192 ORTHOPEDICS PROSTHESIS FIXATION FOR

ORTHOPEDICS PROSTHESIS FIXATION FOR

PATRICK J. PRENDERGAST
Trinity Centre for
Bioengineering
Dublin, Ireland

INTRODUCTION

The fixation of an orthopedic implant should secure it

rigidly to the underlying bone. The ideal fixation will
sustain high forces, pain free, for the remaining lifetime
of the patient. Difficulties in achieving this objective arise
because (1)

1. The loads are often several times body weight in the

lower extremity.The loads are fluctuating, or cyclic,
and furthermore extremely high loads can occur
occasionally (2).

Encyclopedia of Medical Devices and Instrumentation, Second Edition, edited by John G. Webster
Copyright # 2006 John Wiley & Sons, Inc.

2. The presence of the implant alters the stress transfer
to the underlying bone leading to bone remodelling or
fibrous tissue formation at the bone/implant inter-
faces. This can threaten the long-term mechanical
integrity of the prosthetic replacement.
3. The range of materials that can be placed in contact
with bone is limited by biocompatibility issues.
The fixation of an orthopedic implant may be catagor-
ized as either cemented fixation or biological fixation.
Cemented fixation involves securing the implant into
the bone with a ‘‘bone cement.’’ By far the most common
bone cement is based on the (polymer polymethylmetha-
crylate (PMMA)). PMMA bone cement is polymerized in
situ during the surgery. It contains radiopacificiers in the
form of particles of barium sulphate (BaSO4) or zirconia
(ZrO2), which make it visible in radiographs (3). It also
contains an inhibitor (hydroquinone) to prevent sponta-
neous polymerization and an initiator (benzoyl peroxide) to
allow polymerization at room temperature. Antibiotics to
prevent infection (e.g., gentimacin) may also be added.
Table 1 lists typical components of bone cement and their
roles. Polymerization begins when a powder of the PMMA
polymer is mixed with the MMA monomer liquid. The
mixing can either be done by hand in a mixing bowl just
before to its use in the surgery or a mechanical mixing
system may be used; these have the advantage of reducing
the porosity of the bone cement and increasing its fatigue
life. The cement is applied in a doughy state to the bone
before placement of the implant.
In biological fixation, the implant is secured to the bone
by a process known as ‘‘osseointegration.’’ Osseointegra-
tion occurs by bone ingrowth onto the surface of the
implant. The surface of the implant must have a structure
so that, when the bone grows in, sufficient tensile and
shear strength is created. Bone ingrowth requires a
mechanically stable environment and an osteoconductive
surface. An osteoconductive surface can be achieved by
various treatments, e.g., plasma spraying with hydroxya-
patite. Ingrowth occurs over approximately 12 weeks, and
during this period, implant stability is required: Initial
stability can be achieved by press-fitting the implant into
the bone, or by using screws.
Hybrid fixation refers to the use of both cemented and
biological techniques for the fixation of a prosthesis. For
example, a hip replacement femoral component may be
Table 1. Components of Bone Cement and Their Roles
Components
Liquid
Methyl methacrylate (monomer)
N,N,-dimethyl-p-toluidine
Hydroquinone
Solid powder
Polymethyl methacrylate
Methyl methacrylate-styrene-copolymer
Barium sulphate (BaSO4), USP
Dibenzoyl peroxide
From Park (3).
Note: v/o: % by volume; w/o: % by weight.
ORTHOPEDICS PROSTHESIS FIXATION FOR 193
fixated using cement, whereas the acetabular cup may be
fixated into the pelvic bone by osseointegration.
Failure of prosthesis fixation is observed as loosening
and pain for the patient. If loosening occurs without infec-
tion it is called aseptic loosening. Loosening is a multi-
factorial process and does not have just one cause.
Loosening of cemented fixation often occurs by fatigue
failure of the bone cement, but loosening can have several
root causes: fatigue from pores in the cement and stress
concentrations at the implant/cement interface, debonding
at the prosthesis/cement interface or cement/bone inter-
face, or bone resorption causing stresses to rise in the
cement. Loosening of biological fixation occurs if the rela-
tive micromotion between the bone and the implant is too
high to allow osseointegration, i.e., if the initial stability of
the implant is insufficient. Huiskes (4) proposed the con-
cept of failure scenarios as a method for better under-
standing the multifactorial nature of aseptic loosening.
The failure scenarios are
1. Damage accumulation failure scenario: the gradual
cracking of bone cement, perhaps triggered by inter-
face debonding, pores in the cement, or increased
stresses due to peripheral bone loss.
2. Particulate reaction failure scenario: wear particles
emanating from the articulating surfaces or from
metal/metal interfaces in modular prostheses (fret-
ting wear) can migrate into the interfaces causing
bone death (osteolysis).
3. Failed ingrowth failure scenario: High micromotion
of the implant relative to the bone can prevent bone
ingrowth, as can large gaps (> 3 mm). If the area of
ingrowth is insufficient, then the strength of the
fixation will not be high enough to sustain loading
when weight-bearing commences.
4. Stress shielding failure scenario: Parts of the bone
can be ‘‘shielded’’ from the stresses they would nor-
mally experience because of the rigidity of the
implant. This can lead to resorption of the bone
and degeneration of the fixation.
5. Stress bypass failure scenario: In biological fixation,
ingrowth can be patchy leading to stress transfer
over localized areas. When this happens, some bone
tissue is ‘‘bypassed,’’ and in these regions, bone atro-
phy can occur because the stress is low.
Role Amount
20 mL
Wetting PMMA particles 97.4 v/o
Polymerization accelerator 2.6 v/o
Polymerization inhibitor 75 þ 15 ppm
40 g
Matrix material 15.0 w/o
Matrix material 75.0 w/o
Radiopacifying agent 10.0 w/o
Polymerization initiator 0.75 w/o
194 ORTHOPEDICS PROSTHESIS FIXATION FOR

6. Destructive wear failure scenario: In some joint 30

replacement prostheses, e.g., hip and knee, wear
can occur to such a degree that the component even- 25
tually disintegrates.

Stress (MPa)
20

CEMENTED FIXATION 15

It is common to classify cementing techniques according to 10 Hand-mixed

‘‘generation’’: The first generation involved hand-mixing
Vacuum-mixed
and finger packing of the cement, and the second genera- 5 Hand-mixed
tion improved the procedure by using a cement gun and Vacuum-mixed
retrograde filling of the canal, with a bone-plug to contain 0
the cement within the medullary canal. This allows pres- 0 10 10
2
103 104 105 106
surization of the cement and therefore better interdigita- Cycles to Failure (Nf)
tion of the cement into the bone. Third generation (called
modern cementing) uses, in addition, mechanical mixing Figure 2. A comparison of the fatigue strength of hand-mixed and
techniques for the cement to remove pores and pulsative vacuum-mixed bone cement. After Murphy and Prendergast (10).
lavage to clean the bone surface of debris. The most com-
mon mechanical mixing technique is ‘‘vacuum mixing,’’
interdigitation, it was thought useful to develop ‘‘low visc-
where the powder and monomer are placed together in a
osity’’ cements, and although higher penetration was
mixing tube and the air is removed under pressure; often
achieved, the clinical outcomes using low viscosity cements
the tube can then be placed into an injection gun from
in hips were not superior (6).
which it can be extruded into the bone cavity. Another
PMMA bone cement undergoes an exothermic polymer-
mechanical mixing technique is centrifugation (i.e., spin-
ization reaction. This means that heat is produced on
ning the polymerizing bone cement in a machine), which is
polymerization and this can cause necrosis of the surround-
found to remove pores and increase the fracture strength
ing bone tissue. Another consequence of heating is that the
(3). Precoating the implant with a PMMA layer or addition
cement expands and contracts on cooling. As solidification
of a roughened surface strengthens the implant/bone
occurs before to full cooling, residual stresses are generated
cement interface.
in the cement (7). This is one reason to minimize
Fixation strength using bone cement relies on an inter-
the thickness of the cement layer. Also, metallic stems,
digitation of the bone cement with the bone; i.e., it is a
because they conduct heat, can minimize the peak tem-
mechanical interlock between the bone and the solidified
perature transmitted to the bone, cooling the metallic
cement that maintains the strength and not a chemical
implant before implantation has also been suggested.
bond. Good interdigitation requires that the bone bed be
Bioactive cements have also been proposed; see the review
rough. Creating a rough surface is done by appropriate
by Harper (8). These cements have filler particles added to
broaching during preparation of the bony bed; it also
create a bioactive surface on the cement; fillers can be
requires lavage to clean the bed of loose debris and marrow
hydroxyapatite powder or fibers, bone particles, or human
tissue. Mann et al. (5) found the strength of the bone
growth hormone. Alternatives to PMMA are bisphenol-a-
cement/bone interface to be positively correlated with
glycidyl methacrylate (BIS-GMA) or poly(ethylmethacry-
the degree of interdigitation (Fig. 1). To achieve superior
late) (PEMA)/n-butylmethacrylate (nBMA) cement. How-
ever, these cements are not yet widely used.
3
The mechanical strength depends on the brand of
Apparent strength, sapp (MPa)

θ = 0˚ cement used and on the mixing technique (9). To prevent

2.5 the damage accumulation failure scenario (see above),
sufficient fatigue strength is required. This has been mea-
2 sured as a function of mixing technique (Fig. 2) (10). Being
a polymer operating close to its melting temperature, bone
1.5
cement is also subject to creep, i.e., viscoplasticity, and the
1 creep strain as a function of stress has been measured
under dynamic loading (11). However, it is clear that the
.5 in vitro testing conditions may not account for many of the
extremely complex in vivo conditions, so these results
0
0 100 200 300 400 500 600 700
should be interpreted with caution (12).
qint (mg/cc-mm)
OSSEOINTEGRATION (CEMENTLESS FIXATION)
Figure 1. Interdigitation of the bone cement into the bone
increases the strength of the bone cement interface. qint is the
product of the average value of the thickness of the interdigitated There is no simple definition of osseointegration, although
region and the density of the interface region measured using a CT Albrektsson (13) advocates the following: Osseointegration
scan. See Mann et al. (5) for details. means a relatively soft-tissue-free contact between implant

Figure 3. Bone ingrowth into a multilayer of a proximal part of a
femoral hip prosthesis. After Eldridge and Learmonth (15).
and bone, leading to a clinically stable implant. Early in
the study of the osseointegration concept, Skalak (14)
found osseointegration was promoted by a micro-rough
surface more so than a smooth one. Since then, many
animal experiments investigating the effect of plasma
spraying the surface and various methods of creating a
porous surface have been reported. For orthopedic fixation,
porous surfaces with beads in one or more layers have been
used, as have wire meshes attached to surfaces, and
plasma spraying the surface with hydroxyapatite.
Figure 3 shows bone ingrowth into a multilayer of a
proximal part of a femoral hip prosthesis (15). It can be
observed that ingrowth is patchy; this is what is commonly
found, even with successful implants retrieved at autopsy
(16); it is evident, therefore, that ingrowth is not required
everywhere on the prosthesis for a successful fixation.
Ingrowth is controlled by a combination of the mechanical
environment and the size of the pores; the spacing between
the pores should not be greater than the degree of micro-
motion or else the new bone ingrowth path will be con-
tinuously sheared as the tissue attempts to grow in. In
experiments in dogs, Søballe (17) studied the relationship
between implant coating and micromotion and found that
hydroxyapatite coating increased the rate of bone
ingrowth, and that a relative motion between implant
and bone of 150 mm allowed osseointegration, whereas a
relative motion of 500 mm inhibited it. The mechanobiolo-
ORTHOPEDICS PROSTHESIS FIXATION FOR 195
gical consequences of these different shearing magnitudes
was analyzed by Prendergast et al. (18). The depth of the
porosity will also affect the strength, with multilayer
beaded surfaces having the potential for greater tensile
strength (1).
FIXATION OF PROSTHESIS DESIGNS
Each implant design has specialized fixation features. In
the following sections, examples are provided of the fixa-
tion approaches used in the main orthopedic implant cate-
gories.
Hip Prostheses
Although hip arthroplasty may involve replacement of the
femoral side only, total hip arthroplasty (THA) involves
replacement of the proximal femur and the acetabular
socket. Both cemented and cementless fixation is used
for both the femoral component (the ‘‘stem’’) and the acet-
abular component (the ‘‘cup’’). Selection is a matter of
surgeon choice, although there is some agreement that
the cementless fixation is preferable in younger patients
because cementless implants are easier to revise than
cemented where complete removal of the cement mantle
may be problematic.
Considering the femoral side first, cemented fixation
takes two categories: stem designs in which a bond is
encouraged between the stem and the cement (referred
here as bonded stems) and designs that discourage a bond
(referred here as unbonded stems). Stem bonding can be
achieved through roughening of the stem surface to create
a mechanical interlock between the metallic stem or
cement or through use of a PMMA precoat to create a
chemical bond between the precoat/cement interface.
Bonded stems usually contain a collar that rests on the
bone surface preventing subsidence and often containing
ridges, dimples, and undercoats to provide additional inter-
lock with the cement. As long as the bonded stems remain
bonded, they have the theoretical benefit of reducing the
stress levels in the cement. However, if the bonded stems
fail, the roughened surface could generate debris particles
and initiate a loosening process. In contrast to the bonded
stems, unbonded stems discourage a bond between
the stem and the cement through use of a smooth, polished
stem surface in combination with a stem design that
typically has no collar or macrofeatures to lock into the
cement. With the lack of a bond, the polished stems facil-
itate some stem subsidence within the cement mantle and
thereby allow wedging of the implant within the medullary
canal. Lennon et al. (19) compared the damage accumula-
tion around polished with matt stems and did not find a
difference in the damage accumulated in their cement
mantles. Another point of comparison between cemented
and cementless fixation is that cementless stems will have
a larger cross-sectional area than cemented stems because
they must fill the medullary canal; this will make cement-
less hip prostheses stiffer and predispose them to the stress
shielding failure scenario. Recognizing this, it is usual for
the osseointegration surface to be on the proximal part of
cementless stems to ensure proximal load transfer;
196 ORTHOPEDICS PROSTHESIS FIXATION FOR

furthermore, patches of osseointegrative surface may be

limited to the posterior and anterior faces of the stem.
Considering the acetabular side, the cup is either made
from ultra-high-molecular-weight polyethylene (UHMWPE),
ceramic, or metal. UHMWPE cups may be metal-backed.
As the head can be either ceramic (a modular head can be
connected to a metal femoral component using a Morse
taper) or metal (modular or monobloc), this means that
several combinations of bearing materials are possible.
Polyethylene cups and metal heads are the most common,
but the others, such as metal-on-metal, are advocated as
well. The selection of bearing materials is important for
the fixation because a high frictional torque predisposes
to loosening of the cup or stem and because the wear
particles produced can provoke the particulate reaction
failure scenario. Polyethylene cups are cemented into
the acetabulum using bone cement. Metal-backing of the
cup is designed to decrease stresses in the polyethylene
‘‘liner,’’ which should lead to lower wear rates although it
is also predicted to increase stress concentrations in the
fixation at the periphery of the cup (20). Metal, ceramic, Figure 4. A knee replacement prosthesis showing porous-coating
and metal-backed UHMWPE cups may be threaded on the for osseointegration and posts for fixation. From Robinson (23).
outside so that they can be screwed into the acetabelum, or
they may be fixated by osseointegration.
The interrelationship between design factors and fixa- fixation is used in knee arthroplasty. The femoral compo-
tion of hip implants is complicated and involves maximiz- nent may be fixated with an intramedullary stem that may
ing strength of the cement/metal interface, the cement be cemented, or it may have a porous surface for osseointe-
itself, and the bone/cement interface. According to the gration with medial and lateral ‘‘posts’’ to aid initial sta-
design philosophy of polished stems, it is better to safe- bility. The tibial component consists of a metal ‘‘tray’’ and a
guard the vital bone/cement interface by allowing the polyethylene insert; the tray may also be fixated with an
cement/metal interface to fail first and facilitating subsi- intramedullary stem cemented into the tibia, perhaps
dence (21). Not only should the interfaces have the accompanied by medical and lateral posts/pegs for rota-
required strength, but the stresses should be minimized tional stability. Figure 4 shows a design fixated by osseo-
to ensure the most durable fixation (22)— the measures to integration (23). Walker (24) gives a thorough description
achieve this are listed in Table 2. of the options available for knee prostheses.

Knee Prostheses Upper Extremity and IVD Prostheses

Total knee replacement involves femoral and tibial compo- Upper extremity prostheses include the shoulder, elbow,
nents, and a component for patellar resurfacing (a patellar and wrist (1). Total shoulder arthroplasty (TSA) consists of
‘‘button’’) is also often used. Both cemented and cementless a humeral component with an intermedullary stem and a

Table 2. Measures that Maximize Strength and Minimize Stress in Total Hip Replacement Structures
Cement/Metal
Interface Cement Cement/Bone Interface

Maximize Grit-blasted metal Optimal preparation Careful reaming

strength
Minimize stress Reduce patient weight
Adapted from Huiskes (22).
PMMA-coated metal Pressurization Pressurization
Cement restrictor Minimal polymerization heat
Minimal monomer
Bone lavage
Minimal wear debris
Reduce patient activity
Anatomical reconstruction of the femoral head
Minimal friction
No impingement or subluxation
Bonded cement/metal interface
Optimal implant and cement mantle design
Optimal implant material
Optimal (reproducible) placement

glenoid component inserted into the glenoid cavity of the
scapula. The glenoid component is either all-polyethylene;
in which case, it is cemented; or metal-backed; in which
case, it may be fixated by osseointegration. Glenoid com-
ponents may have several pegs, or they may have one
central ‘‘keel’’ for fixation (25). Elbow prostheses consist
of humeral, ulnar, and radial components, all which may be
fixated with or without cement. Wrist prostheses replaces
the radial head and the schapoid and lunate bones of the
wrist and may be cemented and uncemented (1). Inter-
vertebral disk (IVD) prostheses replace the degenerated
disk with a polymer; there are several strategies for fixa-
tion: The endplates may be porous coated and plasma
sprayed for osseointegration to the cancellous bone with
vertical fins to increase stability. IVD prostheses may also
be fixed to adjacent vertebral bodies with screws (26).
EVALUATION OF FIXATION AND FUTURE STRATEGIES
One of the key issues in orthopedic implant fixation is
whether to use cemented fixation or biological fixation,
with surgeons on both sides of the debate (16,27). Cemen-
ted fixation has the advantage of immediate postoperative,
stability whereas concerns may be raised about the relia-
bility of bone cement’s fatigue strength; furthermore,
there is a school of thought that the exothermic polymer-
ization reaction should be avoided if at all possible. Bio-
logical fixation by osseointegration has the advantage of
avoiding the use of the PMMA cement but runs the risk of
the failed ingrowth failure scenario; furthermore,
immediate postoperative weight-bearing is not possible.
Finally cementless implants are easier to revise if
they fail.
Another key issue in orthopedic implant fixation is that
of preclinical testing and regulatory approval of new fixa-
tion technologies. Considerable challenges exist in achiev-
ing consensus around regulatory tests that safeguard
patients against ineffective devices while still allowing
innovation (4). Preclinical tests can use either (1) finite
element models of the direct postoperative situation, e.g.,
for the hip (28), knee (29), or shoulder (25), or computer
simulations of a failure scenario, e.g., damage accumula-
tion (30); (2) physical model ‘‘bench’’ testing with simula-
tors (24,31); or (3) animal testing. Animal testing is not
ideal for testing the biomechanical efficacy of orthopedic
implant fixation because the implant geometry must be
modified to fit the animal skeleton. Furthermore, an impor-
tant emerging concept is that of patient-specific implants
based on computational analysis of a patient’s medical
images (32).
One useful clinical method to assess implant fixation is
through the use of radiostereometric analysis (RSA). With
this approach, the migration of the implant relative to the
bone can be determined and is used to determine designs
that may be at risk of early loosening. Retrospective and
prospective clinical studies are also very useful to deter-
mine designs or materials that have promising or poor
clinical results. On a larger scale, implant registries per-
formed in many countries in Western Europe can provide
information on how designs, materials, and surgical tech-
ORTHOPEDICS PROSTHESIS FIXATION FOR 197
niques rank in terms of risk of failure. All of these clinical
tools can aid in understanding the role of implant fixation
in success of joint replacements.
A final issue is the degree to which broader technological
innovations in surgery and medicine will affect ortho-
pedics. For example, minimally invasive therapy (33)
requires special implants and associated instrumentation.
Tissue-engineering and regenerative medicine also has the
potential to change the nature of orthopedics, not only by
reducing the need for joint arthroplasty implants but by
integrating tissue engineering concepts with conventional
implant technologies, for example, cell seeding into
implant surfaces to promote biological fixation.
ACKNOWLEDGMENTS
Research funded by the Programme for Research in Third-
Level Institutions, administered by the Higher Education
Authority. Dr. A. B. Lennon and Ms. S. Brown are thanked
for their comments.
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See also BIOCOMPATIBILITY OF MATERIALS; BONE AND TEETH, PROPERTIES

OF; BONE CEMENT, ACRYLIC; HIP JOINTS, ARTIFICIAL; MATERIALS AND DESIGN
FOR ORTHOPEDIC DEVICES.