et al. 1993). The chart which patients
response to the intervention. Their disadvantage is can use at home is shown in Fig. 7.3. However, the
that they do not provide information about the numerical rating scales mentioned above are most
onset and peak of the analgesic effect. If onset or popular for clinical purposes in North America.
Please fill in this chart each evening before going to bed. Record your pain intensity and the amount of pain relief.
If you have had any side-effects please note them in the side-effects box.
Date
severe
Pain intensity
How bad has moderate
your pain been
today? mild
none
complete
Pain relief
How much pain good
relief have the
moderate
tablets given
today? slight
none
Side effects
Has the treatment upset
you in any way?
How effective was the treatment this week? poor fair good very good excellent Please circle your choice
References 69
measuring clinically important patient relevant McQuay, H. J., Carroll, D., and Moore, R. A. (1988):
outcomes to antirheumatic drug therapy in Postoperative orthopaedic pain the effect of
patients with osteoarthritis of the hip or knee. opiate premedication and local anaesthetic
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Burford Nursing Development Unit (1984): Nurses and Melzack, R. (1975): The McGill pain questionnaire:
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measure of analgesia for mega-trials: is a single language of pain. Anesthesiology 34, 509.
global assessment good enough? Pain 91, 18994. Moore, R. A., Paterson, G. M., Bullingham, R. E.,
Farrar, J. T., Young, J. P., LaMoreaux, L., Werth, J. L., Allen, M. C., Baldwin, D., and McQuay, H. J.
and Poole, R. M. (2001): Clinical importance of (1984): Controlled comparison of intrathecal
changes in chronic pain intensity measured on an cinchocaine with intrathecal cinchocaine and
11-point numerical pain rating scale. Pain 94, morphine. Clinical effects and plasma morphine
14958. concentrations. Br J Anaesth 56, 83741.
Follick, M. J., Ahern, D. K., and Laser-Wolston, N. Peloso, P. M., Bellamy, N., Bensen, W., Thomson, G. T.,
(1984): Evaluation of a daily activity diary for Harsanyi, Z., Babul, N., and Darke, A. C.
chronic pain patients. Pain 19, 37382. (2000): Double blind randomized placebo
Gould, T. H., Crosby, D. L., Harmer, M., Lloyd, S. M., control trial of controlled release codeine in the
Lunn, J. N., Rees, G. A. D., Roberts, D. E., and treatment of osteoarthritis of the hip or knee.
Webster, J. A. (1992): Policy for controlling pain J Rheumatol 27, 76471.
after surgery: effect of sequential changes in Rawal, N., and Berggren, L. (1994): Organization of
management. Br Med J 305, 118793. acute pain services: a low-cost model. Pain 57,
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Measurement of health status: ascertaining the Rundshagen, I., Schnabel, K., Standl, S., and Schulte am
minimal clinically important difference. Controlled Esch, J. (1999): Patients vs. nurses assessments
Clinical Trials 10, 40715. of postoperative pain and anxiety during patient-
Jensen, M. P., and McFarland, C. A. (1993): Increasing or nurse-controlled analgesia. Br J Anaesth 82,
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(1985): Reassessment of verbal and visual analogue used to describe pain and analgesia in clinical
ratings in analgesic studies. Clin Pharm Ther 38, trials. Clin Pharm Ther 32, 1418.
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McGrath, P. J., Ritchie, J. A., Unruh, A. M., Carroll, D., Houde, R. W. (1980): Clinical evaluation of mild
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04098-08.qxd 06/02/2004 14:29 PM Page 70
8
Trauma severity indices
Julian P. Cooper
die, and below which all patients survive. The area A frequently quoted measure in the trauma
under the curve is 1 (the maximum possible) in this severity index literature of calibration is the
idealized situation. The centre curve depicts the situ- Hosmer-Lemeshow (H-L) statistic (Hosmer and
ation when there is no discrimination. There is no Lemeshow 1989). The data are grouped into
cut-off that discriminates, and the area under the approximately ten deciles of risk, and the observed
curve is 0.5 the minimum possible. The plot on and expected number of deaths in each decile are
the right illustrates a more realistic situation where compared by calculation of a 2 statistic. The lower
there is good discrimination the area under the the value of the H-L statistic, the closer the observed
curve approaches 1. data fit the prediction. Unfortunately, there are at
least three different methods by which the data can
be grouped into deciles, as pointed out in a study
comparing two measures of trauma severity
Calibration (Hannan et al. 1995). The H-L statistic is also sensi-
tive to the size of the dataset used to derive it the
Logistic regression is a technique for the analysis of larger the dataset, the larger the statistic. For this
dependence of a binary outcome on one or more reason it is important to compare H-L statistics for
predictor variables. In the assessment of trauma scores based on the same underlying dataset.
scoring systems, the binary outcome is usually the
state of being dead or alive, and the predictor vari-
able the probability of death. Logistic regression is SCORING SYSTEMS
analogous to generalized linear regression, which
analyses the corresponding analysis for normally Anatomical scoring systems
distributed outcomes. When analysing the predic-
tions of a trauma scoring system, the agreement THE ABBREVIATED INJURY SCALE (AIS)
between observed and predicted mortality rates The AIS has received wide acceptance as a tool for
across the range of the score is termed the calibra- describing the severity of a specific injury. The prin-
tion of the score. A trauma severity index can be a ciple of this scale was established in 1971
mathematical model of the probability of death (Committee on Medical Aspects of Automotive
based on various anatomical and physiological Safety 1971), and a manual rating a wide range
parameters, and the calibration of this model meas- of blunt injuries was published five years later.
ures how well the score represents reality. This manual is in its 1990 revision (Committee on
04098-08.qxd 06/02/2004 14:29 PM Page 73
Scoring Systems 73
Injury Scaling 1990) and now includes penetrating inevitable and performance shows generally poorer
trauma. Each injury has been classified by commit- discrimination and calibration than conventionally
tee into a six-point scale. An injury with an AIS scored measures (Sacco et al. 1999).
of 1 is classified as minor, while an unsurvivable
injury receives a classification of 6. A critical injury, INJURY SEVERITY SCORE (ISS)
with a score of 5, is of the level of severity of com- The ISS (Baker et al. 1974) was developed as a
plete abdominal aorta transection. means by which AIS scores could be combined to
A number of criticisms can be levelled at such a provide a means of characterizing polytrauma and
system. The scoring is based on the consensus of a of examining the standard of care in trauma insti-
committee of experts in trauma, rather than directly tutions. The ISS divides the body into six regions:
upon patient outcome data (Osler et al. 1996). In
any particular patient an injury may carry different 1. Head and neck
significance, because of co-morbidity, or the pres- 2. Face
ence of other injuries. Although the scale is ordered,
it is not linear and hence simple combination of 3. Chest
scores is not valid in the multiply injured patient. 4. Abdomen
This latter problem led to the formulation of the
Injury Severity Score (ISS) (Baker et al. 1974) (see 5. Extremities including bony pelvis
below). In a theoretical study (Rutledge 1996) aimed 6. Integument
at the ISS, but in fact criticising by implication the
AIS and other scores based upon it, Rutledge sug- To derive the ISS, the AIS scores for all injuries in
gested that AIS scores might be exaggerated by mis- the patient are first collected. The highest AIS
management of patients. An example given in the scores in each region are then selected and, of these,
study was of a cervical spine fracture without cord the three most severe are combined to give the
injury (AIS 2; ISS 4) becoming as severe as a ISS by adding their squares. The AIS scores of all
patient with a well-managed complete cord injury other injuries, however severe, are discarded. For
(AIS 5; ISS 25) if the lesser injury had been example, a score of 4 for Head and Neck, 2 for
missed and not immobilized. No patient-based stud- Chest, 5 for Abdomen and 3 for Extremities
ies have been published to confirm or refute this would equate to an ISS of:
hypothetical problem, but this highlights a poten-
tial pitfall in interpretation of scores based upon 42 52 32 50
AIS. Furthermore, scores might not be comparable
between body regions: for example, an injury with For this reason, a patient with a pelvic ring fracture
a Head and Neck score of 5 is likely to carry a and several long bone fractures will receive the
worse prognosis than an Abdomen score of 5. same Extremities contribution to their overall ISS
Use of the AIS requires detailed examination of as a patient with the worst of these individual
case records, and comparison with the current AIS injuries and no others within that body region. Of
manual to determine the appropriate score. This is course, if a patient has worse injuries in three other
time consuming and will not be possible in epi- body regions, then these extremity scores will also
demiological studies where individual case records be discarded. By convention, any patient with an
are not available. Many units record discharge diag- AIS of 6 in any single body region receives a total
noses as International Classification of Disease diag- score of 75, irrespective of their other injuries.
nostic codes, and attempts have been made to map Apart from the loss of information and potential
these to AIS body regions and scores (Mackenzie predictive value inherent in discarding data, there is
et al. 1989). This may allow calculation of AIS-based a further potential problem with the ISS owing to the
scores for population studies, but inaccuracies are lack of consistency of AIS scores across different
04098-08.qxd 06/02/2004 14:29 PM Page 74
jn
ICISS SRR j
PHYSIOLOGICAL SCORING
j1 SYSTEMS
n total number of injuries
The prototype physiological score was the Glasgow
SRRj SRR of injury j
Coma Scale (Teasdale and Jennett 1974); this was a
This method of calculation was originally used for simple, easily reproducible score which aided man-
the RESP (Revised Estimated Survival Probability) agement, albeit in one system. The development of
index described in 1982 (Levy et al. 1982). The physiological indices of trauma severity started
RESP index was also based on the International with measures of simple parameters in a similar
Classification of Disease of the day, but had survival way to the GCS.
probabilities assigned rather than derived from data.
The ICISS should also not be confused with AIS and
ISS ratings based on mapping (Mackenzie et al. The Trauma Score (TS) and Revised
1989) the AIS definitions to ICD codes. Trauma Score (RTS)
ICISS can also be used to predict outcome and
resource utilization (Osler et al. 1998; Rutledge and The TS (Champion et al. 1981) was one of the
Osler 1998) for disease in general, by extension of first useful physiological scores, and was used as a
the underlying registry data to include all ICD diag- triage tool in the United States. Rapid assessment is
noses. Somewhat confusingly, the abbreviation possible as five simple parameters are measured:
ICISS (for ICD-9-based Illness Severity Score) is
used to refer to this broader severity index as well 1. GCS
as the trauma-based score.
2. Systolic blood pressure
The ICISS has been found to outperform ISS
(Rutledge et al. 1998; Sacco et al. 1999) and TRISS 3. Capillary return
(Rutledge et al. 1998) as a trauma severity score, but
4. Respiratory rate
there are differences in calibration and performance
according to which underlying trauma registry is 5. Respiratory effort
04098-08.qxd 06/02/2004 14:29 PM Page 76
1
Ps
1 eb
THE ACUTE PHYSIOLOGY AND
CHRONIC HEALTH EVALUATION
The parameter b is calculated from the RTS, ISS
(APACHE) SCORES and age using the following form of equation:
The APACHE scoring system was originally
described in 1981 (Knaus et al. 1981), and has been b b0 b1 (RTS) b2 (ISS) b3 (Age)
revised successively to APACHE III. Its main role
has been in the assessment and monitoring of The individual coefficients b0, b1, b3 are derived
patients on intensive care units (ICU). Victims of from logistic regression analysis of the trauma
polytrauma are often treated on ICUs, and the scale registry outcome data, and when combined into
has been used in assessment of injury severity. It is the equation for Ps produce a probability of sur-
somewhat more complex than the RTS to calcu- vival figure which represents a population proba-
late; APACHE III requires knowledge of 18 physio- bility rather than the individual chance of survival.
logical parameters. One major difference from A Ps of 0.75 represents the chance that 75 per cent
other measures is the Chronic Health portion of of patients presenting with these parameters will
the score, which takes into account co-morbidities. survive not that an individual patient would have
In trauma patients the presence of co-morbidities a 75 per cent chance of survival. The derivation of
undoubtedly influences outcome (Sacco et al. the coefficients depends on the relevance and quality
1993), but the incidence of these conditions is rela- of the underlying trauma registry. In particular there
tively low. Comparisons of APACHE II with TRISS are significant differences in case-mix between the
(Wong et al. 1996), TS and ISS (Rutledge et al. United Kingdom and the United States, such that
1993) have demonstrated that the APACHE system use of American TRISS coefficients would lead to
04098-08.qxd 06/02/2004 14:29 PM Page 77
NEW CONCEPTS
The A, B and C parameters refer to the components
of the Anatomic Profile (Copes et al. 1990), and
hence the individualized coefficients derived from a
Artificial neural networks
trauma database should be able to model the influ-
ence of structural injury more closely than is pos- From the foregoing discussion of trauma scoring it
sible with the single ISS component of TRISS. is apparent that many parameters need to be taken
ASCOT has been compared with TRISS using into account in developing a model of outcome in
MTOS- (Champion et al. 1996) and non-MTOS- the trauma victim. Recently, several studies (Rutledge
(Hannan et al. 1995) derived coefficients and, et al. 1998; DiRusso et al. 2000; Becalick and
broadly, ASCOT performed better. Despite its supe- Coats 2001) have examined the use of Artificial
rior performance the question remains as to whether Intelligence (AI) techniques to improve the model-
it is justified to change methodologies before an ling of many predictor variables. The AI technique
alternative to TRISS with considerably greater pre- of the artificial neural net (ANN) shows promise
dictive power is developed. for developing a model with improved calibration.
These mathematical techniques are designed to mimic
the arrangement of interconnections in an animal
nervous system. These systems can demonstrate
PAEDIATRIC TRAUMA SEVERITY high performance in otherwise unsatisfactory cir-
cumstances working with incomplete data to pro-
The scores mentioned so far have been developed duce useful output. These techniques may have
in adult patients. Attempts to apply physiological many applications in medicine, but are currently in
scores to children are prone to difficulties owing to their infancy. One study in particular (DiRusso
varying normal ranges with age. The Pediatric et al. 2000) showed extremely good calibration,
Trauma Score (PTS) (Tepas et al. 1987) includes a and the area clearly shows promise.
parameter related to the weight of a child and util-
izes ranges of systolic blood pressure appropriate
to children. In comparing various trauma scoring
systems, one study (Yian et al. 2000) has found CONCLUSION
that outcome was better correlated with TRISS and
the Trauma Score rather than the specific PTS. It There is currently a plethora of trauma severity
should be noted that this study only looked at indices and evidence about their relative efficacy.
orthopaedic polytrauma, and in general one should Many more have fallen by the wayside over the
use caution when drawing conclusions about out- years. It is clear that improving outcome predic-
come predictions for a subset of the trauma popu- tion, both in discrimination and in calibration is
lation. The difficulties in the paediatric field are needed, but work towards this often appears unco-
illustrated by a recent study, which could not demon- ordinated. While TRISS remains the most widely
strate any superiority of the NISS over the ISS in used outcome prediction methodology, work
children (Grisoni et al. 2001) for the prediction of examining alternatives to the ISS, such as ICISS
mortality. The originator of the PTS has introduced or NISS, appears unlikely to result in ISS-based
a combined index for children, the Pediatric Risk measures being supplanted.
04098-08.qxd 06/02/2004 14:29 PM Page 79
References 79
9
Complications
Alasdair J. A. Santini and Simon P. Frostick
82 Complications
complications, discuss the severity of complications A further term that is gaining popularity, par-
and touch on a number of specific complications. ticularly in the North American literature, is
co-morbiditor. This is defined as a co-existent active
medical or operative problem (Liang et al. 1991). A
co-morbiditor may or may not modify the outcome
DEFINITIONS
of a procedure. In the context of this chapter, the
If accurate and universally accepted definitions of term co-morbiditor will be used to refer to condi-
what does and does not constitute a complication tions such as diabetes or rheumatoid arthritis, which
are not used, problems can occur. Clinicians may be may increase the risk of complications associated
reasonably happy with their own definitions but with an orthopaedic procedure such as a wound
these may not be what other clinicians accept as a infection. They may in themselves result in an adverse
definition. Many define a complication as any event event because the condition has been modified as a
occurring during the course of treatment which result of the stress of an anaesthesia or orthopaedic
results in some retardation or alteration of recovery procedure.
from the norm. Thus, a complication may arise from We will use the term complication as a generic
a pre-existing disease in the patient or as a direct term for all adverse events in a treatment episode,
result of a treatment programme. and divide into those attributable to a pre-existing
The other potential problem with terminology lies disease and those arising as a direct consequence
with the term complicated rather than complica- of an orthopaedic intervention. Conventionally,
tion. The general public may have a different view complications have been divided into major and
of a complicated illness than that of a clinician. A minor. Whilst clinicians may agree among them-
complex injury, in an orthopaedic setting, may be a selves what is major and minor, this may not neces-
communited or an intra-articular fracture. This sarily be in agreement with the patient the very
may heal without significant problems that is, there person who has the complication. The distinction
are no complications. Most people in the street, between a major and minor complication is a very
however, would regard this as being a complicated difficult one, and in general will depend on a num-
fracture. This problem is reflected in dictionary ber of factors such as the general health status of
definitions. For example, Butterworths Medical Dic- the patient, the severity of the complication itself
tionary (Second Edition) defines complications as: and the ease of the diagnosis. Here, a major com-
plication is defined as any complication which causes
1. The co-existence in a patient of two or more a prolongation of admission, results in a further
separate diseases. operative procedure or is potentially or actually
2. Any disease or condition that is co-existent with life-threatening.
or modifies the course of the primary disease but
need not be connected with it.
Recording Complications 83
Table 9.1: Suggested categories of complications Table 9.2: American Society of Anesthesiologists Classification
of physical status. Any patients in any of the groups who are
operated on in an emergency are deemed to be in a poorer state
Elective orthopaedics Trauma
and are pre-fixed by the letter E
84 Complications
Specific Complications 85
86 Complications
of tissue, especially those around implants and (Murray et al. 1995), which is an order of magni-
fractures. Many publications (Benson and Hughes tude less than previously held views. With these
1975; Nelson et al. 1980; Lidwell et al. 1982; small numbers, there are few clinical trials in
Salvati et al. 1982; Gristina and Kolkin 1983) have orthopaedic surgery that conclusively demonstrate
demonstrated the serious problems of infection fol- a significant reduction of PE with any regimen of
lowing total joint replacement, and have also dis- prophylaxis; such a trial has been calculated to
cussed the contribution of prophylactic antibiotics, require between 20 000 and 100 000 patients
special theatres and appropriate clothing in reducing (Gillespie et al. 2000). The recent PEP trial
infections. Despite this, Wilson (1987) suggested recruited over 13 000 patients and concluded that
that only about one-third of surgeons used antibi- compared with placebo, aspirin produced signifi-
otic regimen of appropriate duration and timing in cant reductions in total thromboembolism, total
patients undergoing total hip replacement or other PE, fatal PE and DVT. The absolute figures showed
implant surgery. a reduction in total thromboembolism from 2.5 per
It is uncommon for surgeons to score wound cent to 1.6 per cent and fatal PE from 0.6 per cent
problems and use these data as a possible predictor to 0.3 per cent. This equates to treating 250
of outcome. Peel and Taylor (1991) suggested that patients to prevent one death from a fatal PE (The
all surgical specialities use the scoring system known Pulmonary Embolism Prevention (PEP) Trial
as ASEPSIS (Wilson et al. 1986) for the assessment 2000). The interpretation of the PEP trial results
of wounds as shown in Table 9.4. This is a general are open to criticism. The PEP trial did not show a
scoring system; not all categories apply to everyday reduction in total mortality which was the primary
orthopaedic practice and some may be difficult to end-point according to the protocol. Further, there
assess. Nevertheless, this type of system may be was a statistically significant increase in bleeding in
useful if adapted specifically to orthopaedic prac- the aspirin group. Finally, aspirin had no effect
tice, providing there was full validation. whatsoever in the lower-limb arthroplasty group.
Since it is difficult to study accurately the principal
outcome, another outcome must be used and this
Thromboembolism tends to be the rate of DVT. This condition is a pre-
requisite for PE in the vast majority of cases, but
Thromboembolic complications are common in not all DVTs predispose to PE. Minor calf vein
both elective and trauma orthopaedic practice. In thromboses are clinically insignificant and tend to
total hip and knee replacement surgery, many stud- disperse; thus, an outcome measure that emphasizes
ies have found the rate of DVT to be greater than these is likely to be clinically inappropriate. Clinical
50 per cent. Similar figures have been produced detection of DVT is a useless outcome measure
for major fractures (Gillespie et al. 2000; Sagar (Gallus et al. 1976). Some 50 per cent of legs that
et al. 1976). are symptomatic enough to warrant further investi-
There is continued debate in orthopaedic circles gation have no thrombosis, whilst a further 50 per
regarding acceptable prophylaxis regimens. How- cent of all thromboses are asymptomatic.
ever, measurable rates of DVT and PE still occur The options for investigation of DVTs are numer-
without changes on practice. This is because the ous. Many studies have used radio-labelled fibrino-
outcome measures used in clinical trials, which are gen uptake (RFUT) as an initial outcome measure
selected in order to let those trials achieve statistical or selection criterion for venography. This is inap-
significance, are not the same as the outcomes that propriate for hip surgery, for two reasons. First,
concern the surgeon. because the surgery itself increases uptake in the
The principal outcome in thromboembolic disease thigh; and second, because unlike the situation
is fatal PE. The reported prevalence of this is cur- in general surgery the phenomenon of isolated
rently around one or two per 1000 operations proximal thrombosis is responsible for around
04098-09.qxd 06/02/2004 14:30 PM Page 87
Specific Complications 87
Table 9.4: ASEPSIS scoring for wound infections. Adapted from Peel and Taylor (1991)
Table A
Percentage of wounds
Serous exudate 0 1 2 3 4 5
Erythema 0 1 2 3 4 5
Purulent exudate 0 2 4 6 8 10
Separation of deep tissues 0 2 4 6 8 10
Table B
Criterion Points
Additional treatments
Antibiotics 10
Drainage of pus (LA) 5
Dbridement of wound (GA) 10
Serous discharge* Daily 05 (from Table A)
Erythema* Daily 05 (from Table A)
Purulent exudate* Daily 010 (from Table A)
Separation of deep tissues* Daily 010 (from Table A)
Isolation of bacteria 10
In-patient stay 14 days 5
25 per cent of all thromboses (Stamatakis et al. et al. 1990). Compression ultrasound is becoming
1977). the investigation of choice with a high reliability
Ultrasonography in various forms has been utilized if repeated twice, seven days apart (Chunilal and
frequently in the detection of DVTs. Recent studies Ginsberg 2000).
on real-time ultrasound have been most encour- Venography is frequently described as the gold
aging, showing excellent sensitivity and specificity standard for thrombosis detection (Bettman 1987).
for all but the smallest distal thromboses (Prandoni Its drawbacks are that it is invasive, expensive, mildly
04098-09.qxd 06/02/2004 14:30 PM Page 88
88 Complications
thrombogenic, and capable of causing allergic reac- average time for development of symptoms of 27
tions. In clinical practice, venography is sometimes days after THR and 16 days after TKR. In add-
used routinely 714 days after high-risk surgery, ition, 50 per cent of the late DVTs after both THR
but more frequently (in the UK) only when indi- and TKR are proximal. As far as TKR patients are
cated by symptoms. Realistically, it cannot be used concerned, this is a much higher proximal DVT
repeatedly and thus only gives a single-frame view rate than is found in clinical trials. The increase could
of the venous system. Nevertheless, this investiga- be due to de-novo proximal DVT or an extension
tion is at present the single most important measure of an asymptomatic calf DVT.
in both thrombosis research and, to a certain One group (Oishi et al. 1994) studied 273 THR and
extent, in clinical practice. TKR patients. Patients were examined with duplex
Traditionally, thromboprophylaxis has been used ultrasound on the 4th postoperative day. Overall,
only for the in-patient stay following a surgical pro- there was a 9 per cent proximal DVT rate and a 15
cedure. Among orthopaedic surgeons there has been per cent (41 patients) distal calf DVT rate. The
an attitude that venous thromboembolism (VTE) patients with a calf DVT were re-examined on the
is not a problem that they see, the reason being that 7th and 14th post-operative day, and seven proximal
many thromboembolic complications occur once the DVTs were detected by the 14th day. Unfraction-
patient has been discharged from hospital. Recent ated heparin (UH) was the drug of choice in a study
data suggest that there is a significant new DVT by Manganelli et al. (1998). DVT was detected (by
rate occurring up to 35 days after surgery. This is venography) in 16.3 per cent of patients after dis-
an important observation as in-patient stay lengths charge, there were two symptomatic PEs. The
are reducing every year. In the USA, many patients authors state: The incidence of DVT was 21.4% in
are discharged after lower-limb arthroplasty after short- and 12.1% in long-term UH-treated patients.
only four days. The ACCP Guidelines specify a min- The incidence of only proximal DVT was 18.8% in
imum of six days prophylaxis in all orthopaedic short- and 3.0% in long-term UH-treated patients
patients. In the UK, stay lengths for major lower- (p 0.85). Prophylaxis with UH given up to post-
limb arthroplasty ranges from about 7 to 10 days, operative day 30 appears more effective and safer
but this is likely to shorten considerably. in reducing the delayed thromboembolic risk com-
The argument against prolonged prophylaxis is pared to prophylaxis with UH given up to dis-
identical to that used to argue against the use of charge only.
chemical prophylaxis in-hospital that is, the preva- Another group (Planes et al. 1996) performed
lence of clinical VTE events is low after lower-limb venography in a group of THR patients at the time
arthroplasty. This ignores the significance of sub- of discharge and then randomized them to either
clinical events that have been shown to be associ- placebo or enoxaparin for a further 21 days. The
ated with major morbidity and mortality. Recently, authors showed that there was a late occurrence of
however, data have been published reporting the DVT, and that if enoxaparin was continued then the
late symptomatic DVT prevalence after lower-limb risk of distal was significantly reduced. Interestingly,
surgery. The late incidence of clinical DVT in a there was no difference between the groups for prox-
population of 19 586 patients undergoing total hip imal DVT, with a prevalence in the enoxaparin
replacement (THR) was found to be 2.8 per cent, group of 5.9 per cent and in the controls of 7.9 per
and for 24 059 patients undergoing total knee cent. Berqvist and Jonsson (2000) also studied the
replacement (TKR) was 2.1 per cent, at three months use of continued prophylaxis with enoxaparin until
after discharge (White et al. 1998). Dahl et al. day 30 after operation. Patients underwent veno-
(2000) have studied late clinical events in a group graphy between 19 and 23 days after discharge.
of patients that included those undergoing lower- These authors also showed that there was a continu-
limb joint arthroplasty. These authors report an ing risk of VTE after discharge from hospital. If the
annual incidence of DVT of 2.1 per cent with an enoxaparin was given for one month there was a
04098-09.qxd 06/02/2004 14:30 PM Page 89
Specific Complications 89
significant reduction in VTE compared to those who diagnostic test for PE is a ventilation/perfusion (V/Qc)
only received the drug in-hospital. scan, but this is exclusively performed in symp-
Two other groups (Lassen et al. 1998; Dahl et al. tomatic patients except in clinical trials. As most
2000) have also shown that there is a significant patients to whom PE proves fatal, die within 12
occurrence of new DVTs up to 35 days after surgery, hours of the onset of symptoms (Havig 1977), this
substantially after the normal period for in-hospital modality has a rather limited role in the prevention
prophylaxis. of fatal PE. The relationship between asymptomatic
Colwell et al. (1999) compared enoxaparin and PE and subsequent lung function has not been
warfarin in a multicentre study of 3011 THR elucidated.
patients. The enoxaparin was given at 20 mg twice The post-phlebitic limb, as an end-point requires
daily and started within 24 hours after surgery. careful definition, which normally includes oedema,
Warfarin was given from as early as 48 hours varicosities, pigmentation and ulceration. There
pre-operatively and no later than 24 hours post- remains some doubt as to whether proximal valve
operatively. Both drugs were only given while the failure or calf perforator incompetence is the more
patients were in hospital. The patients were clinic- important predisposition to post-phlebitic changes.
ally assessed, and the symptomatic DVT rates were Although prevention of chronic venous disease is
seen to be 3.6 per cent after enoxaparin and 3.7 per part of the rationale for thromboprophylaxis, there
cent after warfarin. In-hospital the rates were: total is no good evidence that asymptomatic thrombi are
1.1 per cent (0.3% enoxaparin; 1.1% warfarin; an important factor in its development (Francis
p 0.0083). After discharge, the rates were: total et al. 1988). The same group reviewed a small num-
4 per cent (warfarin 2.6%, enoxaparin 3.4%; ber of patients who had undergone THR and TKR
p NS). There were four deaths due to PE (two in followed by a post-operative venogram; among 51
each group), and more clinically important bleed- patients seen, many were found to have venous
ing complications occurred in the enoxaparin thrombi and significant evidence of venous insuffi-
group. The authors concluded that enoxaparin ciency, though only one patient was reported as
gave better protection whilst in-hospital, but at having a definite post-phlebitic syndrome. Prandoni
three months there was no difference between the et al. (1997) estimated that at five years after a
treatments. Comp et al. (2001) concluded that proven DVT, some 29.8 per cent of the patients
enoxaparin given for four weeks reduced the risk of had developed a post-thrombotic syndrome. When
VTE without compromising safety. others (Johnson et al. 1995) studied 78 patients with
The second phase of the North American Fragmin acute DVTs, the results showed that only 12 per
Trial (Hull et al. 2000) provides the most recent cent of limbs returned to normal as determined by
and very convincing evidence that dalteparin pro- using duplex ultrasonography. A further 13 per cent
vides significantly better protection against DVT of patients developed skin changes, but 41 per cent
up to 35 days post-operatively as compared with had definite features of post-thrombotic syndrome.
warfarin given in-hospital only. In this study, there Another group (Siragusa et al. 1997) studied patients
were no episodes of major bleeding in the pro- who had undergone THR between two and four
longed phase. These authors showed that pro- years previously. Those patients who had had a post-
longed treatment of only 2428 patients is required operative asymptomatic DVT (46.9%) were stud-
to prevent one out-of-hospital proximal DVT. The ied; 23.9 per cent of them had objective evidence of
study by Hunter et al. (1995) also confirmed that post-thrombotic syndrome, which was comparable
there was a risk of death from PE after stopping with a prevalence of 3.8 per cent in control patients.
in-hospital prophylaxis. Moreover, the authors showed that an asympto-
Pulmonary embolism is under-diagnosed in both matic proximal DVT was the most important risk
routine clinical practice and at post-mortem exam- factor. In a similar study, Ginsberg et al. (2000) sug-
ination (Sandler and Martin 1989). The main gested that post-thrombotic syndrome is extremely
04098-09.qxd 06/02/2004 14:30 PM Page 90
90 Complications
rare after either THR or TKR; there was no difference FRACTURES
between proximal or distal DVT.
In summary, the most feared thromboembolic out- Outcome of treatment of fractures, like other
come is a fatal PE. Using fatal PE as the only end- orthopaedics conditions, will depend upon hospital
point to argue against the use of effective prophylaxis and personnel factors, as well as factors related
is both unreasonable and illogical. A considerable to the fracture itself. Severe fractures, open frac-
body of data obtained from studies of clinical end- tures and multiple trauma are associated with high
points, from clinical trials, and from basic science rates of complications including infection, delayed
support the need for chemical prophylaxis to union and implant failure. A major problem for
reduce the prevalence of all venous thromboem- orthopaedic surgeons has been the comparison of
bolic complications. treatments in ill-defined heterogeneous groups of
fractures. An accepted classification, though com-
plex, is the AO classification of fractures (Muller
IMPLANT PROBLEMS et al. 1987; Colton 1991). When applied correctly,
it is possible to recognize the type of fracture being
Dislocation of a total hip replacement, whether treated. Some injuries have their own specific grad-
during the immediate post-operative period or at a ing systems in common use such as the Schatzker
later date, constitutes a complication of that type of classification for tibial plateau fractures (Schatzker
surgery. Similarly, infection detected soon after sur- et al. 1979) or Gustillo and Andersons classi-
gery and that found months or years later is a com- fication for open tibial fractures (Gustillo and
plication of the original surgery. The need to revise Anderson 1976). Further, an accurate definition of
the joint replacement for these reasons must be associated soft tissue damage is needed to accom-
regarded as a late complication. However, the ques- pany AO classifications. The AO Foundation has
tion remains as to whether the need to revise a total developed a method of coding soft tissue injuries
joint replacement for aseptic loosening be regarded including severity. Again, some specific classifica-
as an operative complication, or whether it reflects tions have been developed for particular fracture
the natural history of bone/cement/metal contact. types, such as Tschernes classification for tibial
If the loosening is due to poor implant design, rather fractures (Tscherne and Gotten 1984). This is of
than surgical technique, then it is a complication great importance as limb trauma is a soft tissue
but not for the surgeon. In this context, the time after injury with an underlying bony fracture. Complica-
surgery and the reason for the revision is important. tions following limb trauma are highly dependent
Early (and the meaning of this needs careful on the state of the soft tissues. Even when classifi-
definition) loosening due to poor cementing tech- cations are used, there may still be disagreement
nique may be regarded as a complication, but other- amongst surgeons. Brumback and Jones (1994)
wise loosening may be regarded as part of the natural asked a number of surgeons at an orthopaedic
history of this type of implant. The revision of an trauma association meeting to classify 12 open
implant because of loosening is frequently used as an tibial fractures using the Gustillo and Anderson
outcome measure in orthopaedics. Survival analysis classification, having given them a clinical history,
of total hip and knee replacements usually depends X-radiograms and an intra-operative view of the
upon the revision rate. However, the main problem is surgical dbridement. There was only a 60 per cent
the ability to diagnose accurately any loosening pros- agreement rate for the 12 fractures.
theses. If revision rate is the outcome measure, this Patients with major trauma often have serious
will mostly be based upon symptomatic loosening, and sometimes fatal complications. This group of
with the real loosening rate probably being higher. patients is an example of the interaction between
The scoring systems available for assessing loosening the three areas discussed above under the title
are discussed in later chapters of this book. severity. Very careful documentation is required
04098-09.qxd 06/02/2004 14:30 PM Page 91
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in order to delineate what are avoidable and what morbidity with adjustment for admission severity.
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Charlson, M. E., Sax, F. L., MacKenzie, C. R.,
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10
Outcome after blast, missile and gunshot wounds
Jonathan C . Clasper
Site of injury Mortality rate (%) Number 255 135 200 238
of cases
Large bowel 6.5 Dead 5 (2.0) 28 (20.7) 38 (19.0) 145 (60.9)
Small bowel 5.6 Major 14 (5.5) 13 (9.6) 38 (19.0) 27 (11.4)
Liver 8.5 injury
Stomach 7.3 Moderate 23 (9.0) 16 (11.9) 35 (17.5) 15 (6.3)
Kidney 7.8 injury
Spleen 4.5 Minor 213 (83.5) 78 (57.8) 89 (44.5) 51 (21.4)
Pancreas 5.7 injury
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Table 10.7: Royal Navy employment grades a paratrooper is likely to be different from that of
an orthopaedic surgeon, despite the same grading of
Grading Comments P2FE. The system does, however, provide a common
language, within the military, which allows medical
P0 Temporary holding category personnel to communicate with front-line command-
ers, to give an indication of an individuals medical
P2 Fit for all duties
fitness.
P3R Fit for sea on ships with medical facilities
restriction to be stated
P7A Not fit for sea, but employable ashore, or
on a ship in harbour in own trade
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P8 Unfit for Naval service Bellamy, R., Champion, H., Mahoney, P., and Roberts, P.
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Table 10.8: Royal Air Force medical grading
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A1 Full flying duties
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Z1 Fit for service anywhere
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zones
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Deformity and cosmesis
T. N. Theologis
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Hanyu, T., Yamazaki, H., Murasawa, A., and Toyama, C. separations. Bull Hosp Joint Dis 56, 7783.
(1997): Arthroplasty for rheumatoid forefoot Prince, F., Winter, D. A., Sjonnensen, G., Powell, C.,
deformities by a shortening oblique osteotomy. and Wheeldon, R. K. (1998): Mechanical
Clin Orthop 338, 1318. efficiency during gait of adults with transtibial
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J. J., and Theologis, T. N. (1999): Magnetic healed lacerations. Am J Emerg Med 13, 22931.
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modelling in cerebral palsy. Gait Posture 10, 845. J., Stiell, I., and Johns, P. (1998): Tissue adhesive
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04098-11.qxd 06/02/2004 14:31 PM Page 112
12
Growth plate injuries
D. M. Eastwood
Fractures in childhood are common. Although the on the physis, the muscles shape the apophysis
physis is the weakest link in the immature skeleton, and the bone itself.
only 18 per cent of bony injuries actually involve the
Histologically, both physes consist of four main lay-
growth plate (Mizuta et al. 1987). Physeal injuries
ers: the germinal layer; the proliferative zone; the
are considered to have a favourable outcome, heal-
hypertrophic zone; and the zone of transformation.
ing quickly and remodelling with time; never-
The perichondrial ring, which is contiguous with
theless, any surgeon involved with such cases is fully
the articular cartilage and receives the metaphyseal
aware that joint incongruity and premature growth
periosteum, surrounds the physis. The ring plays a
arrest do occur. Some authors believe that these
critical role in the structural integrity of the imma-
dreaded complications are predictable and, under
ture bone and, by contributing cells to the germinal
certain circumstances, are preventable (Salter and
layer of the physis, it is partly responsible for lati-
Harris 1963). However, before an outcome can be
tudinal bone growth.
so assured, a sound understanding of the patholog-
The growth plate itself is devoid of vascular chan-
ical anatomy is required.
nels. It receives nutrition from three sources. Epi-
physeal vessels nourish the germinal cells. Damage to
these vessels causes irreparable alteration to the phy-
APPLIED ANATOMY OF seal growth potential. The periosteal vasculature sup-
THE GROWTH PLATE plies the perichondrial ring and the peripheral physis.
The nutrient artery feeds the metaphyseal side of the
The structure and strength of the physis and sur- central 75 per cent of the physis. Vascular damage
rounding tissues change with growth. Similarly, the slows the transformation of cartilage to bone, leading
effects of trauma to this region can and do vary to temporary widening of the affected physis (Ogden
with age. The immature skeleton consists of two et al. 1996).
types of growth plate or physis: The physis interdigitates with the metaphysis,
and the resistance to transverse or shear stresses is
The pressure physis: this lies at right-angles to
enhanced by this increased contact area. Early
the long axis of the bone, joining epiphysis to
descriptions of growth plate injuries included a plane
metaphysis. It is normally subjected to
of cleavage through the junctional zone of the physis
compression forces and is responsible for
where there is chondrocyte hypertrophy. The germi-
longitudinal bone growth.
nal cells responsible for bone growth remained with
The traction physis: this links the apophysis the epiphysis, their fate being decided by the state of
(with its major muscle attachments) to the bone the epiphyseal vasculature. More recent pathological
shaft. It does not usually lie perpendicular to and radiological evidence suggests that in over 50 per
the long axis of the bone. By exerting tension cent of cases the cleavage plane may traverse any
04098-12.qxd 06/02/2004 14:31 PM Page 114
Type IV
ASSESSMENT OF PHYSEAL INJURY
Classification
Several general systems for classifying growth plate
injuries have been proposed. Poland was one of the Type V Type VI
first to propose a classification by defining four broad
categories of separation based on the anatomical
features of injury (cited in Petersen 1996). As radi-
ographic imaging improved, further injury patterns
were identified and modifications to Polands clas-
sification were made.
Aitken (1965) described three fracture types. He
felt that deformity secondary to malunion or growth Figure 12.1 Rangs (1969) modification of the Salter-Harris
disturbance was rare, but emphasized that a com- (1963) classification of epiphyseal injuries. Adapted from
pression injury could lead to major growth problems. Weber (1980).
The system described by Weber (1980) was based
on fracture line propagation and helped the clinician (Fig. 12.2). Six specific fracture types are described,
to distinguish fractures which had a good prognosis five of which corresponded closely to five in the
and could be treated closed, from those with a poorer extended Salter-Harris classification system (Petersen
prognosis that required operative treatment. 1994a, b). The Petersen classification has an anatom-
The Salter-Harris (Salter and Harris 1963) classi- ical basis depicting physeal injury as a continuum
fication has gained the most widespread acceptance from relatively minor involvement of the physis
(Fig. 12.1). This system is based on the mechanism (type I) through complete transphyseal involvement
of injury, the relationship of the fracture line to the (type III) to longitudinal disruption of the physis
germinal cells of the physis and outcome as regards with or without loss of a fragment of physeal plate
growth disturbance. In general, fracture types I, II, (types V or VI). This concept of progressive physeal
and III had a good prognosis for growth, whilst damage led Petersen (1994a) to subdivide the type
types IV and V did not. Rang (cited in Weber 1980) II injury depending on the size of the metaphyseal
extended the Salter-Harris classification by describ- fragment. The larger the fragment, the less the
ing a type VI injury with localized damage to the physeal damage.
perichondrial ring and a significant risk of growth Both the Salter-Harris (Salter and Harris 1963) and
disturbance (Fig. 12.1). the Petersen (1994b) systems are concise and are use-
Most recently, Petersen et al. (1994) developed a ful clinically. However, certain injury patterns such as
classification based on an epidemiological review the distal tibial triplane fracture are still not readily
of almost 1000 injuries over a 10-year period accommodated by such systems. Ogden (1981)
04098-12.qxd 06/02/2004 14:31 PM Page 115
IA IB IC
I II III
Metaphysis Metaphysis Physis
physis and physis
IIA IIB IIC IID
IV V VI
Epiphysis Metaphysis, physis Physis
and physis and epiphysis missing
Figure 12.2 Petersens (1994b) classification of physeal injuries. IVA IVB IVC
Symptoms
Malunion
Few published data exist on the subject of symptoms
There are no generally accepted criteria for measur- following skeletal injury in children, and the evidence
ing the cosmetic, functional or psychological effects to support any objective assessment of such symp-
of residual deformity. In the child, functional hin- toms is sparse. Pain assessment in children has been
drance following malunion is rare; minor angulatory documented (McGrath 1989; McGrath et al. 1986),
deformity should remodel with growth, provided but evaluating persistent discomfort as distinct from
that the growth plate has not been damaged. Angular pain is more difficult (c.f. Chapter 7). A review of
deformity in excess of 20 will probably not cor- 281 wrist injuries by Fodden (1992) showed that at
rect, especially if the angulation is not in the axis three years after injury, seven patients complained of
of movement of the adjacent joint (Evans 1990). symptoms such as aching, crepitus and weakness. In
Similarly, rotational abnormalities do not correct this study, all three patients with premature physeal
spontaneously. Remodelling is not a reliable phe- fusion were symptomatic, although only one patient
nomenon and there must be at least two years of had a recognized physeal injury. In contrast, in a
growth remaining (estimated by skeletal age rather study of distal ulnar physeal injuries the majority of
than chronological age) if significant correction is patients were asymptomatic, even with significant
to be achieved (Ogden et al. 1996). Radiographic growth arrest (Golz et al. 1991). It seems unlikely that
evaluation of deformity may be useful in an indi- the presence or absence of symptoms could be used as
vidual case to assess progress with time, but as an anything more than a very general measure of out-
outcome measure it is impracticable. The deformity come. Complex regional pain syndromes are infre-
is rarely maximal in the standard radiographic quent in childhood, and trauma is the precipitating
planes and is essentially unique to each case. factor in only 50 per cent of cases.
Joint incongruity may complicate physeal injuries
that involve the articular surface. It will not remodel
with time and indeed may progress if growth has
been disrupted. The development of osteoarthritis, LATE ASSESSMENT OF OUTCOME
secondary to joint incongruity, may be used as an
Skeletal injury in childhood, particularly when the
outcome measure for growth plate injuries. Very few
physis is involved, may result in disturbance of the
long-term follow-up studies of growth plate injuries
growth mechanism. In this respect, the outcome fol-
addressing this issue have been conducted, and most
lowing fracture differs considerably from injuries in
of these reports have many deficiencies (Caterini
adults, and hence a unique form of measurement is
et al. 1991a, b).
required.
Joint movement
Growth disturbance
Joint stiffness is an important outcome measure fol-
lowing adult trauma. In the child, post-traumatic The most feared (but uncommon) outcome of phy-
stiffness is uncommon unless there is direct damage seal injury is growth retardation with formation
04098-12.qxd 06/02/2004 14:31 PM Page 118
HARRIS LINES
These metaphyseal lines (Harris 1926) often appear
after trauma (Siffert and Katz 1983; Ogden 1984). A Classification of growth arrest
line parallel to the physeal contour indicates that
bone growth has resumed and the risk of significant The following classification system relates growth
physeal damage is minimal. If the lines are present in arrest to outcome and treatment options.
both limbs, the rates of growth can be compared and
matched with expected growth rates. If the metaphy- COMPLETE GROWTH ARREST
seal line and the physis converge, then eccentric phy-
Complete growth arrest is uncommon, but it usually
seal damage has occurred and a bony bar or physeal
leads to a progressive limb length discrepancy
bridge has formed. Harris lines are most obvious in
(Shapiro 1982). The clinical effect of this depends on
regions of rapid growth such as the distal femur and
the age at which the arrest occurs, the growth poten-
the proximal tibia, but are of doubtful value as an
tial of the particular physis involved, and whether the
outcome measure. In fact, they are much less visible
involved bone is part of a paired unit. There are some
in areas of slow growth, except for specific injuries
suggestions that loss of growth from one physis will
about the knee and perhaps the ankle. The resolution
be partially compensated for by accelerated growth
and visualization of arrest lines is significantly better
from the plate at the opposite end of the bone
on MRI than on plain films (Futami et al. 2000).
(Petersen 1996). Shapiros study (Shapiro 1982) has
It is important to identify growth arrest early. If
clearly shown that no such tendency occurs.
plain radiographs leave any doubt as to whether or
not physeal damage exists, then additional imaging
techniques should be employed. In order to plan fur- PARTIAL GROWTH ARREST
ther treatment appropriately, a map of the location, Partial growth arrest with bone bridge formation
size and contour of the bar must be made (Carlson is more common. The size and location of the phy-
and Wenger 1984). Traditionally, this has been seal tether determine the clinical deformity, while
04098-12.qxd 06/02/2004 14:31 PM Page 119
Cross-
Linear: this subgroup is secondary to a malunion
section Cross-section of the Petersen type IV or V (Salter-Harris III or
through physis IV) fracture, and again is associated with
incongruity of the articular margin.
Physis
Occasionally, small bone tethers may be overcome by
Bony bridge
the forces within the physis, but once a substantial
Physis tether has developed, then the progression of defor-
A B C D
mity has an almost linear relationship with time
(Osterman 1972). If damage occurs when the ossi-
(c)
fication centre is very small, the bone bridge may not
Fracture
plane Physis form until the ossific nucleus expands to oppose the
area of physeal damage. In such instances, there
Bony will be a considerable delay before radiological or
bridge
clinical deformity is apparent. However, it may then
Physis progress rapidly. Bony bars occupying more than
50 per cent of the physis are not usually amenable
to surgical intervention (Petersen 1996).
Intra-articular step-off Bony bridge
Although growth retardation following physeal
Bony bridge injury causes most concern, growth acceleration may
Physis
also occur. A fracture adjacent to a physis is known
A B C D to stimulate growth (Shapiro 1981; Taylor et al.
Figure 12.4 Types of partial growth arrest. (a) Peripheral; 1987), although the effect is usually only detectable
(b) central; and (c) linear. Adapted from Petersen (1996). for the first year post-injury. Physeal injury itself may
accelerate growth, but the hyperaemic response to
injury is short as is the subsequent growth dis-
the age at injury and potential growth remaining turbance and the result is rarely of clinical sig-
define the ultimate severity. Both Bright and Ogden nificance. Metallic implants used in the internal
have classified partial growth arrests into three fixation of some fractures act as a chronic stimulus
types. Unfortunately, they used the numbers 1 to 3 for accelerated longitudinal growth in experimen-
in opposite directions (Petersen 1996) (Fig. 12.4). tal animals (Wilson 1970; Castle 1971), but the rel-
It is preferable therefore to use the following evance of this in man has not been addressed fully.
04098-12.qxd 06/02/2004 14:31 PM Page 120
VARIABLES THAT MAY AFFECT the younger child (Riseborough et al. 1983). Consi-
OUTCOME derable force is required to fracture physes such as
those of the distal ulna and metacarpal heads, and
The measures discussed above assess early and late this may account for the high incidence of growth
outcome following physeal injury. However, the disturbance (Golz et al. 1991; Light and Ogden
outcome of any individual injury is highly dependent 1987). On occasion, the applied force is sufficient
on a number of variables. to cause physeal damage without disrupting the
periosteum. A history of a glancing blow to a sub-
cutaneous physis such as that of the distal tibia may
Severity of injury increase suspicion of a perichondrial injury and
encourage patient follow-up. Similarly, repetitive
Overall, as with all injuries, the more severe the dam- application of subcritical forces may result in fatigue
age the poorer the outcome. In the commonly used failure of the physis (Caine et al. 1997).
classification systems, injuries associated with an
open wound, significant soft tissue damage or com-
minution are associated with ascending fracture type Age
and are more likely to be complicated by infection or
bone bridge formation. Fracture outcome is often
The younger the child is when the growth plate
related to initial displacement thus, the greater the
injury occurs, the greater is the potential effect of the
initial displacement the worse the eventual outcome,
injury on growth. However, the peak age for physeal
even if the reduction is satisfactory, though with
injury is 12 years, and by this age many physes have
respect to physeal injuries few data exist to support
only a limited growth potential. The fracture types
such beliefs. One report commenting on injuries to
most associated with growth disturbance are more
the proximal femur considered that the severity of
common in the adolescent patient (Petersen et al.
the initial displacement was of more prognostic
1994). The size of the physis, its contour and its rate
value in children and adolescents than in infants
of growth all change with increasing age, and each
(Caterini et al. 1991a). Certainly, in injuries involv-
of these factors may influence outcome. The size of
ing intra-articular epiphyses, severe displacement is
the growth arrest does not increase with time, but
associated with a high risk of avascular necrosis
the size of the unaffected physis does; thus, a growth
and growth plate arrest (Dale and Harris 1958).
arrest affecting 50 per cent of the physis of a two-
year-old child will represent a smaller proportion of
the physis in the same child aged 10 years.
Mechanism of injury
Whilst the Salter-Harris classification (Salter and
Harris 1963) was based partially on mechanism of Site
injury and detailed the shearing, avulsion, splitting
and crushing elements which could affect the physis, Extra-articular epiphyses derive their blood supply
an understanding of the degree of force applied and from soft tissue attachments remote from the physis,
how the growing skeleton reacts to it is also required whilst intra-articular epiphyses such as those of the
(Riseborough et al. 1983). In the adolescent age proximal femur and the proximal radius are sup-
group the periosteal/perichondrial sheath, in thick- plied by vessels arising from the periosteal vascula-
ness and in strength, resembles that of the adult, and ture which penetrate the periphery of the physis (Dale
the force required to disrupt the physis is relatively and Harris 1958). These vessels are often damaged
less than that needed to rupture the thicker sheath in when epiphyseal displacement occurs, and growth
04098-12.qxd 06/02/2004 14:31 PM Page 121
disturbance is more common when this type of physis Petersen Type II (Salter-Harris Type II):
is injured. Classically, this is the most common type of
The growth potential of physes vary considerably; physeal injury identified, and accounts for
thus, 70 per cent of femoral length arises from the 5375 per cent of cases (Rogers 1970; Oh et al.
distal physis, whereas 80 per cent of humeral length 1974; Petersen 1994b). It is considered a safe
derives from the proximal physis. Injuries to the physeal injury, and reduction is usually both
proximal tibia and distal femur represent only easy to obtain and maintain. However,
3 per cent of injuries (Petersen 1996; Ogden 1981), increasingly, complications have been
but they are among the sites most frequently com- recognized (Light and Ogden 1987; Fodden
plicated by physeal arrest and significant clinical 1992), particularly in the irregular physes
problems. The distal radius is the most frequently (Riseborough et al. 1983; Berson et al. 2000;
injured physis and yet growth disturbance at this Jaramillo et al. 2000).
site has been regarded as extremely uncommon.
Recent studies, however, suggest that if these injuries Petersen Type III (Salter-Harris Type I): This
injury accounts for between 6 and 26 per cent
are followed closely to maturity and their outcome
of cases (Rogers 1970; Oh et al. 1974) and is
evaluated carefully, a higher incidence of problems
truly a fracture through cartilage alone. If the
such as a change in ulnar variance may be identified
plane of cleavage is through the junctional zone
(Golz et al. 1991; Fodden 1992). Physeal damage
of the physis, the outcome should be excellent
leading to limb-length discrepancy is more likely to
unless the epiphysis is intra-articular. It
be of clinical significance in the lower limb than the
commonly occurs as a birth injury or in the
upper limb.
younger child, and is frequently over-diagnosed
Certain physes are subjected to particular stresses
on assessment of a tender lateral malleolus
and develop an undulating structure. Fracture lines
(Petersen 1994b; Lohman et al. 2001).
through these physes are more likely to cross through
various layers of the plate, increasing the risk of dam- Petersen Type IV (Salter-Harris Type III): This
age to the germinal cell layer (Jaramillo et al. 2000; fracture accounts for 610 per cent of cases
Alexander 1976). (Rogers 1970; Mizuta et al. 1987), most
commonly towards the end of growth. In order
to re-establish joint congruity an operative
approach is often needed. The outcome will be
Fracture type good, assuming that the physis is not further
damaged or rendered avascular by soft tissue
Many fracture classifications have attempted to link
stripping during surgery. Growth arrest is
outcome with fracture type and although popular,
common, but usually complete.
the Salter-Harris system (Salter and Harris 1963)
has been only partially successful in this respect. Petersen Type V (Salter-Harris Type IV):
Petersens classification (Petersen 1994b) is more Between 6 and 10 per cent of fractures fall
useful, with both the need for immediate and delayed into this category (Mizuta et al. 1987; Petersen
surgery increasing with increasing physeal damage 1994b). Fractures are frequently comminuted
and ascending fracture type: and often open. Premature growth arrest is
common (partial, linear), even when an open
Petersen Type I: Essentially a metaphyseal
approach has achieved an anatomical
fracture with extension towards the physis. The
reduction.
obvious damage to the physis is minimal. It is
usually due to compression forces and Petersen Type VI (Salter-Harris Type VI):
premature physeal closure has been noted. These rare injuries are often open. If a part is
04098-12.qxd 06/02/2004 14:31 PM Page 122
References 123
Formal grading of muscle strength could be used as surgery performed (Lee et al. 1998; Foster et al.
an objective measure of outcome in both the short- 2000).
and long-term follow-up of apophyseal injuries. An
alternative outcome measure is physeal arrest.
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Volume 3; 4th edition. Lippincott, Philadelphia, Stanley, J. K. (1992): The gymnasts wrist:
pp. 10365. acquired positive ulnar variance following
Petersen, H. A., Madhok, R., Benson, B. A., chronic epiphyseal injury. J Hand Surg 17,
Ilstrup, D. M., and Melton, L. J. (1994): 67881.
04098-12.qxd 06/02/2004 14:31 PM Page 126
13
Peripheral nerve injuries
David Warwick and Peter P. Belward
This is an objective measure of the quality of sen- Protective One point only detected
sation. It is determined by the minimum distance Anaesthetic No point detected
between two points on the skin at which the patient
The test has some advantages, mainly that it is rela-
can distinguish a stimulus. The test is performed as
tively straightforward to perform and can be a use-
follows:
ful screening measure for normal sensation at the
The patient is asked to look away. finger tips. The test correlates moderately well with
the Moberg pick-up test (Chassard et al. 1993).
The ends of a paper clip, a drawing compass or
Notwithstanding imperfect repeatability, it provides
a dedicated wheel can be used.
an objective measure of recovery in neurapraxia
The skin is touched randomly ten times with and low-grade axonotmesis.
both tips, and ten times with one tip (Moberg The test has significant shortcomings, however.
1964, 1990). The force used is critical just less than that needed
to cause blanching beneath the tips, though this is
To pass the test, the patient must score 5 or more, impossible to judge accurately. Too much force may
when the total of incorrect one-point applications cause the pain fibres and/or adjacent tip to be stimu-
is subtracted from the total of correct two-point lated. Repeatability is therefore limited (Bell-Krotoski
applications. A simpler method is for the patient to and Bulford 1988; Bell-Krotoski et al. 1993). The test
correctly state two out of three times whether one is not responsive to change in nerve compression
or two points are being pressed against the skin syndromes (Gelberman et al. 1983). After repair of a
(Omer 1962). The American Society for Surgery divided nerve, the test is not responsive to change and
of the Hand recommends seven correct answers out rarely provides measurable values in adults. Thus,
of ten. two-point discrimination usually remains poor, even
when other measures of sensibility (filament tests
Starting with a distance between the tips of
and tactile gnosis tests) have shown improvement
15 mm, the gap is closed incrementally until the
(Jerosch-Herold 2000; Rosen et al. 2000).
patient fails.
References 133
or in measures of Upper Limb function (e.g. the After nerve repair, even with a satisfactory clinical
Disabilities of the Arm, Shoulder and Hand (DASH) recovery, sensory conduction remains slow and does
Score; Hudak et al. 1996) or Michigan Hand not fully recover (Ballantyne and Campbell 1973).
Outcome Score (Chung et al. 1998) (cf. Chapter 17). Motor recovery is better measured by clinical tests.
Thus, NCS and EMG are of little value in measuring
the outcome after nerve injury.
References 135
repair in a longitudinal cohort. Scand J Plast Tinel, J. (1915): Le signe du fourmillement dans les
Reconst Hand Surg 34, 718. lesions des nerfs peripheriques. Presse Med 47,
Seddon, H. J. (1943): Three types of nerve injury. Brain 3889.
66, 23788. Tubiana, R., Thomine, J. M., and Mackin, E. (1996):
Semmes, J., Weinstein, S., Ghent, L., and Tueber, H. Examination of the Hand and Wrist. 2nd edition.
(1960): Somatosensory Changes after Penetrating E. Martin Dunitz, London.
Brain Wounds in Man. Harvard University Press, von Prince, K., and Butler, B. (1967): Measuring
Cambridge. sensory function of the hand in peripheral nerve
Sunderland, S. (1978): Nerve and Nerve Injuries. injuries. Am J Occup Ther 21, 38596.
Churchill-Livingstone, New York.
04098-14.qxd 07/02/2004 17:40 PM Page 136
14
Spine and spinal cord
Jeremy C . T. Fairbank and Harry Brownlow
DEFORMITY
No satisfactory condition specific assessment for End vertebra
scoliosis has been developed, though the Scoliosis (most tilted)
Cobb angle (in frontal and sagittal planes) (Cobb Outcomes of spinal cord injury depend on clinical
1948). examination and the use of various rehabilitation
outcome measures. The main problem for these
A measure of surface topography (to be defined). patients is the neurological one. The Frankel score
has been used widely and seems robust. It is also
A measure of patient defined outcome (to be
helpful in defining patient groups. In the longer
defined).
term, these patients have diverse problems and out-
comes require careful selection. Non-specific general
LOW BACK PAIN outcome measures such as the Nottingham Health
Profile (NHP) are the most helpful.
There are a large number of measures available to
assess low back pain. We favour the Oswestry
Disability Index for more severe and chronic back
pain conditions, though the Roland-Morris score is Optimum outcome measurements
popular and probably works best in the milder
varieties of back pain as are seen in general practice Frankel Score (Frankel et al. 1969).
or in a primary physiotherapy clinic. Linear analogue
ASIA Revised Motor and Sensory Scoring System
scales are effective for the measurement of pain. (see McGuire 1998).
Generic outcome measures can be used and tend to
correlate with the condition-specific instruments.
They are generally more complex and difficult to
score than either of the suggested outcome scores. INDEX OPERATIONS
Radiographic assessment of fusion status remains
A list is included of recommended index proced-
unreliable.
ures for audit purposes.
CERVICAL SPINE
Lumbar spine (Table 14.2)
Outcome measures for the cervical spine are gener-
ally unsatisfactory, although there is some support Posterior excision of disc prolapse including
for the use of generic outcome measures here. microdiscectomy (lumbar region)
04098-14.qxd 07/02/2004 17:40 PM Page 138
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Visual inspection Cervical range Not tested Youdas et al. Not tested Numerous 4
of motion (1991)*48
Goniometer and Cervical range Alund and Tucci et al. Not tested Numerous 8
electrogoniometer of motion Larsson (1990) (1986); Youdas
et al. (1991)*49
Inclinometer Cervical range Mayer et al. Youdas et al. Not tested Numerous 8
of motion (1993) (1991)
Cervical range of Cervical range Tousignant et al. Ordway et al. Not tested Numerous 8
movement instrument of motion (2000) (1997)
(Youdas et al. 1991)
CMS 50 Ultrasound-based Cervical range Not tested Castro et al. Not tested Not reported 1
spatial kinematic analyser of motion (2000)
(Castro et al. 2000)
CMS 70 Ultrasound- Cervical range Dvir and Dvir and Not tested Not reported 2
based spatial kinematic of motion Prushansky Prushansky
analyser (Dvir and (2000) (2000)
Prushansky 2000)
3-Space computerized Cervical range Ordway et al. Not tested Not tested Not reported 2
tracking system (Tucci of motion (1997)
et al. 1986)
FASTRAK Computerized Cervical range Not tested Jordan et al. Not tested Not reported 0
tracking system (Jordan of motion (2000)*50
et al. 2000)
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Moll technique Thoracolumbar Not tested Merritt et al. (1986) Not tested Numerous 6
(Moll and lateral flexion
Wright 1971)
Photometric Thoracolumbar Not tested Gill et al. (1988) Not tested Not 1
technique flexion reported
(Gill et al.
1988)
Double Thoracolumbar Saur et al. Saur et al. (1996); Not tested Numerous 8
inclinometer flexion (1996) Chen et al.
technique (1997)*18; Stude
(Loebl 1967) et al. (1994)*19;
Williams et al.
(1993)*20; Boline
et al. (1992)*21;
Mayer et al.
(1997)*59; Mayer
et al. (1995)*62
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
CA-6000 Spine motion Dopf et al. Dopf et al. (1994); Not tested Numerous 8
Spine motion (1994); Christensen and
analyser Paquet et al. Nilsson (1998)
(electro- (1991) (cervical spine);
goniometer) Petersen et al.
(1994)
(thoracolumbar);
Paquet et al. (1991)
(thoracolumbar)
Cybex Thoracolumbar Not tested Bo et al. (1997)*22 Not tested Not reported 0
spine motion
Applied Thoracolumbar Not tested Not tested Not tested Hasten et al. 1
Rehabilitation spine motion (1996)
Concepts
(ARCON)
System (Hasten
et al. 1995)
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Scoliometer Rib hump Pearsall et al. Amendt et al. Not tested Karachalios 6
(Bunnell (1992)*7; (1990); Pearsall et al. (1999);
1984) Amendt et al. et al. (1992); Grossman
(1990)*8 Cote et al. (1998); et al. (1995);
Korovessis Dangerfield
and Stamatakis and Denton
(1996); Murrell (1986);
et al. (1993) Samuelsson
and Noren
(1997)
Body contour Rib hump Thurlbourne Pun et al. (1987) Not tested Pun et al. 5
formulator profile and Gillespie (1987)
(Thurlbourne (1976); Pun
and Gillespie et al. (1987)
1976)
Moire fringe Back shape Laulund et al. Pruijs et al. Not tested Adair et al. 0
topography (1982)*1; Adair (1995a)*5 (1977);
(Willner 1979) et al. (1977)*2; Laulund
Nissinen et al. et al. (1982);
(1993)*3; Pruijs Nissinen
et al. (1995a)*4; et al. (1993);
Sahlstrand Pruijs et al.
(1986)*6 (1995a);
Sahlstrand
(1986)
Integrated Shape Back shape Weisz et al. Not tested Weisz et al. Carr et al. 8
Imaging System (1988) (1988); (1991);
(ISIS) (Turner- Jefferson Upadhyay
Smith et al. et al. (1988) et al. (1988);
1988) Hullin et al.
(1991);
Theologis
et al. (1997)
Quantec Spinal Back shape Thometz et al. Not tested Not tested Thometz 2
Imaging System (2000); et al. (2000)
(Wojcik et al. Goldberg et al.
1994) (2001)
Metrecom Back shape Mior et al. Mior et al. Not tested Not reported 0
Skeletal Analysis (1996)*11 (1996)*12
System (MSAS)
(Mior et al. 1996)
04098-14.qxd 07/02/2004 17:40 PM Page 142
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Optoelectronic Trunk Dawson et al. Dawson et al. Not tested Not reported 2
evaluation of deformity (1993) (1993)
trunk shape
(Dawson et al.
1993)
Cobb angle Coronal Pruijs et al. Carman et al. Pruijs et al. Numerous 10
(Cobb 1948) curvature (1995b) (1990); Morrissy (1995b)
et al. (1990);
Goldberg et al.
(1988)
Rib-vertebra Rib inclination Not tested McAlindon and Not tested Numerous 6
angle (Mehta 1972) Kruse (1997)
End vertebra Angle of tilt of Not tested Not tested Not tested Not reported 0
angle (Appelgren end vertebrae
and Willner
1990)
Angle of Scoliosis angle Diab et al. Not tested Not tested Not reported 1
radiographic (1995)
scoliosis (Diab
et al. 1995)
3D Reconstruction Spine and trunk Not tested Labelle et al. Not tested Aubin et al. 3
of radiological deformity (1995) (1997)
deformity
(Dansereau
et al. 1990)
Pearsall et al. (1992)*7 Poor correlation with lumbar Cobb values, OK with thoracic.
Amendt et al. (1990)*8 Poor correlation with lumbar Cobb values, OK with thoracic.
Laulund et al. (1982)*1 High false-positive rate and poor correlation with Cobb angle.
Adair et al. (1977)*2 High false-positive rate and poor correlation with Cobb angle.
Nissinen et al. (1993)*3 High false-positive rate and poor correlation with Cobb angle.
Pruijs et al. (1995a)*4 Poor correlation with Cobb angle.
Sahlstrand (1986)*6 High false-positive rate.
Pruijs et al. (1995a)*5 Poor reproducibility.
Mior et al. (1996)*11 Poor correlation with Cobb angle.
Mior et al. (1996)*12 Large inter-observer variability.
04098-14.qxd 07/02/2004 17:40 PM Page 143
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Integrated Shape Back shape Carr et al. Carr et al. (1989) Carr et al. Carr et al. 3
Imaging System (1989) (1989) (1989)
(ISIS) (Carr et al.
1989)
Kyphosis Cobb Sagittal Goh et al. Goh et al. (2000); Not tested Numerous 8
angle (Cobb 1948) curvature (2000) Carman et al. (1990)
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Perdriolle Apical Richards (1992)*9; Richards Not tested Lee and Nachemson 8
torsion meter vertebral Barsanti et al. (1992)*10; (1997); Suk et al. (1995);
(Perdriolle and rotation (1990); Omeroglu Weiss (1995) Rajasekaran et al. (1994);
Vidal 1985) et al. (1996) Herzenberg et al. (1990);
Hosman et al. (1996)
CT (Ho et al. Vertebral Ho et al. (1993); Not tested Not tested Numerous 6
1993) rotation Gocen et al. (1998)
MRI (Birchall Vertebral Birchall et al. Not tested Not tested Not reported 1
et al. 1997) rotation (1997)
Richards (1992)*9 70% of measurements over-estimate rotation angle, 47% of measurements 5 wrong.
Richards (1992)*10 66% measurements differ more than 5.
04098-14.qxd 07/02/2004 17:40 PM Page 144
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Radiography Spinal fusion Siambanes and Hamill and Not tested Numerous 6
Mather (1998)*31; Simmons
Larsen et al. (1997)
(1996)*32; Brodsky
et al. (1991)*33;
Lang et al. (1990)*34;
Blumenthal and
Gill (1993)*52;
Kant et al. (1995)*61
Flexion/ Spinal fusion Larsen et al. Not tested Not tested Numerous 4
extension (1996)*26;
radiography Brodsky et al.
(1991)*27
04098-14.qxd 07/02/2004 17:40 PM Page 145
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Lateral bending Spinal fusion Brodsky et al. Hamill and Not tested Numerous 6
radiography (1991)*35 Simmons
(1997)
Tomography Spinal fusion Not tested Not tested Not tested Numerous 4
(Calder et al. 1984)
Computed Spinal fusion Djukic et al. (1990); Not tested Not tested Numerous 6
tomography Brodsky et al.
(1991)*23; Larsen
et al. (1996)*24
Ultrasound Spinal fusion Jacobson et al. Not tested Not tested Not reported 0
(1997)*37
Scintigraphy Spinal fusion (Bohnsack et al. Not tested Not tested Numerous 6
1999); Larsen et al.
(1996)*25
MRI Spinal fusion Lang et al. (1990) Not tested Albert et al. Djukic et al. 5
(1993) (1990)
Roentgen Spinal fusion Not tested Not tested Not tested Lee et al. 3
stereophoto- (1994);
grammetry Johnsson
(Morris et al. 1985) et al. (1992);
Johnsson
et al. (1999)
SPECT Spinal fusion Albert et al. (1998)*36 Not tested Not tested Not reported 0
Siambanes and Mather (1998)*31 Plain films are too unpredictable for assessing spinal fusion.
Larsen et al. (1996)*32 Plain films are too unpredictable for assessing spinal fusion.
Brodsky et al. (1991)*33 Plain films are too unpredictable for assessing spinal fusion.
Lang et al. (1990)*34 Plain films are too unpredictable for assessing spinal fusion.
Blumenthal and Gill (1993)*52 42% false-positive, 29% false-negative results of radiological diagnosis of fusion compared to surgical
findings.
Kant et al. (1995)*61 Radiographs only 68% accurate.
Larsen et al. (1996)*26 Poor comparison with surgical exploration.
Brodsky et al. (1991)* 27 Poor comparison with surgical exploration.
Brodsky et al. (1991)*35 Poor correlation with surgical exploration of fusion mass.
Brodsky et al. (1991)*23 22% inaccuracy compared to surgical exploration.
Larsen et al. (1996)* 24 Poor comparison with surgical exploration.
Jacobson et al. (1997)*37 Sensitive but not specific for pseudo-arthrosis due to overlying hardware.
Larsen et al. (1996)* 25 Poor comparison with surgical exploration.
Albert et al. (1998)*36 Poor sensitivity and specificity for detection of pseudo-arthrosis.
04098-14.qxd 07/02/2004 17:40 PM Page 146
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
X-ray Spinal canal size Not tested Not tested Not tested Numerous 4
X-ray ratio Spinal canal size Blackley et al. Not tested Not tested Numerous 4
(Torg et al. 1986) (1999)*60
CT Spinal canal size Not tested Not tested Not tested Numerous 4
MRI Spinal canal size Not tested Not tested Not tested Herno et al. (1999b) 1
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
MRC grade Motor deficit Inferred Not tested Not tested Numerous 6
(MRC 1976)
Trauma motor Motor deficit Not tested Not tested Not tested Gertzbein (1992); 4
index (Lucas Bondurant
and Ducker et al. (1990);
1979) Cotler et al.
(1990); Wells
and Nicosia
(1995)
Frankel score Neurological Inferred Davis et al. Davis et al. Numerous 10
(Frankel et al. deficit (1993) (1993)*13;
1969) Gertzbein (1992);
Blaustein et al.
(1993)
Sunnybrook Neurological Not tested Davis et al. Davis et al. Pitts et al. 5
Cord Injury deficit (1993) (1993)*14; Segatore (1995)
Scale (Tator 1982) (1991)
ASIA Motor Neurological Not tested Priebe and Not tested Bracken et al. 1
and Sensory deficit Waring (1984)
Scoring System (1991)*15
(Association 1984)
Manabe scale Change in Not tested Not tested Not tested Gertzbein (1992) 1
(Manabe et al. Frankel grade,
1989) and pain
04098-14.qxd 07/02/2004 17:40 PM Page 147
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Davis et al. (1993)*13 Relatively insensitive to important changes in motor, sensory, bladder and walking recovery.
Davis et al. (1993)*14 Insensitive to bladder and walking function.
Priebe and Waring (1991)*15 Poor inter-observer reliability, especially with respect to sensory testing.
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Oswestry Disability Functional outcome Grevitt et al. Fisher and Beurskens Numerous 10
Index (Fairbank measure for patients (1997) Johnson et al. (1996)
et al. 1980) with back pain (1997)
Million Visual Disability and pain Beurskens Beurskens Beurskens Numerous 10
Analogue Scale questionnaire for et al. (1995) et al. (1995) et al. (1995)
(Million et al. patients with back
1982) pain
Roland-Morris Functional outcome Jensen et al. Stratford and Jensen et al. Numerous 10
Disability measure for patients (1992) Binkley (1997) (1992)
Questionnaire with back pain
(Roland and
Morris 1983)
Iowa Low-Back Functional outcome Lehmann Not tested Not tested Not reported 1
Rating Scale measure et al.
(Lehmann et al. (1983)
1983)
04098-14.qxd 07/02/2004 17:40 PM Page 148
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Japanese Orthopedic Outcome of lumbar Inferred Not tested Not tested Numerous 6
Evaluation Criteria spinal surgery
Dallas Pain Impact of spinal Lawlis et al. Lawlis et al. Haas et al. Numerous 8
Questionnaire pain on behaviour (1989) (1989) (1995)
(Lawlis et al. 1989)
Low-Back Outcome Functional outcome Greenough Not tested Taylor et al. Numerous 7
Scale (Greenough measure for patients and Fraser (1999)
and Fraser 1992) with back pain (1992)
Distress and Risk Distress and risk Main et al. Not tested Not tested Tandon et al. 3
Assessment Method assessment (1992) (1999);
(Main et al. 1992) Jamison (1999)
Von Korffs Pain Chronic pain Smith Underwood Not tested Not reported 4
Grade (Von Korff et al. (1997); et al. (1999)
et al. 1992) Underwood
et al. (1999)
Von Korffs Chronic disability Underwood Underwood Not tested Not reported 4
Disability Grade et al. (1999) et al. (1999)
(Von Korff et al.
1992)
Low Back Pain Assessment of low Manniche Manniche Not tested Jensen et al. 5
Rating Scale back pain et al. (1994) et al. (1994) (1996);
(Manniche et al. Manniche
1994) (1995);
Laursen and
Fugl (1995)
Clinical Low Back Functional outcome Ruta et al. Ruta et al. Ruta et al. Moffett et al. 5
Pain (Aberdeen) measure for patients (1994b) (1994b) (1994b) (1999); Leung
Questionnaire with back pain et al. (1999)
(Ruta et al. 1994b)
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
North American Functional outcome Daltroy Daltroy et al. Not tested Not reported 2
Spine Society measure et al. (1996) (1996)
Lumbar Spine
Outcome
Assessment
Instrument
(Daltroy et al.
1996)
Core Outcome Proposed core Not tested Not tested Not tested Not reported 0
Measure (Deyo questions of
et al. 1998) outcome of low
back pain treatment
Back Pain Functional outcome Stratford Stratford Not tested Not reported 2
Functional Scale measure et al. (2000) et al. (2000)
(Stratford et al.
2000)
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Modified Neck pain Not tested Not tested Not tested Blunt et al. 3
Oswestry functional (1997); Zoega
Disability outcome et al. (2000);
Index Palit et al. (1999)
Neck Disability Neck pain Riddle and Vernon and Riddle and Numerous 9
Index (Vernon functional Stratford Mior (1991) Stratford
and Mior 1991) outcome (1998) (1998)
Copenhagen Neck pain Jordan et al. Jordan et al. Jordan et al. Not reported 3
Neck Functional functional (1998) (1998) (1998)
Disability Scale outcome
(Jordan et al.
1998)
Neck Pain and Neck pain and Wheeler et al. Not tested Not tested Not reported 1
Disability Scale disability (1999)
(Wheeler et al.
1999)
04098-14.qxd 07/02/2004 17:40 PM Page 150
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Symptom Severity, Functional Stucki et al. Stucki et al. Stucki et al. Pratt et al. 4
Physical Function, outcome for (1996) (1996) (1996) (2002)
and Satisfaction spinal stenosis
Scale (Stucki et al.
1996)
Shuttle Walking Walking Not tested Pratt et al. Pratt et al. Not reported 4
Test (Singh et al. distance (2002) (2002)
1992) limited by pain
related to spinal
stenosis
Exercise Treadmill Severity of leg Not tested Not tested Not tested Herno et al. 3
with Visual and back pain (1999b); Herno
Analogue Scale after exercise et al. (1999c);
Pain Test (Herno related to spinal Herno et al.
et al. 1994) stenosis (1999a)
Exercise Treadmill Walking distance Not tested Not tested Deen et al. Not reported 1
Test (Deen et al. limited by pain (1998)
1998) related to spinal
stenosis
Exercise Treadmill Exercise-induced Not tested Not tested Tokuhashi Not reported 1
Test Pre and Post leg and back pain et al. (1993)
Body Casting related to lumbar
(Tokuhashi et al. instability
1993)
Macnab Outcome of nerve Not tested Not tested Not tested Numerous 4
Classification root decom-
(Macnab, 1971) pression surgery
Staffer-Coventry Pain and Not tested Not tested Not tested Loupasis 1
Evaluation Criteria functional et al. (1999)
(Staffer and outcome after
Coventry 1972) lumbar fusion
Outcome Tool Functional Samuelsson Not tested Not tested Not reported 1
for Surgery for outcome for et al. (1996)
Neuromuscular neuromuscular
Scoliosis scoliosis
(Samuelsson et al.
1996)
SRS Instrument Functional Haher et al. Haher et al. Not tested Bernstein 4
(Haher et al. 1999) outcome for (1999) (1999) and Hall
adolescent (1998); White
idiopathic et al. (1999)
scoliosis
04098-14.qxd 07/02/2004 17:40 PM Page 152
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Sickness Impact Generic measure McHorney Beaton et al. Beaton et al. Numerous 10
Profile (Bergner of health and Tarlov (1997); Deyo (1997); Deyo
et al. 1981) (1995); Deyo and Diehl and Diehl
and Diehl (1983) (1983) (1983)
Nottingham Health Generic measure McHorney McHorney and Beaton et al. Numerous 10
Profile (Hunt et al. 1985) of health and Tarlov (1995) Tarlov (1995) (1997)
EuroQoL (EuroQol General health Hurst et al. Hurst et al. Hurst et al. Numerous 10
Group 1990) status (1997); (1997); (1997)
Fransen and Fransen and
Edmonds (1999) Edmonds (1999)
Duke Health Profile Generic measure McHorney and McHorney and Beaton et al. Numerous 8
(Parkerson et al. 1990) of health Tarlov (1995) Tarlov (1997)
(1995)*46
SF-36 (Ware and Generic measure McHorney and McHorney and Beaton et al. Numerous 10
Sherbourne 1992) of health Tarlov (1995) Tarlov (1995) (1997)
Quality of Life Profile Quality of life Climent et al. Climent et al. Not tested Climent 3
(Climent et al. 1995) assessment for (1995) (1995) and
adolescents with Sanchez
spinal deformity (1999)
Symptom Checklist-90 Psychological Kinney et al. Not tested Kinney et al. Numerous 6
Revised (SCL-90R) screening in (1991) (1991)*55
(Derogatis et al. 1976) chronic pain
patients
General Health Mental health Goldberg Goldberg and Naughton and Numerous 7
Questionnaire screening and Williams Wiklund
(Goldberg and questionnaire Williams (1988) (1993)*64
Hillier 1979) (1988)
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Walking Index Walking scale Ditunno Ditunno et al. Not tested Not reported 2
(Ditunno et al. 2000) for spinal cord et al. (2000)
injury patients (2000)
Energy expenditure Energy Inferred Sykes et al. Waters et al. Numerous 10
expenditure (1996) (1993)
during walking
EPIC Lift Capacity Lifting capacity Not tested Matheson Not tested Jay et al. 2
Test (Matheson of physically et al. (1995) (2000)
et al. 1995) impaired adults
04098-14.qxd 07/02/2004 17:40 PM Page 154
What does
Instrument it measure? Validated? Reliable? Responsive? Usage Score
Pandyan et al. (1999)*44 Measure of resistance to passive movement, which is a complex measure that can be influenced by many
factors one of which may be spasticity.
Haas et al. (1996)*45 Varying levels of reliability, upper limbs more reliable than lower limbs; Ashworth more reliable than modified
Ashworth.
04098-14.qxd 07/02/2004 17:40 PM Page 155
I need help every day in most aspects of self care. I can stand as long as I want without extra pain.
I can stand as long as I want, but it gives me
I do not get dressed, wash with difficulty and
extra pain.
stay in bed.
Pain prevents me from standing for more than
Section 3: Lifting
1 hour.
I can lift heavy weights without extra pain. Pain prevents me from standing for more than
I can lift heavy weights but it gives extra pain. 1/2 an hour.
Pain prevents me from standing for more than
Pain prevents me from lifting heavy weights
10 minutes.
off the floor but I can manage if they are
conveniently positioned, e.g. on a table. Pain prevents me from standing at all.
04098-14.qxd 07/02/2004 17:40 PM Page 156
THE ROLAND-MORRIS DISABILITY 11. Because of my back, I try not to bend or kneel
QUESTIONNAIRE (RDQ; WITH down.
INSTRUCTIONS) 12. I find it difficult to get out of a chair because
of my back.
When your back hurts, you may find it difficult to
do some things you normally do. 13. My back is painful almost all the time.
This list contains sentences that people have
14. I find it difficult to turn over in bed because of
used to describe themselves when they have back
my back.
pain. When you read them, you may find that some
stand out because that describes you today. As you 15. My appetite is not very good because of my
read the list, think of yourself today. When you back pain.
read a sentence that describes you today, put a tick
16. I have trouble putting on my socks (or
against it. If the sentence does not describe you,
stockings) because of the pain in my back.
then leave the space blank and go on to the next
one. Remember, only tick the sentence if you are 17. I only walk short distances because of my
sure it describes you today. back.
1. I stay at home most of the time because of my 18. I sleep less well on my back.
back.
19. Because of my back pain, I get dressed with
2. I change position frequently to try and get my help from someone else.
back comfortable.
20. I sit down for most of the day because of my
3. I walk more slowly than usual because of my
back.
back.
4. Because of my back, I am not doing any of 21. I avoid heavy jobs around the house because
the jobs that I usually do around the house. of my back.
5. Because of my back, I use a handrail to get 22. Because of my back pain, I am more irritable
upstairs. and bad-tempered with people than usual.
6. Because of my back, I lie down to rest more 23. Because of my back, I go upstairs more slowly
often. than usual.
7. Because of my back, I have to hold on to
24. I stay in bed most of the time because of
something to get out of an easy chair.
my back.
8. Because of my back, I try to get other people
to do things for me.
9. I get dressed more slowly than usual because Scoring the RDQ
of my back.
10. I only stand for short periods of time because The score is the total number of items checked
of my back. that is, from a minimum of 0 to a maximum of 24.
04098-14.qxd 07/02/2004 17:40 PM Page 158
I can look after myself normally, but it causes I have slight headaches which come infre-
extra pain. quently.
It is painful to look after myself and I am slow I have moderate headaches which come infre-
and careful. quently.
I need some help, but manage most of my I have moderate headaches which come fre-
personal care. quently.
I need help every day in most aspects of self care. I have severe headaches which come frequently.
I do not get dressed, I wash with difficulty and I have headaches almost all the time.
stay in bed.
Section 6: Concentration
Section 3: Lifting
I can concentrate fully when I want to, with no
I can lift heavy weights without extra pain. difficulty.
I can lift heavy weights, but it gives extra pain. I can concentrate fully when I want to, with
slight difficulty.
Pain prevents me from lifting heavy weights
off the floor, but I can manage if they are I have a fair degree of difficulty in concentra-
conveniently positioned, for example on a table. tion when I want to.
Pain prevents me from lifting heavy weights I have a lot of difficulty in concentrating when
off the floor, but I can manage light to medium I want to.
weights if they are conveniently positioned.
I have a great deal of difficulty in concentrating
I can lift very light weights. when I want to.
I can only do my usual work, but no more. My sleep is moderately disturbed (23 hours
sleepless).
I can do most of my usual work, but no more.
My sleep is greatly disturbed (35 hours
I cannot do my usual work. sleepless).
I can hardly do any work at all.
My sleep is completely disturbed (57 hours
I cant do any work at all. sleepless).
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performance after spinal cord injury. Clin of measurements of cervical spine range of
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04098-15.qxd 07/02/2004 09:07 AM Page 172
15
Shoulder and elbow
Paul Harvie and Andrew J. Carr
07/02/2004
Source Shoulder- Condition- Common Range (points)
Name reference specific? specific? use? (Worse Best) Comments
09:07 AM
1975) 1975) Based on cohort of 23 patients with
complete ACJ separation
Broadly extended to general
Page 179
shoulder assessment
Rowes Rating Sheet for (Rowe et al. Yes Yes Yes (Dawson et al. 0 100 Based on cohort of 162 Bankart
Bankart Repairs: Rowe 1978) 1999) Excellent 90100 repairs in 161 patients
Score (Cole et al. 2000) Good 7589 More broadly applied to surgery
Fair 5074 for instability
Poor 50
179
follow-up (Dawson et al. 2001)
04098-15.qxd
180
Table 15.1: A summary of outcome scoring methods continued
07/02/2004
Shoulder and Elbow
Source Shoulder- Condition- Common Range (points)
Name reference specific? specific? use? (Worse Best) Comments
09:07 AM
Needs age/gender adjustment for true
inter-score comparisons (Lippitt et al.
1993) (Kuhn and Blasier 1997)
6 30
Page 180
Swanson Shoulder (Swanson Yes Yes No Based on cohort of 35 Swanson Bipolar
Assessment et al. 1989) Excellent 28 Shoulder Arthroplasties for rheumatoid,
Good 2327.9 primary osteo- and post-traumatic
Fair 1822.9 osteoarthritis
Poor 18
07/02/2004
Shoulder Severity (Patte 1987) Yes No No (Beaton and
Index (SSI) Richards 1998)
(Patte 1987) (Beaton
and Richards 1996)
Shoulder Pain And (Pransky et al. Yes No No (Roach et al. 100 0 Uses Visual Analogue Scales
09:07 AM
Disability Index 1997) 1991) (Beaton and Comprised of Pain Scale (5 items) and
(SPADI) Richards 1996) Disability Scale (8 items)
(Williams et al. 1995)
(Heald et al. 1997)
Page 181
Simple Shoulder (Morrey and Yes No No (Lippitt et al. 0 12 Based on cohort of 250 patients with
Test (SST) An 1993) 1993) (Beaton and shoulder pathology
Richards 1998) (Beaton Instability but No fractures included in
and Richards 1996) cohort
(Goldberg et al. 2001a)
181
04098-15.qxd
182
Table 15.1: A summary of outcome scoring methods continued
07/02/2004
Source Shoulder- Condition- Common Range (points)
(Worse Best)
Subjective Shoulder (Kohn and Yes No No 0 100 Initially created in 1988, published in 1996
Rating System (SSRS) Geyer 1997) Based on patients with anterior instability,
09:07 AM
sub-acromial impingement and frozen
shoulder
Not principally for arthroplasty/fracture
assessment
Page 182
American Academy (AAOS 1996) No No No 190 38
of Orthopaedic
Surgeons (Upper
Extremity Scoring
System) (AAOS)
Western Ontario (Kirkley et al. Yes Yes No (Kirkley 2100 0 Applied to both surgically and
Shoulder Instability 1998) et al. 1998) conservatively managed patients with
Index (WOSI) (Kirkley et al. instability
1999) Based on initial cohort of 100 patients
Uses Visual Analogue Scales
21 items covering symptoms/sports,
recreation and work/lifestyle/emotions
Symptoms and (LInsalata et al. Yes No No 17 100 Derived from HSS Shoulder
Function of the 1998) Rating Score HSS
Shoulder Scale
Penn Shoulder (Leggin et al. Yes No No 1 80
Score 1997)
Upper-Extremity (Pransky et al. No No No 8 80 Applied to subjects with chronic,
Functional Scale 1997) non-traumatic work-related,
(UEFS) upper-extremity disorders
Shoulder Disability (van der Yes No No (van der 100 0 16 Pain-Disability-related questions
Questionnaire Heijden et al. Windt et al. 1998) Yes/No answers
2000) (Guyatt et al. All questions relate to preceding
1987) 24 hours only
04098-15.qxd
Oxford Shoulder (Dawson et al. Yes Yes No 60 12 Specifically for assessment of
Instability Score 1999) shoulder instability
07/02/2004
Based on cohort of 92 patients with
shoulder instability treated operatively
or conservatively
Assesses symptoms of Pain and
09:07 AM
Instability as well as activities of daily living
Page 183
1993)
(Schemitsch et al.
1996)
Hospital for Special (Inglis and Yes No No (Turchin et al. 0 100 Initially used for assessment of elbow
Surgery Elbow Pellicci 1980) 1998) arthroplasty (Pynsent et al. 1993)
Assessment (Figgie et al. 1989) Also applied to elbow trauma
183
04098-15.qxd
184
07/02/2004
Table 15.1: A summary of outcome scoring methods continued
09:07 AM
Mayo Elbow (Morrey and Yes No Yes (Lee and 0 100 Also applied to trauma (Rodgers et al.
Performance An 1993) Morrey 1997) 1996) (Cobb and Morrey 1997);
Score (MEPS) (Kudo 1998) (Schneeberger et al. 1997)
Page 184
(Connor and
Morrey 1998)
(Gill and Morrey,
1998) (Mansat
and Morrey 1998)
(Gill et al. 2000)
07/02/2004
The Shoulder: Clinician-based shoulder scores
Arner Assessment (Arner et al. Yes Yes No Not numerically Assessment of surgical management
1957) scored of ACJ dislocation
Extended by Walsh in 1985 (Walsh
et al. 1985) and further by MacDonald
09:07 AM
in 1988 (MacDonald et al. 1988)
Neer Rating (Neer 1970) Yes Yes Yes (Svend-Hansen, 0 100 Based on cohort of 117 patients
1974) (Hagg and Excellent 89 with 3- and 4-part proximal
Lundberg 1994) Satisfactory 8089 humeral fractures
Page 185
Kocialkowski and Unsatisfactory Result in any patient with significant
Wallace 1990) 7079 pain is failure
(Jakob et al. 1990) Failure 70
Wolfgang Rating (Wolfgang Yes Yes No 0 17 Based on cohort of 74 open rotator
1974) Excellent 1417 cuff repairs in 73 patients
185
04098-15.qxd
186
Table 15.1: A summary of outcome scoring methods continued
07/02/2004
Shoulder and Elbow
Source Shoulder- Condition- Common Range (points)
Name reference specific? specific? use? (Worse Best) Comments
09:07 AM
Post and Singh (Post and Yes Yes No Post-operative Based on cohort of 59 open rotator
Assessment Singh 1983) pain relief cuff repairs in 55 patients
0 75 Assesses Pain (major component)
Excellent 7075 and Function (minor component)
Page 186
Good 6069 Different pre- and post-operative
Fair 5059 assessment criteria
Poor 50 Separate Pain and Function
Constant (Constant Yes No Yes (Constant and 0 100 Adopted by European Shoulder and
(Constant-Murley) and Murley Murley 1987) Elbow Society
Score 1987) (Conboy et al. 1997) Not applicable to instability
(Dawson et al. 2001) (Conboy et al. 1997)
(Hessman et al. 1998) May be imprecise for long-term
(Bosch et al. 1998) follow-up (Dawson et al. 2001)
(Hessman et al. 1999) Needs age/gender adjustment for true
inter-score comparison (Lippitt
et al. 1993) (Kuhn and Blasier 1997)
25% of score allocated to Power
Hospital for (Altchek et al. Yes No (Bosch No (Bosch et al. 0 100 Fracture patients NOT included in initial
Special Surgery 1990) et al. 1998) 1998) Excellent 90100 cohort
Shoulder Rating Good 7089
Score (HSS) Fair 5069
Poor 50
04098-15.qxd
The Shoulder: Patient-based shoulder scores
5 20
07/02/2004
Walsh (Walsh et al. Yes Yes No (Kuhn and Extension of Arner assessment for ACJ
Questionnaire 1985) Blasier 1997) dislocation
Shoulder Pain (Roach et al. Yes No Yes (Roach et al. 0 100 Broadly applied to shoulder trauma
and Disability 1991) 1991) (Roddey BUT patients with fractures
Index (SPADI) et al. 2000) EXCLUDED from original cohort
09:07 AM
(Beaton and (Roach et al. 1991)
Richards 1996)
(Williams et al.
1995) (Heald
Page 187
et al. 1997)
Simple Shoulder (Lippitt et al. Yes No No (Roach et al. 0 12 Broadly applied to trauma but
Test (SST) 1993) 1991) (Beaton and No patients with fractures included
Richards 1996) in original cohort (Morrey and An 1993)
(Williams et al. 1995)
187
04098-15.qxd
188
Table 15.1: A summary of outcome scoring methods continued
07/02/2004
Shoulder and Elbow
Source Shoulder- Condition- Common Range (points)
Name reference specific? specific? use? (Worse Best) Comments
40 0
09:07 AM
Vienna Shoulder (Gaebler et al. Yes No No Based on cohort of 157 patients with
Score (VSS) 1997) clavicular fractures
Applied to all shoulder girdle trauma
Shoulder Disability (van der Yes No No 100 0 16 Pain-Disability-related questions
Page 188
Questionnaire Heijden et al. (van der Windt Yes/No answers
2000) et al. 1998) All questions relate to preceding
(Guyatt et al. 1987) 24 hours only
Oxford Shoulder (Dawson et al. Yes Yes No 60 12 Specifically for assessment of shoulder
Instability Score 1999) instability
Based on cohort of 92 patients with instability
treated operatively or conservatively
Assesses symptoms of Pain and Instability
as well as Activities of Daily Living
The Elbow: Clinician-based scores
Bruce Assessment (Bruce et al. Yes Yes No 0 100 Based on cohort of 35 patients with
1974) Excellent 96100 Monteggia fractures
Good 9195
Fair 8190
Poor 81
Hospital for Special (Inglis and Yes No No 0 100 Initially developed for elbow arthroplasty
Surgery Elbow Pellicci 1980) assessment (Pynsent et al. 1993)
Assessment (HSS)
Holdsworth and (Holdsworth Yes Yes No 1 16 Based on cohort of 52 patients undergoing
Mossad and Mossad ) Excellent 1416 tension band wiring of olecranon fracture
1984 Good 1113
Poor 11
Broberg and (Broberg and Yes Yes Yes (Wallenbock 0 100 Based on cohort of 21 patients undergoing
Morrey Scale Morrey 1986) and Potsch 1997) Excellent 95100 delayed radial head excision
04098-15.qxd
(Functional Rating (Ikeda et al. 2001) Good 8094 after fracture
Index) (Ring et al. 1998) Fair 6079
07/02/2004
(Ring et al. 1997) Poor 60
(Broberg and
Morrey 1987)
Mayo Elbow (Morrey and Yes No Yes (Gill et al. 0 100 Most frequently applied elbow score
09:07 AM
Performance An 1993) 2000) (Rodgers
Score (MEPS) et al. 1996)
(Cobb and
Morrey 1997)
Page 189
(Schneeberger
et al. 1997)
Leipzig Elbow (Korner et al. Yes Yes No (MacDermid 0 100 Based on cohort of 41 patients with
Score 1998) 2001) Excellent 90100 elbow fracture-dislocations
Good 8089 Includes component for radiographic
189
04098-15.qxd 07/02/2004 09:07 AM Page 190
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04098-16.qxd 06/02/2004 14:36 PM Page 196
16
The wrist
Joseph J. Dias
Strength
Scores
Grip strength measurement is simple and quick and
can be easily performed in a busy clinic. Abolishing pain and improving function are the
Almost all conditions affecting the wrist have a primary aims of most interventions for the wrist. It
direct impact on grip strength, and this establishes is therefore surprising that very few assessments of
whether any intervention has been beneficial. Assess- outcome for wrist disorders include an assessment
ment of strength is indirect and depends on many of function before and after intervention.
factors such as motivation, intact neuromuscular
structure and anatomical and functional integrity WRIST SCORES
of the forearm, wrist and hand. There are a number of wrist scores (Table 16.1),
The most commonly recommended and reliable which are usually generated by a combination
device to assess grip strength is the Jamar hydraulic of symptoms, impairments, disabilities and compli-
hand dynamometer with adjustable handle settings cations, and some even include radiographic eval-
(Mathiowetz et al. 1984). The device should be regu- uation. The content and quality of 32 wrist
larly calibrated and, if used to measure change with outcome measures were systematically reviewed by
time, the same instrument should be used at each Bialocerkowski et al. (2000). These authors found
assessment. The handles of such a device are set at that 82 per cent of the measures contained meas-
the second position unless a five-position strength urement of range and/or strength, and disability was
is being assessed. The patient is seated with the assessed by 31 per cent. However, these outcome
shoulder adducted and neutrally rotated, elbow measures were considered of generally poor quality.
04098-16.qxd 06/02/2004 14:36 PM Page 200
Green and OBrien wrist score reporting outcome of wrist instability, but has not
Most can be traced back to the score proposed by been validated nor its reliability and responsiveness
Green and OBrien (1978) (Table 16.2). This is a determined.
demerit score looking at a symptom (pain), disability
(work), impairment in the flexion extension arc and Gartland and Werley (Modified) score
strength and one investigation: an X-radiograph. The commonest score used to report on outcome of
The score is obviously meant to be generated by the a fracture of the distal radius is the Gartland and
doctor after a detailed interview, examination and Werley score and its modifications (Stewart et al.
after review of an X-radiograph. Modifications of 1985) (Table 16.4). This score is a mixture of impair-
this score have been used to report outcomes in ments, symptoms and disability, with demerit points
various wrist disorders. However, the score has not for each and a categorization of the outcome into
been validated, nor its reliability and responsiveness excellent, good, fair and poor.
checked.
Subjective evaluation
Pain None (1) Occasional (2) Often (3)
Limitation of movement None (4) Slight (5) Present (6)
Disability None (7) None if careful (8) Present (9)
Restriction of activities None (10) Slight (11) Marked (12)
Demerit points
1, 4, 7, 10 Excellent 0
2, 5, 7, 10 Good 2
2, 5, 8, 11 Fair 4
3, 6, 9, 12 Poor 6
Other multiples are averaged out, with a tendency to mark towards the poor side
e.g. 1, 4, 9, 11 Fair
2, 4, 9, 10 Fair
Objective evaluation
Wrist extension if less than 45 5
Wrist flexion if less than 30 1
Wrist ulnar inclination if less than 25 3
Wrist radial inclination if less than 15 1
Supination if less than 50 2
Pronation if less than 50 2
Circumduction if unable to do well 1
Finger flexion if all do not flex to distal palmar crease 1
if one or two do not flex to distal palmar crease 1
Grip strength if decreased compared with normal side 1
Complications
Median/ulnar/radial sensory nerve compression Mild 1
Moderate 2
Severe 3
dominance of the hand. However, it may not allow such tests for the hand (Macey and Kelly 1993).
comparison between patients. These activities should ideally be independent of
In order to assess disability, a standard assessment dominance or sex, and should also include domestic,
of daily activities can be used, and there are many occupational and leisure tasks. The availability of
04098-16.qxd 06/02/2004 14:36 PM Page 203
Name: Date:
PATIENT-RATED WRIST EVALUATION
The questions below will help us understand how much difficulty you have had with your wrist in the past week. You will be
describing your average wrist symptoms over the past week on a scale of 010. Please provide an answer for ALL questions.
If you did not perform an activity, please ESTIMATE the pain or difficulty you would expect. If you have never performed
the activity, you may leave it blank.
1. PAIN
Rate the average amount of pain in your wrist over the past week by circling the number that best describes your pain on a
scale from 010. A zero (0) means that you did not have any pain and a ten (10) means that you had the worst pain you
have ever experienced or that you could not do the activity because of pain.
Sample scale 0 1 2 3 4 5 6 7 8 9 10
No Pain Worst Ever
2. FUNCTION
A. SPECIFIC ACTIVITIES
Rate the amount of difficulty you experienced performing each of the items listed below, over the past week, by circling the
number that describes your difficulty on a scale of 010. A zero (0) means you did not experience any difficulty and a ten
(10) means it was so difficult you were unable to do it at all.
Sample scale 0 1 2 3 4 5 6 7 8 9 10
No Difficulty Unable To Do
B. USUAL ACTIVITIES
Rate the amount of difficulty you experienced performing your usual activities in each of the areas listed below, over the past
week , by circling the number that best describes your difficulty on a scale of 010. By usual activities, we mean the
activities you performed before you started having a problem with your wrist. A zero (0) means that you did not experience
any difficulty and a ten (10) means it was so difficult you were unable to do any of your usual activities.
Comments
Comment/Interpretations:
Pain Subscale /50
Function Subscales (total divided by 2) /50
Total PRWE Score (Sum) /100
Where items are left blank, the average score of that subscale can be substituted
the Baltimore Therapeutic Equipment (BTE) work Comparison of radiographs obtained before inter-
simulator has helped analyse motor performance vention and at a reasonable time after the inter-
and conduct motion time measurements in order to vention for wrist conditions provides a further
quantify the physical attributes of disability. It allows objective assessment of outcome for several con-
the evaluation of manual dexterity and helps to ditions of the wrist which involve the bones and
predict skills (Curtis and Engalitcheff 1981). joints.
Patient-completed questionnaires to assess disabil- Radiographs provide us with information regard-
ity have been developed for the upper limb. The ing the integrity of the individual bones making up
Disabilities of the Arm, Shoulder and Hand (DASH) the wrist, the alignment of these bones, and the
(Hudak et al. 1996), the Patient Evaluation Measure state of the joints. It is usual to obtain at least two
(PEM) (Dias et al. 2001) and the Michigan Hand views of the wrist the postero-anterior and the
Questionnaire (Chung et al. 1998) are the three cur- lateral. It is essential to obtain standard views if
rently in use. Each is valid and reliable, and respon- radiographs are to be used for measurement.
siveness has been demonstrated for the PEM. These Any radiograph of the wrist must include at least
systems are discussed in detail in Chapter 17. the distal third of the radius and ulna and the whole
of the middle metacarpal in the image. The middle
metacarpal must always (if possible) lie in line with
RADIOGRAPHIC ASSESSMENT the radius. The distance of the radiographic plate
must be standard at 1 m and the thumb placed in
Radiographic views maximum abduction.
The posterior-anterior view must be taken with
Radiographs provide a picture of the anatomical the shoulder abducted at 90 and the elbow flexed to
abnormality within the wrist (Wilson et al. 1990). 90. In this position, the forearm is in the anatomical
04098-16.qxd 06/02/2004 14:36 PM Page 205
References 207
Dias, J. J., Bhowal, B., Wildin, C. J., and Thompson, J. R. lateral wrist radiographs. Hand Surg 16A,
(2001): Assessing outcome of hand disorders. Is 88893.
the Patient Evaluation Measure (P.E.M.) reliable, Larsen, C. F., Stigsby, B., Lindquist, S., Bellstrom, T.,
valid, responsive and without bias? Bone Joint Mathiesen, F. K., and Ipsen, T. (1991b): Observer
Surg 83, 23540. variability in measurements of the carpal bones
Epner, R. A., Bowers, W. H., and Guilford, W. B. angles on lateral wrist radiographs. Hand Surg
(1982): Ulnar variance The effect of wrist 16A, 8938.
positioning and roentgen filming technique. LaStayo, P. C., and Wheeler, D. L. (1994): Reliability of
Hand Surg 7A, 298305. passive wrist flexion and extension goniometric
Feinstein, W. K., Lichtman, D. M., Noble, P. C., measurements: a multicenter study. Phys Ther
Alexander, J. W., and Hipp, J. A. (1999): 74, 16274.
Quantitative assessment of the midcarpal shift MacDermid, J. C., Turgeon, T., Richards, R. S.,
test. J Hand Surg 24, 97783. Beadle, M., and Roth, J. H. (1999): Patient
Geertzen, J. H., Dijkstra, P. U., Stewart, R. E., rating of wrist pain and disability: a reliable and
Groothoff, J. W., Ten Duis, H. J., and valid measurement tool. Orthop Trauma 12,
Eisma, W. H. (1998): Variation of measurements 57786.
of range of motion: a study in reflex sympathetic MacDermid, J. C., Richards, R. S., Donner, A., Bellamy,
dystrophy patients. Clin Rehab 12, 25464. N., and Roth, J. H. (2000): Responsiveness of
Gilula, L. A. (1979): Carpal injuries: analytic the short form-36, disability of the arm, shoulder
approach and case exercises. Am J Roentgenol and hand questionnaire, patient-rated wrist
133, 503. evaluation, and physical impairment
Green, D. P., and OBrien, T. (1978): Open reduction of measurements in evaluating recovery after a
carpal dislocations indications and operative distal radius fracture. J Hand Surg 25, 33040.
techniques. J Hand Surg 3A, 25065. Macey, A., and Kelly, C. (1993): The hand. In: Pynsent,
Horger, M. M. (1990): The reliability of goniometric P., Fairbank, J., and Carr, A. (eds), Outcome
measurements of active and passive wrist Measures in Orthopaedics. Butterworth
motions. Am J Occup Ther 44, 3428. Heinemann, Oxford, pp. 17493.
Hudak, P. L., Amadio, P. C., and Bombadier, C. (1996): Mathiowetz, V., Weber, K., Volland, G., and
Development of an upper extremity outcome Kasnman, N. (1984): Reliability and validity of
measure: The DASH (disabilities of the arm, grip and pinch strength evaluations. Hand Surg
shoulder and hand). The Upper Extremity 9A, 2226.
Collaborative Group (UECG). Am J Ind Med 29, Mathiowetz, V., Kasnman, N., Volland, G., Weber, K.,
6028. Dowe, M., and Rogers, S. (1985): Grip and
International Federation of Societies for Surgery of the pinch strength: normative data for adults. Arch
Hand (2001): Terminology for Hand Surgery. Phys Med Rehabil 66, 6974.
Harcourt Health Sciences, London. Mathiowetz, V., Wiemer, D. M., and Federman, S. M.
Kaye, J. J. (1991): Radiographic methods of assessment (1986): Grip and pinch strengths: norms
(scoring) of rheumatic disease. Rheum Dis Clin for 6 to 19 year olds. Am J Occup Ther 40,
North Am 17, 45770. 70511.
Kaye, J. J., Fuchs, H. A., Moseley, J. W., Nance, E. P., Moore, M. L. (1949): The measurement of Joint
Callahan, L. F., and Pincus, T. (1990): Problems Motion. Part II. The technic of goniometry. Phys
with the Steinbrocker staging system for Ther Rev 29, 256.
radiographic assessment of the rheumatoid hand ODriscoll, S. W., Horii, E., Ness, R., Calahan, T. D.,
and wrist. Invest Radiol 25, 53644. Richards, R. R., and Au, K. N. (1992): The
Larsen, C. F., Mathiesen, F. K., and Lindquist, S. relationship between wrist position, grasp size,
(1991a): Measurements of carpal bone angles on and grip strength. Hand Surg 17, 16977.
04098-16.qxd 06/02/2004 14:36 PM Page 208
17
The hand
T. R. C . Davis
Grade Recovery of sensibility (MRC) Seddons scale Static 2-PD (mm) Moving 2-PD (mm)
Outcome questionnaires
Carpal Tunnel Questionnaire Carpal tunnel syndrome 1 1 1 4 7
(Levine et al. 1993)
DASH (Hudak et al. 1996) Arm function 2 2 2 4 10
Hand Clinic Questionnaire General hand outcome 2 2 0 4
(HCQ) (Sharma and Dias 2000)
Hand Outcome Severity Score General hand outcome 2 Moderate 1 3
(HOSS) (Sharma and Dias 2000) only
Michigan Hand Questionnaire General hand outcome 1 1 1 3 6
(Chung et al. 1998)
Patient Evaluation Measure (PEM) General hand outcome 2 2 2 3 9
(Sharma and Dias 2000)
Sensation
Mobile 2-point discrimination Sensory function 02 1 4 57
(Dellon 1978)
Static 2-point discrimination Sensory function 02 1 4 57
(Moberg 1958)
Sensory Threshold Pressure Sensory function 2 4 6
(Semmes-Weinstein Filaments)
(Marsh 1990)
Sensory localization (Jerosch- Sensory function 2 1 3
Herold 1993; Marsh 1990)
Finger movement
Finger joint goniometry Finger joint mobility 2 2 2 4 10
(Groth et al. 2001; Hamilton
and Lachenbruch 1969)
Strickland (Strickland 1985; Finger flexor tendon 4 4
Strickland and Glogovac 1980) surgery outcome
04098-17.qxd 06/02/2004 14:36 PM Page 221
References 221
Table 17.6: A summary of outcome measures continued
Muscle strength
5-position grip strength test Feigned hand weakness 2 2
(Tredgett et al. 1999)
Rapid exchange grip strength Feigned hand weakness 2 1 3 6
test (Joughin et al. 1993;
Westbrook et al. 2002)
Intrinsic muscle dynamometer Intrinsic muscle strength 2 1 1 2 6
(Schreuders et al. 2000)
Other
Percival Score (Percival Outcome of thumb 4 4
et al. 1991) pollicization
References 223
Rege, A., and Sher, J. (2001): Can outcome of carpal normal subjects: importance of the left brain.
tunnel release be predicted? J Hand Surg 26B, Int J Neurosci 72, 7987.
14850. Tredgett, M., and Davis, T. (2000): Rapid repeat testing
Rose, V., Nduka, C., Pereira, J., Pickford, M., and of grip strength for detection of faked hand
Belcher, H. (2002): Visual estimation of finger weakness. J Hand Surg 25B, 3725.
angles: do we need goniometers? J Hand Surg Tredgett, M., Pimble, L., and Davis, T. (1999): The
27, 3824. detection of feigned hand weakness using the five
Schreuders, T., Roebroeck, M., van der Kar, T., position grip strength test. J Hand Surg 24B,
Soeters, J., Hovius, S., and Stam, H. (2000): 4268.
Strength of the intrinsic muscles of the hand Tsuge, K., Ikuta, Y., and Matsuishi, Y. (1977): Repair of
measured with a hand-held dynamometer: flexor tendons by intratendinous tendon suture.
reliability in patients with ulnar and median J Hand Surg 2, 43640.
nerve paralysis. J Hand Surg 25B, 5605. Tubiana, R., Thomine, J.-E., and Mackin, E. (1996):
Seddon, H. (1972): Surgical Disorders of the Peripheral Examination of the Hand and Wrist. Martin
Nerves. Churchill Livingstone, Edinburgh. Dunitz, London.
Sharma, R., and Dias, J. (2000): Validity and reliability Westbrook, A. P., Tredgett, M. W., Davis, T. R., and
of three generic outcome measures for hand Oni, J. A. (2002): The rapid exchange grip
disorders. J Hand Surg 25B, 593600. strength test and the detection of submaximal
Steenhuis, R. E., Bryden, M. P., Schwartz, M., and grip effort. J Hand Surg 27, 32933.
Lawson, S. (1990): Reliability of hand preference White, W. (1956): Secondary restoration of finger
items and factors. J Clin Exp Neuropsychol function by digital tendon grafts. Am J Surg
12, 92130. 91, 6628.
Strickland, J. (1985): Results of tendon surgery in zone Wiles, C. M., and Edwards, R. H. (1982): The effect of
2. Hand Clinics 1, 16779. temperature, ischaemia and contractile activity
Strickland, J., and Glogovac, S. (1980): Digital function on the relaxation rate of human muscle. Clin
following flexor tendon repair in zone 2: a com- Physiol 2, 48597.
parison of immobilization and controlled passive Young, V., Pin, P., Kraemer, A., Gould, R.,
motion techniques. J Hand Surg 5, 53743. Mnemergut, L., and Pellowski, M. (1989):
Tan, U., Komsuoglu, S., and Akgun, A. (1993): Inverse Fluctuation in grip and pinch strength among
relationship between the size of pattern reversal normal subjects. J Hand Surg 14A, 1259.
visual evoked potentials from the left brain and Zachary, R., and Holmes, W. (1946): Primary suture of
the degree of left-hand preference in left-handed nerves. Surg Gynecol Obstet 82, 63251.
04098-17.qxd 06/02/2004 14:36 PM Page 224
APPENDIX
Outcome questionnaires
How severe is the hand or wrist pain that 3 Three to five times a day
you have at night? 4 More than five times a day
1 I do not have hand or wrist pain at night 5 The pain is constant
2 Mild pain
3 Moderate pain
How long, on average, does an episode of
4 Severe pain
pain last during the daytime?
5 Very severe pain
1 I never get pain during the day
2 Less than 10 minutes
How often did hand or wrist pain wake you up 3 10 to 60 minutes
during a typical night in the past two weeks? 4 Greater than 60 minutes
1 Never 5 The pain is constant throughout the day
2 Once
3 Two or three times
4 Four or five times Do you have numbness (loss of sensation)
5 More than five times in your hand?
1 No
Do you typically have pain in your hand or 2 I have mild numbness
wrist during the daytime? 3 I have moderate numbness
1 I never have pain during the day 4 I have severe numbness
2 I have mild pain during the day 5 I have very severe numbness
3 I have moderate pain during the day
4 I have severe pain during the day Do you have weakness in your hand
5 I have very severe pain during the day or wrist?
1 No weakness
How often do you have hand or wrist pain 2 Mild weakness
during the daytime? 3 Moderate weakness
1 Never 4 Severe weakness
2 Once or twice a day 5 Very severe weakness
* Reprinted from The Journal of Bone and Joint Surgery, 75A, Levine et al., A self-administered questionnaire for the assessment of
severity of symptoms and functional status in carpal tunnel syndrome, 158592, 1993.
04098-17.qxd 06/02/2004 14:36 PM Page 225
Appendix 225
Cannot do due
Mild Moderate Severe to hand or
Activity No difficulty difficulty difficulty difficulty wrist symptoms
Writing 1 2 3 4 5
Buttoning of clothes 1 2 3 4 5
Holding a book while reading 1 2 3 4 5
Gripping of a telephone handle 1 2 3 4 5
Opening of jars 1 2 3 4 5
Household chores 1 2 3 4 5
Carrying of grocery bags 1 2 3 4 5
Bathing and dressing 1 2 3 4 5
The overall score for functional status was calculated as the mean of the eight items. Items that were left unanswered or that were not
applicable were not included in the calculation of the overall score.
04098-17.qxd 06/02/2004 14:36 PM Page 226
INSTRUCTIONS: This questionnaire asks about If you did not have the opportunity to perform
your symptoms as well as your ability to perform an activity in the past week, please make your
certain activities. best guess as to which response would have been
most accurate.
Please answer every question, based on your It doesnt matter which hand or arm you use to
condition in the last week, by circling the perform the activity; please answer based on your
appropriate number. ability, regardless of how you perform the task.
Please rate your ability to do the following activities in the last week by
circling the number in the box below the appropriate response
* This DASH Outcome Measure is not to be reproduced or copied in any way. For more information and to download the DASH
Outcome Measure, visit www.dash.iwh.on.ca
04098-17.qxd 06/02/2004 14:36 PM Page 227
Appendix 227
Not Quite
at all Slightly Moderately a bit Extremely
Please rate the severity of the following symptoms in the last week (circle number)
So much
No Mild Moderate Severe difficulty that
difficulty difficulty difficulty difficulty I cant sleep
Neither
Strongly agree nor Strongly
disagree Disagree disagree Agree agree
Appendix 229
I. The following questions refer to the function of your hand(s)/wrist(s) during the past
week. (Please circle one answer for each question.)
A. The following questions refer to your right hand/wrist.
II. The following questions refer to the ability of your hand(s) to do certain tasks during
the past week. (Please circle one answer for each question.)
A. How difficult was it for you to perform the following activities using your right hand?
*Reprinted from the Journal of Hand Surgery 23A, Chung et al., Reliability and validity testing of the Michigan hand outcomes
questionnaire, 57587, 1998 American Society for Surgery of the Hand.
04098-17.qxd 06/02/2004 14:36 PM Page 230
B. How difficult was it for you to perform the following activities using your left hand?
C. How difficult was it for you to perform the following activities using both of your hands?
1 Open a jar 1 2 3 4 5
2 Button a shirt/blouse 1 2 3 4 5
3 Eat with a knife/fork 1 2 3 4 5
4 Carry a grocery bag 1 2 3 4 5
5 Wash dishes 1 2 3 4 5
6 Wash your hair 1 2 3 4 5
7 Tie shoelaces/knots 1 2 3 4 5
III. The following questions refer to how you did in your normal work (including both
housework and school work) during the past 4 weeks. (Please circle one answer for
each question.)
Always Often Sometimes Rarely Never
Appendix 231
IV. The following questions refer to how much pain you had in your hand(s)/wrist(s)
during the past week. (Please circle one answer for each question.)
1 How often did you have pain in your hand(s)/wrist(s)?
1 Always
2 Often
3 Sometimes
4 Rarely
5 Never
If you answered never to question IV-1 above, please skip the following questions and go
to the next page.
2 Please describe the pain you have in your hand(s)/wrist(s).
1 Very mild
2 Mild
3 Moderate
4 Severe
5 Very severe
V.
A. The following questions refer to the appearance (look) of your right hand during the past week. (Please circle one answer for each
question.)
Neither
Strongly agree nor Strongly
agree Agree disagree Disagree disagree
B. The following questions refer to the appearance (look) of your left hand during the past week. (Please circle one answer for each
question.)
Neither
Strongly agree nor Strongly
agree Agree disagree Disagree disagree
VI.
A. The following questions refer to your satisfaction with your right hand/wrist during the past week. (Please circle one answer for
each question.)
Neither
Strongly agree nor Strongly
agree Agree disagree Disagree disagree
Appendix 233
Neither
Strongly agree nor Strongly
agree Agree disagree Disagree disagree
B. The following questions refer to your satisfaction with your left hand/wrist during the past week. (Please circle one answer for each
question.)
Neither
Strongly agree nor Strongly
agree Agree disagree Disagree disagree
Please provide the following information about yourself. (Please circle one answer for
each question.)
1 Are you right or left handed?
a Right handed
b Left handed
c Both
2 Which hand gives you the most problem?
a Right hand
b Left hand
c Both
3 Have you changed the type of job you did before you had problems with your hand(s)?
a Yes
b No
Please describe the type of job you did before you had problems with your hand(s).
4 What is your gender?
a Male
b Female
04098-17.qxd 06/02/2004 14:36 PM Page 234
7 What is your family income, including wages, disability payment, retirement income, and
welfare?
a $10,000
b $10,000$19,000
c $20,000$29,999
d $30,000$39,999
e $40,000$49,999
f $50,000$59,999
g $60,000$69,999
h $70,000
Appendix 235
Instructions These questions are about how you have been treated at the hospital, and how your hand is now.
There are no right or wrong answers. For each question, give your answer by placing a circle around the number
which shows best how things are for you.
For example:
The PAIN in my hand is:
non-existent 1 2 3 4 5 6 7 unbearable
this circle indicates that the pain is
quite bad, but is not unbearable.
*Reprinted from The Journal of Hand Surgery, 20B, Macey, A. C., and Burke, F. D., Outcomes of hand surgery, 84155, 1995, with
permission from the British Society for Surgery of the Hand.
04098-18.qxd 06/02/2004 14:36 PM Page 237
18
Pelvic and acetabular fractures
Philip J. Chapman-Sheath and Keith M. Willett
measure that can be utilized for different fracture although they all vary in the groups studied and the
series and between different treatments. The weak- associated injuries. Although they cannot be utilized
ness is in determining the contribution of the pelvic as a comparative group for all future studies, they do
injury to that overall mortality. Ideally, the total spec- provide a guide to previously determined mortality
trum of injuries and the proportion of each injury rates in specific fracture groups.
group should be fully defined in each study and not
simply allocated a number from one of the many
injury scoring systems, such as the injury severity Morbidity
score (ISS). Studies have confirmed that by using such
a system, patients who score the same overall trauma Numerous components of morbidity have been stud-
score will have quite different injuries to different ied within pelvic fracture series. They include injuries
body systems which may not all contribute to the to other body systems as well as the musculoskeletal
overall mortality. All patients should be followed up system. Many studies have simply identified one
over a reasonable time course, and consensus appears outcome of morbidity to record and have not used
to favour greater than one year. The use of mortality any standardized method of recording or analysing
as an outcome measure is highly reliable if the above the data. Accordingly, there are no validated and
factors are considered and in addition, if there is a standardized morbidity outcome measures currently
complete data set. The use of mortality as an out- available. Studies which have attempted to use mor-
come measure in pelvic fractures associated with bidity as an outcome measure, together with details
severe trauma therefore, would appear useful. of the composition of the group sampled are listed in
The studies outlined in Table 18.1 have all utilized Table 18.2. Specific analysis and detailed discussion
mortality as the outcome measure in pelvic fractures, is lacking in most of these studies, however, and
04098-18.qxd 06/02/2004 14:36 PM Page 239
often the mere presence of an injury is stated without utilizing a validated pain score, which are subjective
qualification as to the grade or severity of injury. patient-based outcome measures. These have been
Note should be made of the usefulness of each of shown to be both reproducible and reliable in pre-
the factors listed in the table as an outcome measure. vious studies. They can be utilized in addition to
The presence or absence of vascular injury can be standard validated psychometric testing, such as the
used as a valid outcome measure of pelvic fracture, validated SF-36 questionnaire. They are all, however,
but no study has quantified the degree or extent of prone to high inter-study and inter-patient variabil-
injury. The presence of sphincteric injury includes the ity, and also cannot alone be used for the assessment
urogenital and gastrointestinal tract, but few studies of final outcome, as the function score may not cor-
include quantifiable data or manometric assessment relate with pain score. Many studies have merely
values. Neurological injury is described in these stud- quoted the incidence of pain in the study population
ies in terms of limp, pain and loss of function again of patients with pelvic fractures, and those listed in
without standardized quantifiable and therefore Table 18.3 provide some idea as to both the number
reproducible assessment. Indeed, as with an assess- of patients and the type of fractures studied.
ment of sexual function, the previous two outcome
measures of sphincteric injury and neurological func-
tion are highly subjective assessments which are Gait
enquiry-dependent and therefore maybe subject to
substantial recording bias. The individual weighting Several studies reported in the literature have utilized
of each complication on the overall subjective mor- a measure of gait as the outcome measure for pelvic
bidity has not been determined in studies to date. The fractures. None of the specific scores or measurement
following lists, however, provide useful guidance to systems is routinely or widely utilized however, and
study designers for detection of contributing factors most are used by one or few institutions. The studies
and their incidence. detailed in Table 18.4 are therefore isolated studies
with no direct means of comparison. The majority
of the studies suffer from the fact that the analysis
PAIN of gait is subjective and difficult to quantify. These
methods of assessment lack the reproducibility and
The incidence of pain as an outcome measure for sensitivity of modern computerized gait analysis tech-
pelvic fractures is less useful than those studies niques, but are of course much cheaper and available
04098-18.qxd 06/02/2004 14:36 PM Page 241
Pain 241
Table 18.3: Pain in pelvic fracture
NA not available.
04098-18.qxd 06/02/2004 14:36 PM Page 242
Scoring systems
Radiology
The inherent problem with the use of most scoring
systems for the assessment of outcomes is that they Both radiography and computed tomography (CT)
are composite scores. They comprise an amalg- have been utilized as an outcome measure of pelvic
amation of scores based on clinical and radiological fractures. Both have been shown to be reliable at
criteria. In addition, the clinical data comprise both showing displacement of fracture fragments, but
subjective patient-based data (known to be reli- only CT has proved to be reliable and sensitive
able) and subjective clinician-based data. Composite enough to identify fracture non-union and to meas-
scores have the disadvantage already mentioned for ure malunions.
the ISS in that two patients may have identical No standardized outcome measure has been used,
scores overall, but have different scores for each and each centre still uses its own system of analysis
criteria. There is little reason to assume that scores which makes direct and valid comparison between the
allocated within criteria are proportional, or that groups difficult. Studies utilizing radiographic out-
they may be summed in any meaningful way with a come assessment of pelvic fractures, and the groups
score given for another criteria. None of the scoring which were measured, are listed in Table 18.6.
Pain 243
Table 18.5: Scoring systems in pelvic fracture continued
Majeed outcome 78.6 (SD 0 (poor)100 (good) 37 Van den Bosch Unstable
score unknown) (1999) fractures
Non-union Incidence (%) No. of patients Reference Group measured Radiographic assessment
A summary of clinical outcome scoring systems method of gait assessment. Additionally, scoring
for pelvic fracture is provided in Tables 18-A1.1 systems may also incorporate a score for the radio-
18-A1.3. logical outcome rated by the clinician, others are
purely based on radiological criteria. Those using
radiological criteria are based on plain radiographs,
ACETABULAR FRACTURES and to date none has routinely utilized CT scan or
magnetic resonance technologies.
Scoring systems There is increasing evidence that patient-based out-
come measures, by means of patients reporting of
Several scoring systems have been developed to assess symptoms, are generally more reliable than those
the outcome of acetabular fractures, while others based on clinician scores. There are few studies avail-
have been adapted from outcome measures for hip able that have attempted to use such scoring systems,
arthroplasty. Some of the scoring systems attempt and indeed there are few specific systems available
to score the outcome following acetabular fracture for use in orthopaedic trauma patients (Tables
by means of purely clinical scores usually based 18.718.10). The recent development of a Muscu-
on multiple factors reported by the clinician and loskeletal Functional Assessment Score has added a
patient. These usually include an assessment of pain, validated and reliable scoring system for gen-
functional ability, range of movement and some eral orthopaedic patients, including trauma cases
04098-18.qxd
Table 18.7: Acetabular fracture: Clinical scoring systems based on clinicians evaluation
06/02/2004
Clinical scores Satisfactory (%) Mean score Score components Range Group studied Reference
14:36 PM
Mobility index Not studied Not stated Passive ROM 0 (poor)100 Post THR Gade (1947)
(good)
Not studied Not stated Passive ROM/Pain/ Not specified Post THR Sheperd (1954)
Function
Page 245
Merle dAubigne 74 Not stated Pain/ROM/ 13 (poor)18 All fractures Deo (2001)
Gait and (excellent) operated
X-ray
76 16 (range 518) Pain/ROM/Gait 13 (poor)18 All fractures Matta (1996)
(excellent) operated
76 Not stated Pain/ROM/Gait 13 (poor)18 All fractures de Ridder (1994)
(excellent)
84 Not stated Pain/ROM/Gait 13 (poor)18 All fractures Matta (1994)
(excellent) operated
85 Not stated Pain/ROM/Gait 13 (poor)18 All fractures Rice (2002)
(excellent) operated
Acetabular 86 Not known X All fractures Kebaish (1991)
fracture
Toronto hip Not stated 14.5 Pain/Mobility/Gait 0 (poor)18 Displaced Pennal (1980)
Acetabular Fractures
score (excellent) fractures
Not stated 16.5 Pain/Mobility/Gait 0 (poor)18 Undisplaced Pennal (1980)
(excellent) fractures
31.5 Not stated Clinical/Radiograph 0 (poor)18 All fractures Matta (1988a,b)
(excellent)
Harris hip score Not studied Not studied Pain/Function/ROM/ 0 (poor)100 Post THR Harris (1969)
Deformity (good)
245
04098-18.qxd
246
Table 18.7: Acetabular fracture: Clinical scoring systems based on clinicians evaluation continued
06/02/2004
Pelvic and Acetabular Fractures
Clinical scores Satisfactory (%) Mean score Score components Range Group studied Reference
14:36 PM
77.4 Not stated Pain/Function/ROM/ 0 (poor)100 All fractures Liebergall
Deformity (good) operated (1999)
Iowa hip Not studied Not studied Pain/Function/ROM/ 0 (poor)100 Post THR Larson (1963)
Page 246
score Deformity (good)
80 Not stated Pain/Function/ROM ExcellentPoor All fractures Matta (1986a, b)
Functional Not studied 22 (range 057) Physical/Psychological/ 0 (good)100 All fractures Borrelli (2002)
assessment Social (poor) operated
Gait analysis Complex Complex Kinetic/Temporal/ Complex analysis All fractures Borrelli
Kinematic operated (2002)
Other hip scores 53 Not stated Questionnaire ExcellentPoor All fractures Ragnarsson
operated (1992)
6474 Not stated Not known ExcellentPoor All fractures Chen (2000)
76 Not stated Clinical grading ExcellentPoor All fractures Letournel (1980)
76 Not stated AO Documentation Unknown All fractures Leutenegger
form (1999)
80 Not stated Pain/ROM/Gait/Work/ ExcellentPoor All fractures Rowe (1961)
Function
Not studied Not studied Pain/Movement/ 0 (poor)18 Post THR Judet (1952)
Walking (excellent)
Not studied Not studied Pain/Function/ROM 6 per category Bilateral hip Lazansky (1967)
pathology
Return to 71 Not studied Not analysed Not analysed All fractures Pennal (1980)
work
References 251
(Martin et al. 1996; Engelberg et al. 1996). This measures and the values determined by previous
outcome instrument comprising 100 self-reported studies, and this should both direct the reader to
health items has been recently utilized, for the first the relevant literature and also provide them with
time, to assess the outcome following acetabular some albeit semi-quantitative means of compar-
fractures (Borelli et al. 2002). ing the study results.
The appendices at the end of the chapter serve to
provide actual details of several commonly encoun-
tered outcome measure scoring systems, that may
COMPLICATIONS be useful to the reader, first in understanding the
previous study methodology and second, to act as a
High-energy acetabular fractures are associated source of outcome tools for future studies. As is evi-
with a multitude of complicating factors affecting dent, many of these outcome measures are based on
the bones, soft tissues and neurovascular elements. previous versions from earlier studies and therefore
In terms of the acetabulum and femoral head, com- may be subject to the same limitations namely
plications may include late-onset osteoarthrosis, that the majority are unvalidated and rely purely on
non-union, malunion, severity and degree of avascu- clinicians assessment data.
lar necrosis and the rate of conversion to total hip
replacement or fusion. The surrounding ligamento-
capsular, neurological and muscular structures can be REFERENCES
affected by heterotopic ossification, nerve injury and
weakness. Pelvic fracture
Details of acetabular clinical and radiological out-
come measures and scoring systems are listed in Alost, T., and Waldrop, R. D. (1997): Profile of geriatric
Tables 18-A2.118-A2.8, Fig. 18A2.1 and Tables pelvic fractures presenting to the emergency
18-A3.118-A3.3. department. Am J Emerg Med 15, 5768.
Biffl, W. L., Smith, W. R., Moore, E. E., Gonzalez, R. J.,
Morgan, S. J., Hennessey, T., Offner, P. J., Ray,
SUMMARY C. E., Francoise, R. J., and Burch, J. M. (2001):
Evolution of a multidisciplinary clinical pathway
Injuries to the pelvis and acetabulum should be for the management of unstable patients with
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The chapter outlines the types and incidence of major and Redelmeier, D. A. (1997): Long term outcomes
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power analyses prior to embarking on future studies. posterior internal fixation of unstable pelvic
The second aim of the chapter to establish whether fractures. J Trauma 27, 9981006.
validated and appropriate outcome measures exist Burgess, A. R., Eastridge, B. J., Young, J. W. R., Ellison,
has revealed that, indeed, few are currently avail- T. S., Ellison, P. S., Poka, A., Bathon, G. H., and
able. Recent advances in the design and utilization Brumback, R. J. (1990): Pelvic ring disruptions:
of patient-based outcome measures have yielded reli- effective classification system and protocols.
able and validated outcome tools but, to date, few J Traum-Inj Infect Crit Care 30, 84856.
have been applied to either of our fracture types. The Butland, R. J. A., Gross, E. R., Pang, J., Woodcock, A. A.,
third aim of the chapter, in assisting investigators to and Geddes, D. M. (1982): Two, six and twelve
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Pennal, G., and Massiah, K. (1980): Nonunion and patients treated with a trapezoid compression
delayed union of fractures of the pelvis. Clin frame. Clin Orthop 151, 739.
Orthop 151, 1249. Tile, M. (1982): Disruption of the Pelvic Ring.
Pohlemann, T., Bosch, U., Gansslen, A., and Tscherne, H. Presentation: Combined Meeting of English
(1994): The Hanover experience in management Speaking Orthopaedic Surgeons, South Africa.
of pelvic fractures. Clin Orthop 305, 69-80. Tile, M. (1988): Pelvic ring fractures: should they be
Pohlemann, T., Gansslen, A., Schellwald, O., Culemann, fixed? J Bone Joint Surg 70-B, 112.
U., and Tscherne, H. (1996): Outcome after Tornetta, P., and Matta, J. (1995): Long term follow up
pelvic ring injuries. Injury 27, 8318. of operatively treated posterior pelvic ring
Poole, G. V., and Ward, E. F. (1994): Causes of disruptions. Orthop Trans 19, Abstract.
mortality in patients with pelvic fractures. Tornetta, P., and Matta, J. (1996): Outcome of
Orthopaedics 17, 6916. operatively treated unstable posterior pelvic ring
Poole, G. V., Ward, E. F., Muakkassa, F. F., Hsu, H. S., disruptions. Clin Orthop 329, 18693.
Griswold, J. A., and Rhodes, R. S. (1991): Pelvic Tornetta, P., Dickson, K., and Matta, M. (1996):
fracture from major blunt trauma. Outcome is Outcome of rotationally unstable pelvic ring
determined by associated injuries. Ann Surg 213, injuries treated operatively. Clin Orthop 329,
5328. 14751.
Raf, L. (1966): Double vertical fracture of the pelvis. Torode, I., and Zieg, D. (1985): Pelvic fractures in
Acta Chir Scand 131, 298305. children. J Paediatr Orthop 5, 7684.
Ragnarsson, B., Olerud, C., and Olerud, S. (1993): Upperman, J. S., Gardner, M., Gaines, B., Schall, L.,
Anterior square plate fixation of sacroiliac and Ford, H. R. (2000): Early functional
disruption. Acta Orthop Scand 64, 13842. outcome in children with pelvic fractures.
Roberts, P., and Carnes, S. (1990): The Orthopaedic J Paediatr Surg 35, 10025.
Scooter: an energy saving aid for assisted Van den Bosch, E. W., Van der Kleyn, R.,
ambulation. J Bone Joint Surg 72-B, 6201. Hoegervorst, M., and Van Vugt, A. B. (1999):
Rothenberger, D. A., Fischer, R. P., Strate, R. G., Functional outcome of internal fixation for pelvic
Velasco, R., and Pery, J. F. (1978): The mortality ring fractures. J Trauma 47, 36571.
associated with pelvic fractures. Surgery 84, Van Gulik, T., Raaymakers, E., and Broekhuizen, A.
35661. (1987): Complications and late therapeutic
Schwartz, N., Posch, E., Mayr, J., Fischmeister, F. M., results of conservatively managed unstable
Schwartz, A. F., and Ohner, T. (1998): Long term pelvic ring disruptions. Neth J Surg 39, 1758.
results of pelvic ring fractures in children. Injury Van-Veen, I. H., Van-Leeuwen, A. A., Van-Popta, T.,
29, 4313. Van-Luyt, P. A., Bode, P. J., and Van-Vugt, A. B.
Semba, R., Yasukawa, K., and Gustillo, R. (1983): (1995): Unstable pelvic fractures a retrospective
Critical analysis of results of 53 malgaigne analysis. Injury 26, 815.
fractures of pelvis. J Trauma 23, 5357. Weis, E. B., Jr. (1984): Subtle neurological injuries in
Singh, S. J., Morgan, M. D. L., Scott, S., Walters, D., pelvic fractures. J Trauma 24, 9835.
and Hardman, A. E. (1992): Development of
a shuttle walking test of disability in patients
with chronic airways obstruction. Thorax 47, Acetabular fractures
101924.
Slatis, P., and Huittinen, V. M. (1972): Double vertical Armstrong, J. (1948): Traumatic dislocation of the hip.
fractures of the pelvis. Acta Chir Scand 138, J Bone Joint Surg 30-B, 430.
799807. Borrelli, J. G. C., Ricci, W., Wagner, J., and Engsberg, J.
Slatis, P., and Karaharju, E. (1980): External fixation of (2002): Functional outcome after isolated
unstable pelvic fractures: experiences in 22 acetabular fractures. J Orthop Trauma 16, 7381.
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Rowe, C. R., and Lowell, J. D. (1961): Prognosis of Upadhyay, S. M. A. (1981): The long-term results of
fractures of the acetabulum. J Bone Joint Surg traumatic posterior dislocation in the hip. J Bone
43-A, 3059. Joint Surg 63-B, 54851.
Schafer, S. S. L., Anglen, J., and Childers, M. (2000): Urist, M. (1948): Fracture-dislocation of the hip joint.
Heterotopic ossification in rehabilitation patients J Bone Joint Surg 30-A, 699727.
who have had internal fixation of an acetabular Woods, R., OKeefe, G., Rhee, P., Routt, M., and Maier,
fracture. J Rehabil Res Dev 37, 38993. R. (1998): Open pelvic fracture and faecal
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35463. Acetabular fractures: long-term follow-up of
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04098-18.qxd 06/02/2004 14:36 PM Page 256
APPENDIX
Reprinted from Pennal, G., and Massiah, K. (1980): Nonunion and delayed union of fractures of the pelvis. Clin Orthop 151, 1249.
Appendix 257
Table 18-A1.2: Majeed Pelvic Outcome Score continued
Reprinted from Majeed, S. A. (1989): Grading the outcome of pelvic fractures. J Bone Joint Surg 71-B, 3046, with permission.
Subjective pain Average of resting and ambulation scores on a scale of 1 (no pain) to 10 (severe pain)
12 points 4
34 points 3
56 points 2
78 points 1
910 points 0
Trendelenberg
Negative 1
Positive 0
Tenderness
No sacral or pubic tenderness 2
Sacral or pubic tenderness 1
Sacral and Pubic tenderness 0
Abduction/adduction
Bilateral thigh abduction and adduction 5/5 1
Thigh abduction or adduction 5/5 0
Range of motion
Normal hip and trunk range of motion 1
Trunk flexion 90, hip flexion 90 or 20
difference in hip internal or external rotation when
compared with contralateral side 0
Reprinted from Cole, J. D., Blum, D. A., and Ansel, L. J. (1996): Outcome after fixation of unstable posterior pelvic ring injuries.
Clin Orthop 329, 16079.
04098-18.qxd 06/02/2004 14:36 PM Page 259
Appendix 259
80
Mobility (19)
0.1
30 0.2
Housework (9)
0.3
Employment/work (3) Lateral rotation Adduction. Medial rotation
0 30 multiply by 0.3 Extension
Leisure/recreation (4) 30 80 multiply by 0.1 Multiply by 0.2
Family relationships (10)
Figure 18-A2.1 Mobility Index.
Cognition/thinking (4)
Reprinted from Gade, H. (1947): A contribution to the surgical
Emotional adjustment (21) management of osteoarthritis of the hip joint: a clinical study. Acta
Chir Scand 120(Suppl.) 3745.
Reprinted from Martin, D. et al. (1996): The development of a
musculoskeletal extremity health status instrument: the
Musculoskeletal Functon Assessment instrument. J Orthop Res
14, 17381, with permission from the Orthopaedic Research
Society.
Reprinted from Epstein, H. (1973): Traumatic dislocations of Pain, Right Left (12)
the hip. Clin Orthop 92, 11421.
Function (21)
Mobility, Right Left (67)
Table 18-A2.4: Harris Hip Score (Total 100) Table 18-A2.7: Larson Hip Disability Rating Scale (Total 100)
Appendix 261
Table 18-A2.8: Matta Clinical Grading Criteria
Clinical
No symptoms; Minor complaints; Discomfort intermittent; Constant pain; frequent
no medication; no medication; relieved by rest and salicylates; medication; disturbing
full motion; no 25 per cent limitation mild sciatic-nerve symptoms; sciatic-nerve symptoms;
limp; no support; of motion; no limp; no 50 per cent limitation of 75 per cent limitation
sustained activities; support; sustained motion; intermittent limp; of motion; constant
all sports; returned activities; all sports; occasional support; adjustment limp; activities limited;
to original job returned to original job of work in original job full-time support; not
able to work
Anatomical
Normal joint space: Fractured fragments Mild-to-moderate narrowing Very narrow joint
no head changes have healed with a of the joint space; early space; advanced
smooth congruous arthritic changes and osteophyte arthritic changes;
articulating surface; formation; mild changes in sclerosis and spur
no head changes; contour of the ferroral head; formation; definite
less-than-normal moderate myositis ossificans avascular necrosis of
anatomy; adequate the femoral head with
joint space; mild cystic changes;
myositis ossificans advanced myositis ossificans
Reprinted from Rowe, C. R., and Lowell, J. D. (1961): Prognosis of fractures of the acetabulum. J Bone Joint Surg 43-A, 3059.
04098-18.qxd 06/02/2004 14:36 PM Page 262
Reprinted from Epstein, H. (1973): Traumatic dislocations of the hip. Clin Orthop 92, 11421.
Reprinted from Matta, J. (1996): Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively
within three weeks after the injury. J Bone Joint Surg 78-A, 163245.
04098-19.qxd 06/02/2004 14:37 PM Page 263
19
Femoral head and neck and the hip joint
Martyn J. Parker and Andrew Pearson
INTRODUCTION MORTALITY
The effect of treatment for a hip condition may Whilst this outcome has less relevance to those con-
be assessed by a substantial number of outcome ditions associated with a low mortality, for other
measures. These vary from subjective assessment (e.g. conditions such as hip fracture this can be con-
pain), objective assessment (e.g. range of movement), sidered as a key outcome measure. Mortality is cer-
and radiographic changes through to composite tainly a definite outcome measure, but variations in
measures such as hip scores. The outcome measures reported figures may be due to a number of reasons
used will be dictated by the nature of the condition related to data collection. These include:
being studied and the general health of the patient.
For example, the assessment of those patients after Is it a consecutive series of patients or a selected
series?
an elective hip replacement is more likely to be prac-
tical in a follow-up clinic, and long-term follow-up What is the definition of cases to be included
is feasible. Conversely, for the elderly frail patient within the series? For example, patients
who sustains a hip fracture, repeated clinic follow- between certain age ranges, or with a certain
up visits are impractical and long-term follow-up is type of condition.
affected by the high underlying mortality in this
group of patients.
How many cases were lost to follow-up? It is
incorrect to assume that the mortality in those
The different outcomes that may be used can be
lost to follow-up is the same as in the whole
considered under the following headings:
group.
Mortality What is the time period to consideration of
mortality? Is it hospital mortality, three, six or
Pain
12 months after surgery, or long-term?
Hip movements and deformity
Are the deaths related to the hip condition or to
Functional outcomes other causes? It may be more appropriate to
look at any specific cause of death, for example
Hip scores
pulmonary embolism.
General health indicators
06/02/2004
Table 19.2: Studies determining outcome scores and their findings
14:37 PM
Subjects, intervention,
outcomes, inclusion Methodology, rigor,
Outcome measure Study design and exclusion criteria selection, bias Results Comment
Page 266
Bellamy et al. (1988). Prospective Patients: n 30 with Randomization: N/A Reliability: WOMAC is a reliable,
Validation study of primary OA of the hip or Selection: Reliability valid and responsive
WOMAC: a health status knee 30 consecutive coefficient 0.80 multi-dimensional,
instrument for measuring Intervention: Assessed patients, 14M, 16F Validity: Validity self-administered
clinically important day before surgery and then Rigor: Compared confirmed for pain, questionnaire.
patient-relevant at 6 weeks, 3 months and to Doyle, Lequesne, stiffness and physical
outcomes following 6 months post-operatively Bradburn indexes and function.
total hip by same interviewer social component
or knee arthroplasty Inclusion and exclusion of the McMaster
in osteoarthritis. criteria: health index
All patients ambulatory, questionnaire.
unrestricted by any
co-morbidity, for primary
surgery, attend the
orthopaedic clinic
Sderman and Malchau Retrospective Patients: n 58 at 210 Randomization: Yes Reliability and The use of WOMAC
(2000) Validity and reliability years following THA Validity: All three after THA is to be
of Swedish WOMAC Intervention: All patients tests were found to encouraged.
osteoarthritis index: a filled in WOMAC, SF-36 be highly reliable
self-administered and NHP scores and and valid.
disease-specific repeated at 4 weeks.
questionnaire vs.
generic instruments
[SF-36 and Nottingham
Health Profile (NHP)]
04098-19.qxd
Fitzpatrick et al. (2000). The Survey of patients Patients: n 7151 in 143 Randomization: No Reliability:
value of short and simple undergoing hospitals in three NHS All patients Reliability
06/02/2004
measures to assess primary THA English regions accounted coefficient 0.88.
outcomes for before operation Intervention: Patient- for: Yes Validity: Validity
patients of total hip and 3 and 12 completed questionnaires, Potential for bias: is confirmed, despite
replacement surgery. months after surgeons questionnaire Older patients and the relatively small
14:37 PM
Oxford Hip Score surgery and ASA classification those with major number of
for 5038 patients. health problems questions in
were more likely not the score.
to complete the form.
Page 267
Dawson et al. (1996) 20 patients attending Patients: n 220 Randomization: N/A Reliability: A short practical
Questionnaire on the an out-patient clinic consecutive, early 1994 Reliability valid and reliable
perceptions interviewed regarding Intervention: coefficient 0.8 questionnaire which is
of patients their hips resulted Patients Validity: The sensitive to clinically
about total hip in a questionnaire. completed the results important changes.
replacement. Prospective questionnaire compared well
Oxford Hip Score study developed pre-operatively with the proven
from this and at 6 months SF-36, especially
questionnaire. post-operatively, regarding physical
as well as the SF-36. function and pain.
Alonso et al. (2000). The Prospective Patients: n 131 Randomization: N/A Reliability: Comparison with the
pain and function of Intervention: Patients All patients Reliability Harris hip score or
the hip (PFH) completed the accounted coefficient 0.8 WOMAC might have
scale: a patient-based questionnaire and for: Yes Validity: Not been more
instrument for measuring NHP questionnaire demonstrated, appropriate.
outcome after total hip pre-THA, and at but stated by
replacement. 3 and 12 months authors.
post-operatively.
Hip Scores
267
04098-19.qxd 06/02/2004 14:37 PM Page 268
Total hip replacement reductions into perfect and imperfect. The imperfect
reductions were subdivided into groups with the
A number of different methods have been used to head centred, with protrusio, with loss of paral-
assess the radiographic features after arthroplasty. lelism, and with development of the secondary con-
For the femoral component, Gruen et al. (1979) gruent centre medial to the normal acetabulum.
divided the femoral stem into thirds, as viewed on Matta and Merrit (1988) subsequently described
both antero-posterior and lateral radiographs. a method of assessing reduction whereby a displace-
These areas were then analysed for acrylic cement ment of 3 mm on any of the three standard
fracture and radiolucency at the stemcement and X-radiography views was considered unsatisfactory,
cementbone interface. Radiographs were evalu- a displacement of 3 mm was rated satisfactory,
ated chronologically to assess loosening as mani- and an anatomic reduction was referred to as
fested by progressive changes in the width or length displacement of 1 mm.
of the radiolucent zones; the appearance of scler-
otic bone reaction; widening of the acrylic cement
fracture gap; and fragmentation of the cement and Heterotrophic ossification
gross movement of the femoral component.
DeLee and Charnley (1976) described a method Booker and colleagues (Booker et al. 1973) classified
of quantifying radiological demarcation of cemented heterotrophic bone formation into four groups from
sockets in total hip replacement. The width of the an antero-posterior radiographic viewpoint:
radiolucent zone around the cement was measured
on radiographs without correction for the 10 per cent Class 1: Islands of bone within soft tissues
about the hip.
magnification. The width was divided into four
groups: 0.5 mm; 1 mm; 1.5 mm; and 1.5 mm. Class 2: Bone spurs from the pelvis or proximal
As the width varied, the widest dimension was end of the femur, leaving at least 1 cm between
recorded. In addition to the width of demarcation, opposing bone surfaces.
its distribution around the circumference of the
socket was categorized into three zones: Class 3: Bone spurs from the pelvis or proximal
end of the femur, reducing the space between
Type I being lateral to a vertical line drawn opposing bone surfaces to 1 cm.
through the centre of the acetabulum
Class 4: Apparent bone ankylosis of the hip.
Type III being below a horizontal line to run Maloney et al. (1991) later modified this assess-
through the centre of the acetabulum; and ment method.
Type II being the remainder.
Type 1: Normal head and centre-edge angle. Slip severity can be classified radiographically by
several methods. These are based on either the
Type 2: Abnormal head, normal centre-edge
amount of capital displacement, or on the angular
angle.
measurement of the epiphysis relative to either the
Type 3: Residual dysplasia with reduced centre- femoral neck or shaft (Cohen et al. 1986). The clas-
edge angle. sifications divide the slip into mild, moderate and
severe. In a mild slip, the epiphysis is displaced less
Type 4: Subluxation.
than one-third of the neck width, or if the head-
neck angle is less than 30; in a moderate slip the
Type 5: Subluxation severe with wandering
acetabulum. displacement is between one-third and one-half of
the neck width, or the head-neck angle is between
Type 6: Complete dislocation. 30 and 50; in a severe slip the displacement is
04098-19.qxd 06/02/2004 14:37 PM Page 271
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no value for assessing the results of proximal reliability of Swedish (WOMAC) osteoarthritis
femoral fracture treatment. Int Orthop 21, 2624. index: a self-administered disease-specific
Parker, M. J., Myles, J. W., Anand, J. K., and Drewett, R. questionnaire vs. generic instruments (SF36 and
(1992): Cost-benefit analysis of hip fracture NHP). Acta Orthop Scand 71, 3946.
treatment. J Bone Joint Surg 74-B, 2614. Sderman, P., and Malchau, H. (2001): Is the Harris hip
Parker, M. J., and Palmer, C. R. (1993): A new mobility score system useful to study the outcome of total
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Parker, M. J., and Pryor, G. A. (1993): Hip Fracture (1957): Replacement of the femoral head by
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20
Tibial and femoral shafts
Badri Narayan, Raman V. Kalyan and David R. Marsh
Table 20.1: Comparison of the commonly used Extremity Severity Scores (after Bosse et al. 2001, with permission)
Age
Shock
Warm ischaemia time
Bone injury
Muscle injury
Skin injury
Nerve injury
Deep vein injury
Skeletal/soft-tissue injury
Contamination
Time to treatment
1
Mangled Extremity Severity Score (Johansen et al. 1990).
2
Limb Salvage Index (Russell et al. 1991).
3
Predictive Salvage Index (Howe et al. 1987).
4
Nerve Injury, Ischemia, Soft-Tissue Injury, Skeletal Injury, and Age of Patient Score (McNamara et al. 1994).
5
Hannover Fracture Scale-1997 (Sudkamp et al. 1993).
04098-20.qxd 06/02/2004 14:37 PM Page 280
MECHANICAL CRITERIA
BONE HEALING AND
A fully united fracture will be stable to bending
COMPLICATIONS
and/or torsion. The ability to resist such a force will
However much they accept the importance of a remain the gold standard of a healed fracture for
holistic view of fracture patients and their out- purposes of experimental study in animal models,
comes, surgeons will always regard the primary but is obviously difficult to carry out in the clinical
goal of their efforts as being the achievement of setting. A bending stiffness of 15 Nm per degree in
bone union without complications. Assurance of the sagittal plane was described as being diagnostic
healing is to be distinguished from speed of union, of union across a tibial fracture treated by external
and the former would generally be regarded as fixation (Richardson et al. 1994). This particular
more important in high-energy injuries. The need instrumented method of diagnosing union cannot be
for secondary intervention to achieve union is also applied to fractures treated by any method other
an important outcome of the primary treatment. than half-pin external fixation or conservatively and
None of these concepts can be utilized without a is very difficult to apply to a femoral fracture.
definition of fracture union and a means of estab- Kay et al. (1992) and Marsh (1998) also used bend-
lishing that it has occurred. ing strength to assess union across non-operatively
This subsection deals first with the measurement, treated tibial shaft fractures, and reported good cor-
including progress of fracture healing in the tibia relation between mechanical behaviour and the state
and femur. This is followed by a discussion on the of healing of tibial fractures.
two important complications of fracture treatment, It is tempting to try to reproduce manually a
malunion and infection. bending force corresponding to 15 Nm per degree
in the out-patient setting to check for union across
tibial fractures, but an attempt to do this proved
consistently unsuccessful (Webb et al. 1996).
Measures of fracture healing
(and non-union) RADIOLOGICAL CRITERIA
The judgement of union from radiographs forms
The identification of completion of union across a the mainstay of clinical practice; unfortunately, this
femoral or tibial diaphyseal fracture, though super- remains a contentious issue. The correlation between
ficially simple, remains a vexed issue. radiological appearances and mechanical strength
04098-20.qxd 06/02/2004 14:37 PM Page 281
Table 20.2: Assessment of fracture healing on radiographs. Reprinted from Hammer et al. (1985)
Radiological assessment
Table 20.6: Functional evaluation of the knee following tibial shaft fractures (after Toivanen et al. 2002)
Score
Parameter 0 1 2 3
Table 20.7: Summary of the knee scores used in tibial shaft fractures
Table 20.8: Summary of the ankle scores used in tibial shaft fractures
Result
Malalignment
Varus/valgus 5 5 10 10
Procurvatum/recurvatum 5 10 15 15
Internal rotation 5 10 15 15
External rotation 10 15 20 20
Shortening (in cm) 1 2 3 3
Range of motion (knee)
Flexion 120 120 90 90
Extension deficit 5 10 15 15
Pain or swelling None Sporadic, Minor Significant Severe
developed during that time, this system suffers from Assessment of the knee following treatment of
one major inadequacy namely that a patient may femoral fractures has usually concentrated on
fall into different groups for different criteria, thus range of motion (Thoresen et al. 1985). With the
causing ambiguity in the interpretation of the final increasing popularity of retrograde femoral nailing,
outcome. In addition, it is felt that the differences in assessment of subtle functional deficits in the knee,
rotation of 5 are difficult to measure and should using established scoring systems, may well be an
not be used to stratify results. Interestingly, this issue in the long term following this procedure,
method of assessing outcome has been recently used particularly following experimental investigations
in a peer-reviewed publication (Arazi et al. 2001). (ElMaraghy et al. 1998) which have shown a
Also during 1985, another report was published decrease in perfusion of the cruciate ligaments fol-
which described a scoring system to evaluate the lowing retrograde nailing. Short-term follow-up
results of femoral shaft fractures (Cheng et al. (Ostrum et al. 2000) has shown no increase in knee
1985). This system, which was very similar to that symptoms with retrograde nailing.
of Thoresen and colleagues, has (to the best of our
knowledge) not been used in peer-reviewed papers
after its initial appearance. AMBULATION AS A COMPONENT
A more recent report (Bain et al. 1997) brought OF GENERIC OUTCOME SCORES
attention to the not insignificant morbidity around
the hip following antegrade nailing. Although this Generic health status scores (see Chapter 6) are
study included patients who had undergone closed well established in the assessment of orthopaedic
femoral shortening as well as nailing for fractures, interventions. Many publications now combine the
the morbidity which included heterotopic use of a regional disease-specific measure, and a
ossification and abductor weakness was con- generic measure, such as the SF-36, and studies such
sidered to be consequent on the nailing procedure as those of Dogra et al. (2002) demonstrate the
rather than the injury. Hip scores combined with strong correlation between the two.
generic measures of outcome have not been used to The principal advantage of generic scores is
assess function after femoral fractures in adults. that they afford an estimate of the importance or
04098-20.qxd 06/02/2004 14:37 PM Page 289
References 289
salience to the patient of any deficit in locomotor fractures should ideally be in the context of a well-
function. This allows comparison with health prob- conducted prospective randomized trial. The use of
lems in other body systems and pathologies. It also the CONSORT flowsheet (Moher et al. 2001)
raises the possibility of the use of only a generic permits a systematic analysis of the flow of patients
score as a universal outcome measure, rather than through such trials.
having to use different regional scores for each In spite of its weaknesses, the AO-OTA classifica-
anatomical area of the body. tion provides a basis for morphological comparison
However, the weakness of the generic instrument of bony injuries. For the accompanying soft-tissue
may be that it is less sensitive to subtle changes in injury too often ignored the Tscherne grading sys-
regional function, and thus provides only a poor dis- tem correlates best with outcome in tibial shaft frac-
criminator in studies of musculoskeletal outcome. tures. Energy of injury is a very important variable
Furthermore, the generic score reflects the impact of for stratification, as it correlates with time for union.
all the patients problems, so that the measure of the The ideal mangled extremity score should be both
consequences of any one injury under study is con- sensitive and specific and, to date, none has proved
taminated by noise. Indeed the effect of all pre-injury to be so. The LEAP study will hopefully provide
morbidities will be registered, although this can more answers to this problem.
to some extent be mitigated by obtaining a quasi- In assessing fracture healing per se, mechanical
baseline score by asking the patient, shortly after testing would be ideal, as interpretation of radio-
injury, to complete a questionnaire on the basis of graphs is subject to variation. However, the prob-
how they felt just before the injury occurred. lem of mechanical assessment of fractures that have
This contradiction is inescapable. Measures such been nailed remains unsolved. The advent of digital
as the Musculoskeletal Function Assessment Ques- radiographic techniques may help to quantify cal-
tionnaire (Martin et al. 1997) and the Short Muscu- lus, following further research, and thus allow
loskeletal Function Assessment Questionnaire quantification of at least the bone regeneration, if
(Swiontkowski et al. 1999), designed to enhance the not structural restitution. The minimum require-
sensitivity to musculoskeletal impairments, immedi- ment is that criteria used for the definition of time
ately sacrifice the advantage of comparability to dis- to union should be explicitly stated in all reports.
abilities produced by impairments in other body Malunion of a lower-limb fracture is only as
systems. important as its effect on function and aesthetics.
The only solution is to use a combination of Artificial figures to define a malunion are often
disease-specific and generic scores, the former to contradictory. The true consequences of a mal-
achieve musculoskeletal sensitivity, the latter to union its effects on the neighbouring joints can
achieve a comparative measure of holistic impact. only be assessed by long-leg radiographs and meas-
urement of the mechanical axis.
Outcome measures should include regional and
SUMMARY AND CONCLUSION generic measures of function, rather than one of
these in isolation. Though seemingly interrelated,
Outcome measures for lower-limb function follow- the use of both types of outcome will permit a more
ing trauma are continuing to evolve. A few have comprehensive analysis of results.
been used more commonly than others, but this in
itself does not mean they are necessarily better.
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04098-20.qxd 06/02/2004 14:37 PM Page 294
APPENDIX
Factor Score
Bone loss
None 0
2 cm 1
2 cm 2
Skin injury
None 0
4 circumference
1
1
1
4 12 circumference 2
1
2 34 circumference 3
4 circumference
3
4
Muscle injury
None 0
14 circumference 1
1
412 circumference 2
1 3
2 4 circumference 3
4 circumference
3
4
Wound contamination
None 0
Partly 1
Massive 2
Deperiostation
No 1
Yes 2
04098-20.qxd 06/02/2004 14:37 PM Page 295
Appendix 295
Table 20-A.1: Hannover Fracture Scale 98 (Krettek et al. 2001, reprinted
with permission from Elsevier) continued
Factor Score
Local circulation
Normal pulse 0
Capillary pulse only 1
Ischaemia 4 hours 2
Ischaemia 48 hours 3
Ischaemia 8 hours 4
Systemic circulation (systolic blood pressure)
Constantly 100 mmHg 0
Until admission 100 mmHg 1
Until operation 100 mmHg 2
Constantly 100 mmHg 3
Neurology
Palmar-plantar yes 0
Absent sensation 1
Finger-toe yes 0
Active motion: no 1
Table 20-A.2: The Tscherne grading system for soft-tissue injury. Reprinted from Oesterne and Tscherne (1984)
Factor Score
Skeletal/soft-tissue injury
Low-energy (stab, fracture, civilian gunshot wound) 1
Medium-energy (open or multiple fractures) 2
High-energy (shotgun or military gunshot wound, crush) 3
Very high-energy (above plus gross contamination) 4
Limb ischaemia
Pulse reduced or absent but perfusion normal 1*
Pulseless, diminished capillary refill 2*
Patient is cool, paralysed, insensate, numb 3*
Shock
Systolic blood pressure always 90 mmHg 0
Systolic blood pressure transiently 90 mmHg 1
Systolic blood pressure persistently 90 mmHg 2
Age
30 years 0
3050 years 1
50 years 2
Table 20-A.4: Iowa Knee Evaluation (Merchant and Dietz 1989, with permission)
Appendix 297
Table 20-A.4: Iowa Knee Evaluation (Merchant and Dietz 1989) continued
Appendix 299
Table 20-A.6: The Ankle and Hindfoot Score of the American Orthopaedic Foot and Ankle Society. Reprinted from Kitaoka et al. (1994)
21
The knee
Amir W. Hanna
Method of Total
Tool Year Type Tool domain administration Form A B C D score
A Validity; B Reliability; C Responsiveness to change; D Usage; MFA Musculo-skeletal functional assessment questionnaire.
This tool is specific enough (Harcourt et al. 2001); * Not reliable (Liow et al. 2000); Not valid (Stucki et al. 1998); Not sensitive to
change for knee disorders (Kreibich et al. 1996); a Dunbar et al. (2000); b Lingard et al. (2001).
04098-21.qxd 07/02/2004 17:56 PM Page 305
Method of Total
Tool Year Type Original use administration Form A B C D score
A Validity; B Reliability; C Responsiveness to change; D Usage; ACL Anterior cruciate ligament; OA Osteoarthritis;
PF Patellofemoral; VAS Visual Analogue Scale. a Barber-Westin et al. (1999); b Marx et al. (2001); c Risberg et al. (1999).
04098-21.qxd 07/02/2004 17:56 PM Page 309
References 309
of the Fulkerson score. The only specific outcome that subjective assessment using a comprehensive sys-
tool for meniscal injuries was developed by Tapper tem such as the ADLS, KOOS or ACL-QOL (when
and Hoover (1969) (Fig. 21-A.20). No specific ques- rigorously validated) produces results that are com-
tions were published, but rather a classification of parable with those of the Cincinnati scoring system.
results from their original report. Radiological assess- For patellofemoral and meniscal disorders, a vali-
ment remained part of the overall assessment. New dated self-administered tool is ideal. Hence, ADLS or
tools such as KOOS and ADLS were shown to be KOOS would be the best buy.
valid for assessing these disorders. For fractures around the knee, a combination of
objective subjective and radiological scoring system
BEST BUY is needed for short-term follow-up. The only disease-
The use of either ADLS or KOOS is recommended specific instrument available are the Rasmussen cri-
for assessing the outcome of meniscal surgery. teria, though subjective assessment will suffice for
long-term results. As yet, there is no best buy, but
the use of the WOMAC is recommended.
FRACTURES AROUND THE KNEE Although the principle of using a universal knee
outcome tool for all knee disorders is appealing,
Very few outcome measures have been developed for such a system is unlikely to be practicable due to
fractures around the knee. The Rasmussen criteria the differences in demands of patients from each
(Rasmussen 1973) was designed to evaluate the disease group.
results of treating tibial plateau fractures (Fig. 21-
A.21), and this has been widely used but never val-
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A rationale for assessing sports activity levels Friedman, M. J. (1995): Critical analysis of knee
and limitation in knee disorders. Clin Orthop ligament rating scales. Am J Sports Med 23, 6607.
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D. L. (1983): The symptomatic anterior cruciate- The use of generic, patient-based health assessment
deficient knee. Part I: The long-term functional (SF-36) for evaluation of patients with anterior
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Appendix
RIGHT LEFT
Post Post
Pre 6m 1 2 3 4 Pre 6m 1 2 3 4
1. PAIN 30 points
1. No pain at any time 30
2. No pain on walking 15
3. Mild pain on walking 10
4. Moderate pain on walking 5
5. Severe pain on walking 0
6. No pain at rest 15
7. Mild pain at rest 10
8. Moderate pain at rest 5
9. Severe pain at rest 0
2. FUNCTION 22 points
A1. Walking and standing unlimited 12
2. Walking distance of 5 to 10 blocks and
standing ability intermittent
(more than 1/2 hour) 10
3. Walking 1 to 5 blocks and standing
ability up to 1/2 hour 8
4. Walk less than 1 block 4
5. Can't walk 0
B1. Climb stairs 5
2. Climb stairs with support 2
3. Transfer activity 5
4. Transfer activity with support 2
3. ROM 18 points
1. 1 point for each 8 of arc of
motion-maximum of 18 points
4. MUSCLE STRENGTH 10 points
1. Good Can't break quadriceps power 10
2. Good Can break quadriceps power 8
3. Fair Moves through arc of motion 4
4. Poor Can't move through arc of motion 0
5. FL DEFORMITY 10 points
1. No deformity 10
2. Few degrees 8
3. 5 10 5
4. 11 or more 0
6. INSTABILITY 10 points
1. N 10
2. Mild 0 5 8
3. Moderate 615 5
4. Severe 16 or more 0
Remarks: Subtract 1 point for using a cane, 2 points for 1 crutch and 3 points for 2 crutches. Two points for 5 of extension lag,
3 points for 10 and 5 points for 15 or more. One point for 5 valgus and varus deformities.
Figure 21-A.1 Knee disability assessment. Developed for follow-up evaluations of total knee replacement. Reprinted from Ranawat et al. (1976).
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Figure 21-A.2 Knee function assessment chart. Reprinted from Aichroth et al. (1978).
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Figure 21-A.3 New Jersey Orthopaedic Hospital Knee Evaluation System. Reprinted from Buechel et al. (1982).
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Patient category
A. Unilateral or bilateral (opposite knee successfully replaced)
B. Unilateral, other knee symptomatic
C. Multiple arthritis or medical infirmity
Deductions (minus)
Flexion contracture
510 2
1015 5
1620 10
20 15
Extension lag
10 5
1020 10
20 15
Alignment
510 0
0 4 3 points each degree
1115 3 points each degree
Other 20
Total deductions
Knee score
(If total is a minus number, score is 0)
Figure 21-A.4 Knee Score. Rationale of American Knee Society (KSS). Reprinted from Insall et al. (1989).
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Pre-operative
Total group ACL ACL Men Men Men CD CD
KOOS items n 142 n 12 n 23 n 49 n 27 n 18 P-value
Pain
P1. How often is your knee painful? 0.12
What degree of pain have you experienced
the last week, when ?
P2. Twisting/pivoting on your knee 0.7
P3. Straightening knee fully 0.09
P4. Bending knee fully 0.3
P5. Walking on flat suface 0.004
P6. Going up or down stairs 0.001
P7. At night while in bed 0.001
P8. Sitting or lying 0.001
P9. Standing upright 0.002
Symptoms
S1. How severe is your knee stiffness after first 0.07
wakening in the morning?
S2. How severe is your knee stiffness after sitting, 0.007
lying or resting later in the day?
S3. Do you have swelling in your knee? 0.03
S4. Do you feel grinding, hear clicking or any 0.07
other type of noise when your knee moves?
S5. Does your knee catch or hang up when moving? 0.5
S6. Can you straighten your knee fully? 0.4
S7. Can you bend your knee fully? 0.8
Activities of daily living
What difficulty have you experienced in the last week ?
A1. Descending stairs 0.01
A2. Ascending stairs 0.11
A3. Rising from sitting 0.001
A4. Standing 0.2
A5. Bending to floor/pick up an object 0.11
A6. Walking on flat surface 0.01
A7. Getting in /out of car 0.03
A8. Going shopping 0.003
A9. Putting on socks/stockings 0.08
A10. Rising from bed 0.001
A11. Taking off socks/stockings 0.11
A12. Lying in bed (turning over, maintaining knee position) 0.001
A13. Getting in /out of bath /shower 0.17
A14. Sitting 0.001
A15. Getting on /off toilet 0.001
A16. Heavy domestic duties (shovelling snow, scrubbing 0.01
floors etc.)
A17. Light domestic duties (cooking, dusting etc.) 0.02
Sport and recreation function
What difficulty have you experienced in the last week ?
Sp1. Squatting 0.6
Sp2. Running 0.6
Sp3. Jumping 0.16
Sp4. Turning/twisting on your injured knee 0.7
Sp5. Kneeling 0.3
Knee-related quality of life
Q1. How often are you aware of your knee problems? 0.18
Q2. Have you modified your life style to avoid potentially 0.6
damaging activities to your knee?
Q3. How troubled are you with lack of confidence in 0.13
your knee?
Q4. In general, how much difficulty do you have with 0.4
your knee?
The mean score can range from 0 to 4. To simplify interpretation the mean scores are categorized into three groups. A mean score of 2, indicating
on average at least moderate problems with the item, is indicated by (). A mean score of
1, indicating subjects reporting on average at the most
mild problems with the item, is marked by (). Items not marked by () or (), have a mean score of 1 and 2, indicating mild to moderate
problems with the item. P-values are given for comparisons of reported scores with the Kruskal-Wallis test across all groups.
Figure 21-A.5 Mean KOOS scores of each single item for the total group, and for the subgroups isolated ACL-injury (ACL), ACL-injury
with associated meniscus injury (ACL + Men), isolated meniscus injury (Men), meniscus injury with associated cartilage damage
(Men + CD), and isolated cartilage damage (CD). Reprinted from Roos et al. (1998).
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Instructions: The following questionnaire is designed to determine the symptoms and limitations that you experience because
of your knee while you perform your usual daily activities. Please answer each question by checking the statement that
best describes you over the last 1 to 2 days. For a given question, more than one of the statements may describe you, but
please mark ONLY the statement that best describes you during your usual daily activities.
Symptoms: 6. To what degree does buckling of your knee affect your
1. To what degree does pain in your knee affect your daily daily activity level?
activity level? _5_ I never have buckling of my knee.
_5_ I never have pain in my knee. _4_ I have buckling of my knee, but it does not affect
_4_ I have pain in my knee, but it does not affect my my daily activity level.
daily activity. _3_ Buckling affects my activity slightly.
_3_ Pain affects my activity slightly. _2_ Buckling affects my activity moderately.
_2_ Pain affects my activity moderately. _1_ Buckling affects my activity severely.
_1_ Pain affects my activity severely. _0_ Buckling of my knee prevents me from performing
_0_ Pain in my knee prevents me from performing all all daily activities.
daily activities. 7. To what degree does weakness or lack of strength of
your leg affect your daily activity level?
2. To what degree does grinding or grating of your knee
_5_ My leg never feels weak.
affect your daily activity level?
_4_ My leg feels weak, but it does not affect my daily
_5_ I never have grinding or grating in my knee.
activity.
_4_ I have grinding or grating in my knee, but it does not
_3_ Weakness affects my activity slightly.
affect my daily activity.
_2_ Weakness affects my activity moderately.
_3_ Grinding or grating affects my activity slightly.
_1_ Weakness affects my activity severely.
_2_ Grinding or grating affects my activity
_0_ Weakness of my leg prevents me from performing
moderately.
all daily activities.
_1_ Grinding or grating affects my activity severely.
_0_ Grinding or grating in my knee prevents me from Functional Disability with Activities of Daily Living
performing all daily activities.
8. How does your knee affect your ability to walk?
3. To what degree does stiffness in your knee affect your _5_ My knee does not affect my ability to walk.
daily activity level? _4_ I have pain in my knee when walking, but it does
_5_ I never have stiffness in my knee. not affect my ability to walk.
_4_ I have stiffness in my knee, but it does not affect my _3_ My knee prevents me from walking more than 1 mile.
daily activity. _2_ My knee prevents me from walking more than
_3_ Stiffness affects my activity slightly. 1/2 mile.
_2_ Stiffness affects my activity moderately. _1_ My knee prevents me from walking more than 1
_1_ Stiffness affects my activity severely. block.
_0_ Stiffness in my knee prevents me from performing _0_ My knee prevents me from walking.
all daily activities. 9. Because of your knee, do you walk with crutches or a
4. To what degree does swelling in your knee affect your cane?
daily activity level? _3_ I can walk without crutches or a cane.
_5_ I never have swelling in my knee. _2_ My knee causes me to walk with 1 crutch or a cane.
_4_ I have swelling in my knee, but it does not affect my _1_ My knee causes me to walk with 2 crutches.
daily activity. _0_ Because of my knee, I cannot walk even with
_3_ Swelling affects my activity slightly. crutches.
_2_ Swelling affects my activity moderately. 10. Does your knee cause you to limp when you walk?
_1_ Swelling affects my activity severely. _2_ I can walk without a limp.
_0_ Swelling in my knee prevents me from performing _1_ Sometimes my knee causes me to walk with a limp.
all daily activities. _0_ Because of my knee, I cannot walk without a limp.
5. To what degree does slipping of your knee affect your 11. How does your knee affect your ability to go up stairs?
daily activity level? _5_ My knee does not affect my ability to go up stairs.
_5_ I never have slipping of my knee. _4_ I have pain in my knee when going up stairs, but it
_4_ I have slipping of my knee, but it does not affect my does not limit my ability to go up stairs.
daily activity. _3_ I am able to go up stairs normally, but I need to rely
_3_ Slipping affects my activity slightly. on use of a railing.
_2_ Slipping affects my activity moderately. _2_ I am able to go up stairs one step at a time with
_1_ Slipping affects my activity severely. use of a railing.
_0_ Slipping of my knee prevents me from performing _1_ I have to use crutches or a cane to go up stairs.
all daily activities. _0_ I cannot go up stairs.
Figure 21-A.6 Knee Outcome Survey: Activities of Daily Living Scale. Reprinted from Irrgang et al. (1998).
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Appendix 319
12. How does your knee affect your ability to go down 15. How does your knee affect your ability to squat?
stairs? _5_ My knee does not affect my ability to squat. I can
_5_ My knee does not affect my ability to go down squat all the way down.
stairs. _4_ I have pain when squatting, but I can still squat all
_4_ I have pain in my knee when going down stairs, the way down.
but it does not limit my ability to go down stairs. _3_ I cannot squat more than 3/4 of the way down.
_3_ I am able to go down stairs normally, but I need _2_ I cannot squat more than 1/2 of the way down.
to rely on use of a railing. _1_ I cannot squat more than 1/4 of the way down.
_2_ I am able to go down stairs one step at a time _0_ I cannot squat at all.
with use of a railing.
_1_ I have to use crutches or a cane to go down 16. How does your knee affect your ability to sit with your
stairs. knee bent?
_0_ I cannot go down stairs. _5_ My knee does not affect my ability to sit with
my knee bent. I can sit for unlimited amounts
13. How does your knee affect your ability to stand? of time.
_5_ My knee does not affect my ability to stand. I can _4_ I have pain when sitting with my knee bent, but it
stand for unlimited amounts of time. does not limit my ability to sit.
_4_ I have pain in my knee when standing, but it does _3_ I cannot sit with my knee bent for more than 1
not limit my ability to stand. hour.
_3_ Because of my knee I cannot stand for more than _2_ I cannot sit with my knee bent for more than
1 hour. 1
2 hour.
_2_ Because of my knee I cannot stand for more than _1_ I cannot sit with my knee bent for more than
1
2 hour. 10 minutes.
_1_ Because of my knee I cannot stand for more than _0_ I cannot sit with my knee bent.
10 minutes.
_0_ I cannot stand because of my knee. 17. How does your knee affect your ability to rise from a
chair?
14. How does your knee affect your ability to kneel on the _5_ My knee does not affect my ability to rise from a chair.
front of your knee? _4_ I have pain when rising from the seated position,
_5_ My knee does not affect my ability to kneel on the but it does not affect my ability to rise from the
front of my knee. I can kneel for unlimited amounts seated position.
of time. _2_ Because of my knee I can only rise from a chair if
_4_ I have pain when kneeling on the front of my knee, I use my hands and arms to assist.
but it does not limit my ability to kneel. _0_ Because of my knee I cannot rise from a chair.
_3_ I cannot kneel on the front of my knee for more
than 1 hour.
_2_ I cannot kneel on the front of my knee for more
than 12 hour.
_1_ I cannot kneel on the front of my knee for more
than 10 minutes.
_0_ I cannot kneel on the front of my knee.
Figure 21-A.6 Knee Outcome Survey: Activities of Daily Living Scale. (From Irrgang et al. 1998). continued
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Figure 21-A.7 The 12-Item Oxford Knee Questionnaire. Reprinted from Dawson et al. (1998).
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Appendix 321
Figure 21-A.8 The Marshall Scoring System. Reprinted from Marshall et al. (1977).
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Figure 21-A.9 The Revised Hospital for Special Surgery Knee Ligament Rating Form. Reprinted from Windsor et al. (1988).
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TOTAL SCORE
SCORE CHART
Excellent 95100 Fair 6583
Good 8494 Poor 64
Figure 21-A.10 The Lysholm Knee Scoring Scale. Reprinted from Tegner and Lysholm (1985).
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Figure 21-A.11 The Tegner Activity Score. Reprinted from Tegner and Lysholm (1985).
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Appendix 325
by patient Date:
PLEASE PRINT
IDENTIFICATION
Name SS # OFF #
(LAST) (FIRST) (INITIAL)
Jumping
If your normal knee performs 100%, at what %
Stairs does your operated knee perform?
Figure 21-A.12 The Feagin and Blake Scoring System. The ACL Follow-Up Form. Reprinted from Feagin and Blake (1983).
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SIDE 2
To be filled out by physician
(make sure side 1 is complete)
Type ACL Injury: Acute (1 wk) Sub Acute (16 wks) Chronic (6 wks) Acute on Chronic
Associated Injury (acute or chronic): MCL PCL LCL Med Men Lat Men
SURGICAL Hx
90
Sublux (Pivot Shift. Jerk. etc.) 140
STABILITY
45
90
record as 0 tr 1 2 3 10
Varus Valgus Varus 0 L
30 140
45
90
1) The Symptom score is the total score/4 of the entire symptom section
CAPSULE
2) The Function score is the score of the activity level question only
3) The Stability score comes from only the Ant Draw/Lach/Sublux portion of the
P.E. as follows: 5 none of the 3 tests trace; 4 none of the 3 tests >1; 3 two
tests 1 one test 2; 2 two tests 2 one test 1; 1 all tests 2.
The Capsule Summary is intended to give a brief picture
of the patient NOT summarise all of the above data.
Figure 21-A.12 The Feagin and Blake Scoring System. The ACL Follow-Up Form. Reprinted from Feagin and Blake (1983). continued
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Appendix 327
CATEGORIES DATE:
A pain/swelling B ROM/strength
preop.
C stability D function
examiner:
POINTS:
(category) Total
CRITERION: NUMBER OF POINTS: A B C D
HISTORY
pain (5 no; 3 rare; 2 frequ.; 0 severe)
swelling (5 no; 3 = rare; 2 = frequ.; 0 = always)
giving way (true) (5 no; 2 rare; 0 frequ.)
work (5 full; 3 part.; 1 change; 0 unable)
sports (5 = unlim.; 3 = limit.; 1 = maj.limit.; 0 = unable)
GENERAL FINDINGS AT EXAMINATION
effusion/swelling (5 no; 3 minim.; 1 moder.; 0 severe)
tenderness (5 no; 3 minim.; 1 moder.; 0 severe)
diff.circumference thigh (5 no; 3 2cm; 1 2cm)
extension-deficit(pass.) (5 no; 3 5degr.; 1 10degr.; 0 10degr.)
flexion (passive) (5 free; 3 120degr.; 1 90degr.; 0 90degr.)
INSTABILITY
anterior (5 no; 4 ; 2 ; 0 )
posterior (5 no; 4 ; 2 ; 0 )
Lachman (5 no; 4 ; 2 ; 0 )
lateral (in 30 degr.Flex) (5 no; 4 ; 2 ; 0 )
medial (in 30 degr.Flex) (5 no; 4 ; 2 ; 0 )
pivot shift (5 no; 3 uncertain; 0 pos.)
reversed pivot shift (5 neg.; 0 pos.)
FUNCTIONAL TESTS
lateral jump on one leg (5 free; 3 difficult; 1 not possible)
kneeflexion on one leg (5 free; 3 difficult; 1 not possible)
duck-walking (5 free; 3 difficult; 1 not possible)
EVALUATION
EXCELLENT (CATEGORIES: 04 missing pts., no parameter 0 pts. 0 0 0 0
TOTAL: 90 pts. and excellent in all categories) 0
GOOD (CATEGORIES: 59 missing pts., no parameter 0 pts. 0 0 0 0
TOTAL: 8190 pts. or good in any single category) 0
FAIR (CATEGORIES: 1014 missing pts. or any parameter 0 pts. 0 0 0 0
TOTAL: 7180 pts. or fair in any single category) 0
POOR (CATEGORIES: 14 missing pts. 0 0 0 0
TOTAL: 70 pts. or poor in any single category) 0
Figure 21-A.13 Evaluation form of the Swiss Knee Group (OAK). Reprinted from Muller et al. (1988).
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Figure 21-A.14 The 1993 International Knee Documentation Committee (IKDC) Knee Ligament Standard Evaluation Form. Reprinted
from Hefti et al. (1993).
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DIRECTIONS: Using the key below, circle the appropriate boxes on the four scales below which indicate the highest level
you can reach WITHOUT having symptoms.
Scale Description
10 Normal knee, able to do strenuous work /sports with jumping, hard pivoting
8 Able to do moderate work /sports with running, turning and twisting; symptoms with strenuous work /sports
6 Able to do light work /sports with no running, twisting or jumping; symptoms with moderate work /sports
4 Able to do activities of daily living alone; symptoms with light work /sports
2 Moderate symptoms (frequent, limiting) with activities of daily living
0 Severe symptoms (constant, not relieved) with activities of daily living
1. PAIN
10 8 6 4 2 0
4. FULL GIVING-WAY (knee collapse occurs with actual falling to the ground)
10 8 6 4 2 0
Patient Grade: Rate the overall condition of your knee at the present time. Circle one number below.
1 2 3 4 5 6 7 8 9 10
poor fair good normal
Sports Activity Scale, Activities of Daily Living Function Scales, Sports Function Scales
Figure 21-A.15 The Cincinnati Knee Rating System. (I) Symptom Rating Scales and Patient Perception Scale; (II) Sports Activity Scale,
Activities of Daily Living Function Scales, and Sports Function Scales; (III) Occupational Rating Scale; (IV) Overall Rating Scheme; (V)
Modifications for Overall Rating Scheme: Symptom and Instability Ratings. Reprinted from Barber-Westin et al. (1999).
04098-21.qxd 07/02/2004 17:56 PM Page 330
0 8 10 0 0 0 0 0 0 0 0 0 0 0 0 5 lbs
hrs/day hr/day hr/day times/day times/day times/day
1 6 7 2 1 2 1 1 15 2 1 flight, 1 15 1 6 10 lbs
hrs/day hr/day hr/day times/day 2 times/day times/day
4 1 8 6 7 8 6 7 4 16 20 8 ladders 4 16 20 4 26 30 lbs
hr/day hrs/day hrs/day times/day with weight times/day
2 3 days/
week
Figure 21-A.15 The Cincinnati Knee Rating System. (I) Symptom Rating Scales and Patient Perception Scale; (II) Sports Activity Scale,
Activities of Daily Living Function Scales, and Sports Function Scales; (III) Occupational Rating Scale; (IV) Overall Rating Scheme; (V)
Modifications for Overall Rating Scheme: Symptom and Instability Ratings. Reprinted from Barber-Westin et al. (1999). continued
04098-21.qxd
Overall Rating Scheme
07/02/2004
10 Normal knee, able to do strenuous work /sports with jumping, hard pivoting
8 Able to do moderate work /sports with running, twisting, turning; symptoms with strenuous work /sports Level Pts. Level Pts. Level Pts. Level Pts.
6 Able to do light work /sports with no running, twisting, jumping; symptoms with moderate work /sports Pain 10 8 6 4 2 0 10 5 8 3 64 1 20 0
4 Able to do activities of daily living alone; symptoms with light work /sports
2 Moderate symptoms (frequent, limiting) with ADL
Swelling 10 8 6 4 2 0 10 5 8 3 64 1 20 0
0 Severe symptoms (constant, not relieved) with ADL Partial Giving-Way 10 8 6 4 2 0 10 5 8 3 64 1 20 0
*highest level possible with no or rare symptoms Full Giving-Way 10 8 6 4 2 0 10 5 8 3 64 1 20 0
17:56 PM
Activity Level: 15 points
Pts 3 Pts 2 Pts 1 Pts 0 Pts. Pts. Pts. Pts.
Walking Normal, unlimited Some limitations Only 3 4 blocks possible Less than 1 block, cane 3 2 1 0
Stairs Normal, unlimited Some limitations Only 1130 steps possible Only 110 steps possible Score 3 2 1 0
Squatting Normal, unlimited Some limitations Only 6 10 possible Only 0 5 possible lowest
Running Normal, unlimited Some limitations Run 1/2 speed Not able to do 3 2 1 0
Page 331
Jumping Normal, unlimited Some limitations Definite limitations, 1/2 speed Not able to do 3 2 1 0
Twists/Cuts Normal, unlimited Some limitations Definite limitations, 1/2 speed Not able to do 3 2 1 0
Examination: 25 points
NL Pts MILD Pts MOD Pts SEV Pts Pts. Pts. Pts. Pts.
Effusion NL 5
25 cc 4 26 60 cc 2 60 cc 0 5 4 2 0
Lack of Flexion 0 5 5 6 15 4 16 30 2 30 0 5 4 2 0
Lack of Extension 0 3 5 4 5 4 6 10 2 10 0 5 4 2 0
Tibiofemoral Crepitus NL 5 Mod* 2 Sev* 0 5 2 0
Patellofemoral Crepitus NL 5 Mod* 2 Sev* 0 5 2 0
(*indicates definite fibrillation, cartilage abnormality; moderate 25 50, severe 50)
Instability: 20 points
Pts Pts Pts Pts
Anterior (KT-1000) 3 mm 10 3 5 mm 7 6 mm 4 6 mm 0 10 7 4 0
Pivot Shift negative 10 slip 7 definite 4 severe 0 10 7 4 0
Appendix
One-Legged Hop, cross-over for distance ___% limb symmetry
Final Rating Acute Injury Studies: Category______ Final Rating Chronic Injury Studies: Point Sum______
Excellent: all in excellent (may have one in good); Good: all in excellent and good
Fair: any one in fair; Poor: any one in poor
331
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332
Modifications for Overall Rating Scheme: Symptom and Instability Ratings
07/02/2004
Level Pts. Level Pts. Level Pts. Level Pts.
6 Able to do light /moderate/strenuous work /sports without symptoms Pain 6 4 2 0 6 5 4 3 2 1 0 0
The Knee
4 Able to do activities of daily living alone; symptoms with light /moderate strenuous work /sports
2 Moderate symptoms (frequent, limiting) with ADL
Swelling 6 4 2 0 6 5 4 3 2 1 0 0
0 Severe symptoms (constant, not relieved) with ADL Partial Giving-Way 6 4 2 0 6 5 4 3 2 1 0 0
Full Giving-Way 6 4 2 0 6 5 4 3 2 1 0 0
Instability*: 20 points
17:56 PM
Pts. Pts. Pts. Pts. Pts. Pts.
ACL 3 mm 5 3 5.5 mm 3 6 mm 0 5 3 0
PCL 3 mm 5 3 5.5 mm 3 6 mm 0 5 3 0
MCL 3 mm 5 3 5 mm 3 6 mm 0 5 3 0
LCL /PL complex 3 mm & 5 ER 5 3 5 mm or 6 10 ER 3 5 mm or 10 ER 0 5 3 0
Page 332
*ACL: use knee arthrometer test total AP displacement 20, 134 N, involved-noninvolved limb
PCL: use knee arthrometer test (70, 89 N) or stress radiographs (70, 89 N)
MCL: use valgus stress test, 25
LCL /PL complex: use varus stress test 25, external tibial rotation test 30 & 90, varus recurvatum test
Figure 21-A.15 The Cincinnati Knee Rating System. (I) Symptom Rating Scales and Patient Perception Scale; (II) Sports Activity Scale, Activities of Daily Living Function Scales,
and Sports Function Scales; (III) Occupational Rating Scale; (IV) Overall Rating Scheme; (V) Modifications for Overall Rating Scheme: Symptom and Instability Ratings. Reprinted
from Barber-Westin et al. (1999). continued
04098-21.qxd
KNEE DISORDERS SUBJECTIVE HISTORY 15. Do you have problems going down stairs?
none unable not attempted
NAME
16. Do you have problems running?
07/02/2004
CHART DATE SIDE: L R none unable not attempted
1. How often does your knee hurt? 18. Do you have problems cutting
never daily even at rest (changing directions while running by pivoting
17:56 PM
on affected knee)?
2. How bad is the pain at its worst? none unable not attempted
none severe, requiring pain pills
every few hours 19. Do you have problems jumping?
3. Do you have swelling in your knee? none unable not attempted
never daily, even at rest
20. Do you have problems taking part in
4. Does your knee give way or buckle? I must gaurd my knee to prevent competitive sports?
Page 333
never giving way even with normal everyday none unable not attempted
activity
21. Do you have night pain?
5. Does your knee lock up so you are unable I must gaurd my knee to prevent
none severe
to straighten it? locking even with normal everyday
never activity 22. Do you have problems kneeling?
no problem unable not attempted
6. Does your knee catch or hang up when I must gaurd my knee to prevent
moving? catching even with normal everyday 23. Do you have problems squatting?
never activity no problem unable not attempted
7. Is your knee stiff? I can barely move my knee 24. Do you have problems getting in
none because of stiffness and out of a car?
no problem unable
8. Are you able to walk on level groud?
no problem unable 25. Does your knee ache while you are sitting?
never always
9. Are you able to walk on rough ground,
26. Do you have problems getting in
inclines, or negotiate curves?
or out of a chair?
no problem unable
no problem unable
10. Do you need crutches, cane, or walker to walk? 27. Do you have stiffness or discomfort
never always when you first start to walk?
11. Do you feel grinding when your knee moves? none always
none severe 28. Do you have problems turning over in bed?
12. Do you have problems twisting or pivoting none unable
on your injured knee?
none unable
13. Do you have problems carrying heavy
objects because of your knee?
none unable not attempted
14. Do you have problems climbing stairs?
none unable not attempted
Appendix
HUGHSTON SPORTS MEDICINE FOUNDATION, INC. HUGHSTON SPORTS MEDICINE FOUNDATION, INC.
Figure 21-A.16 Visual analogue scales for assessing subjective knee complaints. Reprinted from Flandry et al. (1991).
333
04098-21.qxd 07/02/2004 17:56 PM Page 334
Symptoms and Physical Complaints 7. How much of a concern is it for you to miss days from
1. With respect to your overall knee function. How troubled work due to problems or reinjury to your knee? (Make a
are you by giving way episodes? (Make a slash at the slash at the extreme left, i.e., 0, if you are unable to
extreme right, i.e., 100, if you are experiencing no giving work because of the knee.)
way episodes in your knee. Please note that this ques- 0 __________________________________ 100
tion has two parts. It is concerned with both the severity An extremely No concern
(1a) and frequency (1b) of the giving way episodes.) significant concern at all
1a 0 ____________________________________ 100 8. How much of a concern is it for you to lose time from
Major giving way Minor giving way school or work because of the treatment of your ACL-
episodes episodes deficient knee?
1b 0 ____________________________________ 100 0 __________________________________ 100
Constantly Never An extremely No concern
giving way giving way significant concern at all
Recreational Activities and Sport Participation or
2. With any kind of prolonged activity (i.e., greater than Competition
half an hour) how much pain or discomfort do you get
in your knee? The following questions are concerned with your ability
to function and participate in these activities as they relate
0 ____________________________________ 100 to your ACL-deficient knee. Consider the last three
Severe No pain months.
pain at all
9. How much limitation do you have with sudden twisting
3. With respect to your overall knee function, how much and pivoting movements or changes in direction?
are you troubled by stiffness or loss of motion in your
knee? 0 __________________________________ 100
Totally No
0 ____________________________________ 100 limited limitations
Severely Not troubled 10. How much of a concern is it for you that your sporting
troubled at all or recreational activities may result in the status of your
4. Consider the overall function of your knee and how it knee worsening?
relates to the strength of your muscles: How weak is 0 __________________________________ 100
your knee? An extremely No concern
0 ____________________________________ 100 significant concern at all
Extremely Not weak 11. How does your current level of athletic or recreational
weak at all performance compare with your preinjury level?
Work-Related Concerns 0 __________________________________ 100
Totally No
The following questions are being asked with respect to your limited limitations
job or vocation. The questions are concerned with your abil-
12. With respect to the activities or sports that you currently
ity to function at work and how your knee has affected your
desire to be involved with, how much have your expec-
current work situation, i.e., your work-related concerns. If you
tations changed because of the status of your knee?
are a full-time student or home maker consider this and any
part-time work together. Consider the last three months. 0 __________________________________ 100
If you are currently not employed for reasons other than Expectations totally Expectations
your knee then place a check on this line._______________ lowered not lowered at all
5. How much trouble do you have, because of your
knee, with turning or pivoting motions at work? (Make 13. Do you have to play your recreation or sport under cau-
a slash at the extreme left, i.e., 0, if you are unable to tion? (Make a slash at the extreme left, i.e., 0, if you are
work because of the knee.) unable to play your recreation or sport because of your
knee.)
0 ____________________________________ 100 0 __________________________________ 100
Severely No trouble Always play Never play
troubled at all under caution under caution
6. How much trouble do you have, because of your 14. How fearful are you of your knee giving way when play-
knee, with squatting motions at work? (Make a slash ing recreation or sport? (Make a slash at the extreme
at the extreme left, i.e., 0, if you are unable to work left, i.e., 0, if you are unable to play recreation or sport
because of the knee.) because of your knee.)
0 ____________________________________ 100 0 __________________________________ 100
Severely No trouble Extremely No fear
troubled at all fearful at all
Figure 21-A.17 Quality of Life Assessment in anterior cruciate ligament (ACL) deficiency. Note: on the actual form, the lines are 100 mm
long. Reprinted from Mohtadi (1998).
04098-21.qxd 07/02/2004 17:56 PM Page 335
Appendix 335
15. Are you concerned about environmental conditions such 22. How much has your ability to exercise and maintain fit-
as a wet playing field, a hard court, or the type of gym ness been limited by your knee problem?
floor when involved in your recreation or sport? (Make a 0 __________________________________ 100
slash at the extreme left, i.e., 0, if you are unable to play Totally Not limited
recreation or sport because of your knee.) limited at all
0 __________________________________ 100 23. How much has your enjoyment of life been limited by
Extremely Not concerned your knee problem?
concerned at all
0 __________________________________ 100
16. Do you find it frustrating to have to consider your knee Totally limited Not limited at all
with respect to your recreation or sport?
24. How often are you aware of your knee problem?
0 __________________________________ 100
Extremely Not frustrated 0 __________________________________ 100
frustrated at all All of None of
the time the time
17. How difficult is it for you to go full out at your recreation or
sport? (Make a slash at the extreme left, i.e., 0, if you are 25. Are you concerned about your knee with respect to life
unable to play recreation or sport because of your knee.) style activities that you and your family do together?
0 __________________________________ 100 0 __________________________________ 100
Extremely Not difficult Extremely No concern
difficult at all concerned at all
18. Are you fearful of playing contact sports? (Circle the N/A 26. Have you modified your life style to avoid potentially
at the right of the scale if you do not play contact sport for damaging activities to your knee?
reasons other than the knee.) 0 __________________________________ 100
0 __________________________________ 100 N/A Totally No
Extremely No fear modified modifications
fearful at all Social and Emotional
The following questions are specifically asking about the two The following questions are about your attitudes and feelings
most important sports or recreational activities that you do or as they relate to your ACL-deficient knee.
that you wish to do. Please write them in order. 27. Does it concern you that your competitive needs are no
1. ________________________________________ longer being met because of your knee problem?
2. ________________________________________ (Make a slash at the extreme right, i.e., 100, if your
19. How limited are you in playing the number 1 sport or competitive needs are being met.)
activity? (Make a slash at the extreme left, i.e., 0, if you 0 __________________________________ 100
are unable to play the recreation or sport because of your Extremely Not concerned
knee.) concerned at all
0 __________________________________ 100 28. Have you had difficulty being able to psychologically
Extremely Not limited come to grips with your knee problem?
limited at all
0 __________________________________ 100
20. How limited are you in playing the number 2 sport or Extremely Not difficult
activity? (Make a slash at the extreme left, i.e., 0, if you difficult at all
are unable to play the recreation or sport because of your
knee.) 29. How often are you apprehensive about your knee?
0 __________________________________ 100 0 __________________________________ 100
Extremely Not limited All of None of
limited at all the time the time
Life Style 30. How much are you troubled with lack of confidence in
your knee?
The following questions are concerned with your life style in
general and should be considered outside of your work and 0 __________________________________ 100
recreational or sport activities as they relate to your ACL- Severely No trouble
deficient knee. troubled at all
21. Do you have to concern yourself with general safety 31. How fearful are you of reinjuring your knee?
issues (e.g., carrying small children, working in the yard) 0 __________________________________ 100
with respect to your ACL-deficient knee? Extremely No fear
0 __________________________________ 100 fearful at all
Extremely No concern
concerned at all
Figure 21-A.17 Quality of Life Assessment in anterior cruciate ligament (ACL) deficiency. Note: on the actual form, the lines are
100 mm long. Reprinted from Mohtadi (1998). continued
04098-21.qxd 07/02/2004 17:56 PM Page 336
Knee instability scale modified for evaluation of patellofemoral pain and instability
Pain /instability No. of available points
Limp
None 10
Slight 5
Severe 0
Support
Full 10
Cane or crutch necessary at times 3
Weightbearing impossible 0
Stair climbing
No problem 10
Slightly impaired 6
One step at a time 2
Unable 0
Squatting
No problem 5
Slightly impaired 4
Not past 90 of knee flexion 2
Unable 0
Instability
Never gives way 10
With vigorous activity 5
Occasionally in daily activities 5
Often in daily activities 3
Every day 0
Pain
None 45
Slight during vigorous exercise only 40
Moderate with vigorous exercise 35
Severe after vigorous exercise 25
Severe after walking 1 mile 20
Severe after walking less than 12 mile 10
Constant and severe 2
Swelling
None 10
With giving way 7
On severe exertion 5
On mild exertion 2
Constant 0
Figure 21-A.18 The Fulkerson modification of the Lysholm score for assessing the outcome
of anterior knee pain. Reprinted from Fulkerson et al. (1990).
04098-21.qxd 07/02/2004 17:56 PM Page 337
Appendix 337
Figure 21-A.19 The Kujala scoring system for anterior knee pain, and its evaluation form. Reprinted from Kujala et al. (1993).
04098-21.qxd 07/02/2004 17:56 PM Page 338
Figure 21-A.20 Grading system related to meniscal disorders. Reprinted from Tapper and Hoover (1969).
Acceptable Unacceptable
Figure 21-A.21 Evaluation of treatment for tibial condylar fractures: the Rasmussen criteria. Reprinted from Rasmussen (1973).
04098-22.qxd 06/02/2004 14:39 PM Page 339
22
The ankle and hindfoot
Mark L. Herron and Michael M. Stephens
RADIOGRAPHIC OUTCOME
ACHILLES TENDON DISORDERS
The role of radiographs in the measurement of out-
come may be categorized into the assessment of extra- This is an area where debate continues between oper-
articular alignment and joint congruency, and the ative or conservative treatment for acute rupture.
assessment of union and detection of osteoarthritis. Evidence either way is certainly hampered by the
The information yielded by radiographs cannot be lack of agreed outcome measures (Maffulli 1999).
04098-22.qxd 06/02/2004 14:39 PM Page 341
Table 22.1: Achilles tendon repair score. Reprinted from Leppilahti et al. (1998)
Pain
None 15
Mild, no limited recreational activities 10
Moderate, limited recreational, but not daily activities 5
Severe, limited recreational and daily activities 0
Stiffness
None 15
Mild, occasional, no limited recreational activities 10
Moderate, limited recreational but not daily activities 5
Severe, limited recreational and daily activities 0
04098-22.qxd 06/02/2004 14:39 PM Page 342
Table 22.1: Achilles tendon repair score. Reprinted from Leppilahti et al. (1998) continued
Table 22.2: The VISA-A Questionnaire. Reprinted from Robinson et al. (2001):The VISA-A questionnaire, Br J Sports Med, 35, 33541,
with permission from the BMJ Publishing Group
1. For how many minutes do you have stiffness in the Achilles region on first getting up?
POINTS
100 min 0 1 2 3 4 5 6 7 8 9 10 0 min
2. Once you are warmed up for the day, do you have pain when stretching the Achilles tendon fully over the edge of a
step? (keeping knee straight)
Strong
Severe POINTS
Pain 0 1 2 3 4 5 6 7 8 9 10 No pain
04098-22.qxd 06/02/2004 14:39 PM Page 343
3. After walking on flat ground for 30 minutes, do you have pain within the next 2 hours? (if unable to walk on flat
ground for 30 minutes because of pain, score 0 for this question).
Strong
Severe POINTS
0 1 2 3 4 5 6 7 8 9 10 No pain
Pain
Strong
Severe POINTS
0 1 2 3 4 5 6 7 8 9 10 No pain
Pain
5. Do you have pain during or immediately after doing 10 (single leg) heel raises from a flat surface?
Strong
Severe POINTS
0 1 2 3 4 5 6 7 8 9 10 No pain
Pain
POINTS
0 0 1 2 3 4 5 6 7 8 9 10 10
0 Not at all
4 Modified training modified competition
7 Full training but not at same level as when symptoms began POINTS
10 Competing at the same or higher level as when symptoms began
0 7 14 21 30
OR
B. If you have some pain while undertaking Achilles tendon loading sports, but it does not stop you from completing
your training/practice, for how long can you train/practise?
NIL 110 min 1120 min 2130 min 30 min POINTS
0 7 14 21 30
04098-22.qxd 06/02/2004 14:39 PM Page 344
OR
C. If you have pain that stops you from completing your training/practice in Achilles tendon loading sports, for how
long can you train/practise?
NIL 110 min 1120 min 2130 min 30 min POINTS
0 7 14 21 30
TOTAL SCORE (100)%
LATERAL LIGAMENT COMPLEX gold standard with which to compare the scores.
No longitudinal data were supplied, and so it is not
The only score for which any attempt has been made possible to comment upon the sensitivity to change
to demonstrate validity and reliability is that of of the score. Other scores worthy of mention are
Kaikkonen et al. (1994) (Table 22.3). This is worthy those of Karlsson and Peterson (1991) (Table 22.4)
of description flawed though its methodology is in and St. Pierre et al. (1982) and Good et al. (1975).
parts. A maximum 100 points are awarded 40 for Of these scores, that of Karlsson and Peterson has
subjective symptoms and assessment of function, probably been the most widely used. A purely sub-
and 60 points for four objective tests of function jective score 45 of the 100 points are given to insta-
(one for balance, one for functional stability, two for bility and pain. Results with this score have
muscle strength), assessment of antero-posterior corresponded well with a simplified version by
(AP) laxity and range of movement. The objective Nimon et al. (2001) which just comprised four cate-
tests were selected from a larger group following gories of pain and four of subjective instability. It is
side-to-side comparison testing. The reproducibility interesting to note from this study that whilst only
of the objective measures has been tested and 65 per cent of patients experienced no pain or insta-
appears high, but may be artificially so as figures bility, this correlated with an 86 per cent satisfaction
quoted are Pearsons correlation coefficients rather rate and with 97.7 per cent of patients willing to opt
than intra-class correlation coefficients. In addition, for the operation again given the same circum-
the discriminatory ability between 100 normal and stances. The difficulty with the heterogeneity of
148 operatively treated lateral ligament injuries for scoring systems used in this area is emphasized in a
each of the test fields was demonstrated. The validity meta-analysis by Pijnenburg et al. (2000). In exam-
of the score was assessed by correlating the total ining data from randomized controlled trials
scores achieved with isokinetic strength measure- between 1966 and 1998 for the treatment of lateral
ments and subjective functional assessment. The for- ligament injury, these authors were only able to
mer produced a low correlation, whereas the latter extrapolate and analyse three common measures of
correlated strongly with the score. Issue could be outcome for analysis, which were simply the time off
taken for using this functional assessment as the work, residual pain and giving way.
04098-22.qxd 06/02/2004 14:39 PM Page 345
Pain 40 50 40 50
Function
Limitations 10
Walk distance 5 6 20
Walk surface 5
Gait 8 6 4
Hills 6
Stairs 6 8 6
Support 6 6
Running 5
Single leg stand 4 6
Sitting 4
Heel rise 5 3
Heel walk 3
Footwear 6
Ankle movement 8 10 20 10
Hindfoot movement 6 6
Alignment 10 4
Stability 8
TOTAL POINTS 100 100 100 100
1 2 3 4
Poor Fair Good Excellent
changes) is well recognized. It may arise in an other- or ossification defects (Hepple et al. 1999). The
wise radiographically normal ankle or with vary- investigator is not spoilt for choice of outcome
ing degrees of degenerative change. Arthroscopic measures in this field. The phenomenon of talar
dbridement with osteophyte removal has become dome osteochondral lesions was first tackled sub-
the mainstay of surgical treatment in the salvage- stantively during the late 1950s (Berndt and Harty,
able joint. 1959). Both the clinical outcome grading as well as
One of the most commonly used scoring systems is the radiographic classification, based on the degree
that of Ogilvie-Harris (Ogilvie-Harris et al. 1993) of displacement, described by the original authors
(Table 22.6), which is purely subjective and allows saw wide (though not unqualified) acceptance. In
one of four responses to each of the criteria of pain, particular, the value of their preoperative radio-
swelling, stiffness, limping, and activity. Both the graphic classification is being increasingly questioned
original author as well as subsequent ones (Tol et al. in the light of magnetic resonance imaging (MRI)
2001) have noted a lack of correlation between (Hepple et al. 1999) and arthroscopic (Kumai et al.
patient satisfaction (excellent or good in 53%) and 1999; Tol et al. 2000) findings. Likewise, their out-
the scores yielded (similar gradings in only 29%). come score continues to be used (Pritisch et al.
In context, this was only in ankles with associated 1986; Kumai et al. 1999), and has in its favour that
established arthritic changes. Those with none or it is simple and subjective but potentially has low
early changes however showed a high level of discriminatory power given the presence of only
agreement between the score and patient satisfac- three categories. A good result corresponds to
tion judged with the same four categories (Tol occasional symptoms but no disabling pain; a fair
et al. 2001). result to a decrease in symptoms but still some dis-
abling pain; and a poor result to no decrease in symp-
toms. Other scores with a mixture of subjective and
OSTEOCHONDRAL LESIONS OF objective criteria and a greater detail have also been
THE TALAR DOME used. Examples are: (i) the Hannover score (Hangody
et al. 1997; Gautier et al. 2002) (Table 22.7), which
The aetiology of these lesions is frequently, though encompasses 68 points for subjective and 36 for
not exclusively, post-traumatic. There are a propor- objective outcomes; and (ii) the AOFAS (Kitaoka
tion of cases with no history of trauma (Campbell et al. 1994). These have been shown to correlate well
and Ranawat 1966), and various hypotheses have statistically with each other, but are no more valid-
been suggested including spontaneous osteonecrosis ated than the score of Berndt and Harty (1959).
04098-22.qxd 06/02/2004 14:39 PM Page 349
Subjective
Pain None On exertion Moderate Constant 12/9/6/3
Swelling None With sports With daily exertion Constant 8/6/4/2
Deficit in ROM None Moderate Considerable Stiff 8/6/4/2
Postop. improvement Normal function Considerable Moderate None/worse 8/6/4/2
Limping None After strenuous Intermittent Constant 4/3/2/1
exercise
Locking None Causing no Causing intermittent Considerable 8/6/4/2
limitations limitations limitations
Giving way None With exercise Intermittent, Regularly 8/6/4/2
uneven ground
Objective
Function Normal 10 deficit pf/df 1115 deficit pf/df 15 deficit 16/12/8/4
pf/df
Instability None 1 12 2 4/3/2/1
Arthritis No signs 1 2 3 8/6/4/2
Perception None Temporary, 2 Month, 2 Month 8/6/4/2
disorders persistent
Calcaneal fractures
Tibiocalcaneal and pantalar fusions self-evidently The question of whether or not to fix displaced
will result in the loss of all true hindfoot movement. intra-articular calcaneal fractures still excites
In addition, a successful result is likely to result in debate. There is general acceptance that providing
significant functional impairment, and is often per- robust evidence for either side of the argument is
formed in patients with very poor function. Any hampered by the lack of an accepted, validated
scoring system with a fair proportion of weighting scoring system. The outcome scores commonly
given to range of movement and emphasis upon used fall into four categories:
function such as the AOFAS will be inappropriate
in these circumstances. A modified version lacking
the measurement of movement and with more
The AOFAS scores (Park et al. 2000);
appropriate functional parameters has been sug- The specialized calcaneal fracture scores
gested (Acosta et al. 2000) (Table 22.8). A simpler comprising a mixture of subjective and
and purely subjective score with appropriate levels objective criteria; examples include the
of functional attainment for tibiocalcaneal fusion Maryland foot score (Sanders et al. 1993),
also exists (Kitaoka and Patzer 1998). the Creighton-Nebraska score (Crosby and
04098-22.qxd 06/02/2004 14:39 PM Page 351
Fractures 351
Table 22.9: The scoring system of Olerud and Molander (1984). Table 22.10: Maryland foot score. Reprinted from Sanders et al.
Reproduced by permission of Springer-Verlag (1993)
References 353
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23
The foot
Roger M. Atkins
Measuring deformity
CLINICAL EXAMINATION Osteoarthritis
Qualitative observational assessment of clinical
deformity is simple, although quantification is all The development of osteoarthritis is a common
but impossible. Fixed deformity must be measured outcome measure particularly following trauma
with the foot unloaded in order to avoid compen- (Olerud and Molander 1984; Heim 1989), and
satory actions of unaffected joints (Oatis 1988). minimization of late degeneration is one argument
for the anatomic operative fixation of fractures
RADIOGRAPHIC EXAMINATION (Wright 1990), though exact reduction may not be
Routine projections include antero-posterior (AP), necessary (Bauer et al. 1985).
lateral, internal oblique and external oblique views. The relationship between arthritic symptoms and
Non-weight-bearing views are adequate for assessing severity of radiographic change is inconsistent
structural anatomy, including common normal vari- (Bagge et al. 1991; Hart et al. 1991), in part due to
ants. Weight-bearing studies are important for repro- the radiographic assessment methods. The Kellgren
ducible serial measurements, particularly where the and Lawrence scale (Kellgren and Lawrence 1957)
radiographic angle may be susceptible to changes in is the most widely used, but it places significant
axis and where the stress of weight bearing may alter weight on the presence of osteophytes (Kellgren
the measurement, such as in hallux valgus or in tib- et al. 1963; Mazur et al. 1979; Hattrup and Johnson
ialis posterior insufficiency. It is essential to employ 1988; Heim 1989; Merchant and Dietz 1989),
standardized techniques both for radiographic exam- which may be inappropriate (Croft 1990). It is also
ination and measurement (Schneider and Knahr insensitive to early or mild disease, and if compari-
1998). Radiographic appearances vary widely in the sons between studies are to be undertaken then stan-
normal, asymptomatic foot and some common dardized radiographs must be employed.
radiographic measurements have unacceptably nar- At the knee joint, scales based predominantly upon
row reference ranges or are inaccurate (Steel et al. loss of joint space are more reproducible than those
1980). For angular measurements in hallux valgus, based on osteophytes (Dacre et al. 1988; Cooper
scientific studies of reproducibility have been under- et al. 1990), but although this type of scale has been
taken and show good reproducibility for the hallux used (Olerud and Molander 1984; Ahl et al. 1989) it
valgus angle and the 12 metatarsal angle (Smith has not been formally evaluated for the foot. The
et al. 1984; Coughlin et al. 2002). However the inter- only joint in the foot where the width has been
observer reliability of the distal metatarsal articular analysed is the ankle (Jonsson et al. 1984). Reliability
angle is poor, as is the ability to discriminate joint data for radiographic scales of osteoarthritis are
congruency (Coughlin 2001). scant. Both Wright and Acheson (1970) and Kellgren
04098-23.qxd 06/02/2004 14:39 PM Page 360
and Lawrence (1957) reported relatively poor intra- Table 23.2: Grading of hallux rigidus. Reprinted from Hattrup
and Johnson (1988)
and inter-observer reliability but did not provide
data for the measurement of joint width alone.
Hattrup and Johnson (1988) presented a scale for Grade 1: Mild to moderate osteophyte formation but
the assessment of the severity of osteoarthritis of the good joint space preservation
first metatarsophalangeal joint in hallux rigidus, but Grade 2: Moderate osteophyte formation with joint
without scientific validation (Table 23.2). space narrowing and subchondral cyst formation
Grade 3: Marked osteophyte formation and loss of the
visible joint space, with or without subchondral cyst
formation
Gait analysis
Normal human gait consists of a series of complex measurement of energy expenditure during loco-
coordinated movements, which are measured sys- motion (Whittle 1991).
tematically and quantified by gait analysis. Gait
analysis can be visual, or it can be achieved by VISUALIZATION
monitoring force and pressure measurements at The visual inspection of gait is unsystematic, subject-
the footground interface, by measuring muscle ive and observer skill-dependent (Whittle 1991).
action potentials (electromyography), or by the Even skilled observers miss subtle abnormalities and
04098-23.qxd 06/02/2004 14:39 PM Page 361
more stringent assessment of function than do either In a comparative study (Hughes et al. 1987), the
subjective analysis or clinical examination. However, force plate was found to be the most precise method,
notwithstanding improved instrumentation and though spatial resolution and reliability were poor
measurement techniques, it has not gained wide- [Coefficient of variation (CV) 18.323.3%], and it
spread clinical use except in the management of was also the most expensive to operate. The Harris
cerebral palsy, and is more suitable for the evalu- mat, which is cheap and easy to use, could be quanti-
ation of movement in large joints than in the foot tated only with difficulty, though its reliability was
and ankle. similar to that of the pedobarograph (CV 12%). The
pedobarograph was less accurate but more reliable
(CV 10.9%), the resolution was markedly better, and
ELECTROMYOGRAPHY the print-out clearly showed pressure distribution.
Electromyography is primarily useful to determine Advances in computing and sensor technology have
the timing of muscle contraction during the gait allowed major developments in pedobarography.
cycle, but it may be difficult to obtain satisfactory Data are collected and analysed using a portable com-
recordings from a walking subject. It is useful in puter. Here, two modern systems will be described
planning tendon transfers in cerebral palsy (Perry as examples, namely the Musgrave Footprint pres-
and Hoffer 1977), but has little place in outcome sure plate (Preston Communications, Ltd., Dublin,
assessment in the foot. Ireland) and the GAITrite system (CIR Systems, Inc.,
East Darby Road, Havertown, PA, USA).
Recommendations 363
THE AMERICAN ORTHOPAEDIC Table 23.3: American Orthopaedic Foot and Ankle Society
Grading for the midfoot. Reprinted from Kitaoka et al. (1994)
FOOT AND ANKLE SOCIETY
(AOFAS) SCORING SYSTEMS Pain (40 points)
None 40
Kitaoka et al. (1994) (Tables 23.323.5) described
a series of instruments aimed specifically at disabil- Mild, occasional 30
ity in various parts of the foot and ankle. These are Moderate, daily 20
hybrid-scoring systems because they combine elem- Severe, almost always present 0
ents of functional outcome with clinical evalu- Function (45 points)
ation. Although it is tempting to employ scoring Activity limitations, support
systems which have been developed specifically for No limitations, no support 10
the foot, these systems have not been subjected to
No limitations of daily activities, limitation
rigorous statistical analysis (Kerr et al. 1996), and of recreational activities, no support 7
preliminary analysis suggests that they may not
Limited daily and recreational activities, cane 4
behave in a statistically reliable fashion (Guyton
Severe limitation of daily and recreational
2001). Hence, the scores may not be susceptible to
activities, walker, crutches, wheelchair 0
analysis, at least using parametric methods.
Retrospective use of these scoring systems is unreli- Footwear requirements
able (Toolan et al. 2001). The increasing use of Fashionable, conventional shoes, no insert
these systems is providing a spurious validity, but it required 5
is imperative that a full analysis be performed Comfort footwear, shoe insert 3
before they are accepted scientifically. Modified shoes or brace 0
Maximum walking distance in blocks
6 10
46 7
GENERAL CONSIDERATIONS 13 4
1 0
The following should always be reported where rele-
vant. Wound healing, chronic sepsis, fracture or Walking surfaces
osteotomy healing, non-union, revision surgeries, No difficulty on any surface 10
failures, recovery times, nerve or vessel damage Some difficulty on uneven terrain, stairs,
associated with the index procedure, and any other inclines, ladders 5
significant complication (Chen et al. 2001). Severe difficulty on uneven terrain, stairs,
inclines, ladders 0
Gait abnormality
None, slight 10
RECOMMENDATIONS Obvious 5
MTPJ motion (dorsiflexion plus plantarflexion) MTPJ motion (dorsiflexion plus plantarflexion)
Normal or mild restriction (75) 10 Normal or mild restriction (75) 10
Moderate restriction (3074) 5 Moderate restriction (3074) 5
Severe restriction (30) 0 Severe restriction (30) 0
Callus related to hallux mtp-ip joints Callus related to lesser mtp-ip joints
No callus or asymptomatic 5 No callus or asymptomatic 5
Symptomatic 0 Symptomatic 0
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