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Principles of Bone
Cement and the Process
of Bone Cement Mixing
Welcome to
Principles of Bone
Cement and the Process
of Bone Cement Mixing
(An Online Continuing Education Activity)
CONTINUING EDUCATION INSTRUCTIONS
This educational activity is being offered online and may be completed at any time.
Steps for Successful Course Completion
To earn continuing education credit, the participant must complete the following steps:
1. Read the overview and objectives to ensure consistency with your own learning
needs and objectives. At the end of the activity, you will be assessed on the
attainment of each objective.
2. Review the content of the activity, paying particular attention to those areas that
reflect the objectives.
3. Complete the Test Questions. Missed questions will offer the opportunity to reread the question and answer choices. You may also revisit relevant content.
4. For additional information on an issue or topic, consult the references.
5. To receive credit for this activity complete the evaluation and registration form.
6. A certificate of completion will be available for you to print at the conclusion.
CONTACT INFORMATION:
2014
All rights reserved
Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014
www.pfiedlerenterprises.com
Phone: 720-748-6144 Fax: 720-748-6196
Overview
For the past 50 years, polymethylmethacrylate (PMMA) bone cements have been widely used
as the anchoring/grouting agent in total joint replacements of the hip, knee, ankle, elbow, and
shoulder. Good quality cement is essential for long-term implant survival and the role of the
perioperative nurse in preparing that cement is vitally important. Strict adherence to good
cement mixing and application techniques is a key factor in reducing the rate of loosening
and also in increasing the long-term survival of the prosthesis. The purpose of this continuing
education activity is to provide a review of key concepts regarding composition, properties,
and types of bone cements and factors that affect bone cement polymerization. The evolution
of mixing and application techniques also will be described. The activity concludes with a
discussion of potential hazards posed by bone cement and safety considerations for patients
and members of the surgical team.
OBJECTIVES
After completing this continuing nursing education activity, the participant should be able to:
1. Review the components of bone cement.
2. Describe the types of bone cement available today.
3. Outline the history of bone cement mixing systems.
4. Differentiate the various bone cement mixing systems and application techniques.
5. Identify the safety issues related to the use of bone cement in the perioperative
practice setting.
INTENDED AUDIENCE
This continuing education activity is intended for perioperative registered nurses who are
interested in learning more about bone cement and the process of bone cement mixing.
CREDIT/CREDIT INFORMATION
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing,
Provider Number CEP14944, for 2.0 contact hour(s).
Obtaining full credit for this offering depends upon completion, regardless of circumstances,
from beginning to end. Licensees must provide their license numbers for record keeping
purposes.
The certificate of course completion issued at the conclusion of this course must be
retained in the participants records for at least four (4) years as proof of attendance.
IAHCSMM
The International Association of Healthcare Central Service Materiel Management has
approved this educational offering for 2.0 contact hours to participants who successfully
complete this program.
3
IACET
Pfiedler Enterprises has been accredited as an Authorized Provider by the International
Association for Continuing Education and Training (IACET).
CEU Statements
As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its
programs that qualify under the ANSI/IACET Standard.
Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program.
This continuing education activity was planned and provided in accordance with
accreditation criteria. This material was originally produced in June 2014 and can
no longer be used after June 2016 without being updated; therefore, this continuing
education activity expires in June 2016.
DISCLAIMER
Accredited status as a provider refers only to continuing nursing education activities and
does not imply endorsement of any products.
SUPPORT
Grant funds for the development of this activity were provided by CardinalHealth
AUTHORS/PLANNING COMMITTEE/REVIEWER
Aurora, CO
Aurora, CO
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effective on March 27, 2008.
To directly access more information on our Privacy and Confidentiality Policy, type the
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contact us at:
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http://www.pfiedlerenterprises.com
INTRODUCTION
POLYMERIZATION
Working time is the interval between the dough and setting times, typically 5-8 minutes.
Previously, this represented the full time interval available for use of a particular mix of
bone cement. The use of mechanical introduction tools, such as syringes and cartridges,
extends this time by 1 to 1.5 min.4
Setting Phase/Setting Time
During this phase, the cement hardens (cures) and sets completely, and the temperature
reaches its peak. The cement continues to undergo both volumetric and thermal
shrinkage as it cools to body temperature. Hardening is influenced by the cement
temperature, the OR temperature, and the body temperature of the patient.
Setting time is the time point measured from the beginning of mixing until the time at
which the exothermic reaction heats the cement to a temperature that is exactly halfway
between the ambient and maximum temperature (ie, 50% of its maximum value), usually
about 8-10 minutes. The temperature increase is due to conversion of chemical to
thermal energy as polymerization takes place.5
Factors that Affect Dough, Working, and Setting Times
Factors that affect dough, working, and setting times include the following6:
Mixing Process Mixing that is too rapid can accelerate dough time and is not
desirable since it may produce a weaker, more porous bone cement.
Ambient Temperature Increased temperature reduces both dough and setting
times approximately 5% per degree Centigrade, whereas decreased temperature
increases them at essentially the same rate.
Humidity High humidity accelerates setting time whereas low humidity retards
it.
The combination of these factors is such that in a cold operating room on a very dry
winter day, setting time may stretch out and raise concerns as to whether there is
something wrong with the bone cement kit in use. There usually is not, but patience is
required under these conditions. Water (or anything else) should never be added to bone
cement in an attempt to modify its curing behavior.
Why Dont All Cements Behave the Same?
Despite the fact that basic PMMA bone cement materials are the same, the behavior of
various cement products can be significantly different when they are mixed under similar
conditions. There are several reasons for these differences:
The polymer component of a number of cements is not purely PMMA. Some
cement may contain PMMA copolymers such as methyl acrylate and styrene in
the powder and additional polymers such as butyl methacrylate. All cements are
labelled to show their ingredients.
The ratio of the components and the overall powder-to-liquid ratio may differ
between cements.
The size, shape and weight of the polymer molecules can vary considerably.
Manufacturing processes may differ.
Sterilisation method may differ (eg, gamma, and ethylene oxide gas sterilisation).
CEMENT PROPERTIES
Cement properties critical for operating procedures, such as viscosity change, setting
time, cement temperature, mechanical strength, shrinkage, and residual monomer, are
determined during polymerization. These properties will influence cement handling,
penetration, and interaction with the prosthesis. The most important properties are
discussed below.
Cement Porosity
Porosity is the fraction of the volume of an apparent solid that is actually empty space.
High bone cement porosity compromises the cements mechanical strength and
decreases its fatigue life. This may lead to aseptic loosening. Sources of porosity in
cured bone cement include:
Trapped air between the powder beads as the powder is wetted.
Trapped air in the cement during mixing.
Trapped air in the cement during transfer from mixing container to application
device.
Hand mixing bone cement in an open bowl may introduce the greatest possibility of
these occurrences, which is why hand-mixed cement can contain a substantial number of
pores. Centrifugation and vacuum mixing methods, and pressurized cement application
can decrease the porosity of bone cement.
Cement Viscosity
Viscosity is a measure of the resistance of a fluid to deformation under shear forces and
is commonly described as thickness of a fluid. Viscosity also represents the resistance
to flow and is thought to be a measure of fluid friction. Cement viscosity determines the
handling and working properties of the cement.
Mixing together the powder and the liquid components marks the start of the
polymerization process. During the reaction, the cement viscosity increases, slowly at
first, then later more rapidly. During the working phase, there are two requirements for
bone cement viscosity it must be sufficiently low to facilitate the delivery of the cement
dough to the bone site, and it must penetrate into the interstices of the bone.7 On the
other hand, the viscosity of the bone cement should be sufficiently high to withstand
the back-bleeding pressure, thus avoiding the risk of inclusion of blood into the cement
because this could significantly reduce the stability of the bone cement. It is important
that the cement retains an optimized viscosity for an adequate duration to allow a
comfortable working time.8
10
11
Fatigue
Fatigue is the failure of a component after it is subjected to a large number of alternating,
fluctuating loads; fatigue strength is a measure of a bone cements durability. If applied
only once, these loads would not be large enough to cause failure. A good example of
this is a paper clip, which when bent once will not break, but after it has been bent a
number of times, it will break easily.
As the cemented implant is subjected to not only static load but also dynamically
alternating loads, the fatigue properties of the cement affect survival of the implant.
Cement will have a natural lifespan and the repeated loads it is subjected to will, over
time, cause it to break down and fail. It is the quality of the cement mix that will determine
its lifespan. A well-mixed cement will be better equipped to deal with the loads placed
upon it.
The ability of bone cement to resist fatigue is critical given the loads to which it will be
subjected. Clinical evidence has documented the existence of fatigue cracks in revisionretrieved cement11,12 and in postmortem retrieved stem/cement/bone constructs.13 This
suggests that the fatigue resistance of bone cement should be optimized to prevent
fatigue failure.
Creep
Creep is the deformation of a material under constant load. Under constant load, a
material capable of creep will deform by an amount dependent on the size of the load
and the length of time it is applied. Creep generally increases with temperature. Creep
essentially is a mechanical problem that slowly and steadily can erode the long-term
performance of an implant. Cements with higher porosity are less resistant to creep
deformation.
Polymers are particularly susceptible to creep because of their molecular structure.
Therefore, bone cement, as a polymer, is likely to exhibit creep as it is under a load and
is at 37C in the body.
Significant bone cement creep will lead to implant subsidence, which, in turn, may lead to
failure.14 In the 1990s, a new formulation of bone cement had to be withdrawn after it was
found to significantly creep, leading to implant subsidence, aseptic loosening, and high
revision rates.15,16
Interestingly, a small degree of creep may in fact be advantageous in the early
postoperative stages with some implant designs. A polished, tapered stem without a
collar relies on some subsidence so that it becomes wedged in the bone cement,
thereby improving the load transfer mechanism.17
Stress
Stress is the load applied to a material over a given area. Stresses in the hip joint
are a combination of compression, bending, and torsional (twisting) forces. As load is
transferred during walking, the new joint and cement will be subjected to high stresses.
If these high stresses exceed the strength of the cement, it will deform permanently and
then, possibly, fail.
12
Cements can be grouped as high, medium, or low viscosity, with or without antibiotics.
The viscosity designation refers to the viscosity of the powder and liquid during the
mixing phase: high-viscosity cement is dough-like, while low-viscosity cement is more
like a liquid. The handling phases of different viscosity cements also vary considerably
and the choice of which cement to use is often surgeon preference. For example, a 2006
national survey of 587 surgeons in the UK found that high-viscosity cement was used
in total hip arthroplasty by 82% of the surgeons, medium-viscosity cement by 12%, and
low-viscosity cement was used by 6%.18
High Viscosity
High-viscosity bone cements have a short mixing phase and lose their stickiness quickly.
This makes for a longer working phase. The viscosity remains constant until the end of
the working phase. The setting phase lasts between one minute 30 seconds and two
minutes.19 High-viscosity cements are associated with reduced revision rates for total hip
arthroplasty.20
Medium Viscosity
These cements typically have a long waiting phase of three minutes, but during the
working phase, the viscosity only increases slowly. Setting takes between one minute 30
seconds, and two minutes 30 seconds.21
Low Viscosity
Low-viscosity cements have a long waiting phase of three minutes and the viscosity
rapidly increases during the working phase, making for a short working phase. As
a consequence, application of low-viscosity cements requires strict adherence to
application times. The setting phase is one to two minutes long.22
Antibiotic Cements
Periprosthetic infection is the most feared complication in total hip and knee replacement.
The infection usually leads to a complete failure of the joint replacement, resulting in
a long series of operative procedures, great discomfort for the patient, and significant
costs.
The use of antibiotic-impregnated bone cement to treat musculoskeletal infection has
been reported in the literature for more than three decades despite the fact that it wasnt
until 2003 that the first pre-blended bone cement containing an antibiotic (tobramycin)
became available for sale in the United States, specifically for the treatment and
reimplantation of infected arthroplasties.23,24 Prior to 2003, U.S. surgeons prepared
antibiotic cement on-site (ie, in the operating room) by adding antibiotic powder to the
powdered bone cement prior to the addition of the liquid monomer. In Europe, however,
pre-blended antibiotic bone cements have been available since the 1970s and the
indications and scientific evidence for its use have expanded to primary arthroplasty
to minimize postoperative infection. Use of antibiotic cements for primary arthroplasty,
13
however, remains controversial in the United States. The primary arguments proffered
against the routine use of antibiotic bone cement are lack of efficacy, adverse effects on
mechanical properties, increased costs, bacterial resistance, and systemic toxicity.25,26
However, there is significant evidence to refute these arguments.27,28,29
The elution of antibiotics from PMMA bone cement can be affected by certain factors
including the type of cement used, preparation methods, surface characteristics, porosity
of the cement, and the amount and/or type of antibiotics used.30
Not all antibiotics are suitable for use in bone cements. The following bacteriologic and
physical and chemical factors should be considered in the choice of an antibiotic31:
Preparation must be thermally stable and able to withstand the exothermic
temperature of polymerization.
Must have broad antimicrobial coverage.
Must be available as a powder.
Must have a low incidence of allergy.
Must not significantly compromise mechanical integrity.
Must elute from the cement over an appropriate period of time.
Gentamicin and tobramycin are the only antibiotics available in U.S. commercial antibiotic
bone cement products; tobramycin is the most often used and studied antibiotic added
to cement worldwide, but gentamicin is more common in the United States.32 Other
antibiotics (singly or in combination with other antibiotics) that have been studied include
vancomycin, cephalothin, clindamycin, meropenem, teicoplanin, ceftazidime, imipenem,
piperacillin, and ciprofloxacin.33,34,35
by stirring during hand spatulation. In order to reduce both the harmful fumes as well as
the introduction of air into the cement mixture, the closed bowl technique, using a paddle
mixing system and wall suction to evacuate the fumes, was developed.
Vibration
During the 1980s, a vibrating mixing technique was introduced in hopes of improving
bone cement properties. The results, however, were not convincing.38
Centrifugation
In this technique, cement was first mixed manually and then subjected to centrifugation
to eliminate any air inclusions introduced during mixing and thus reduce porosity in
hopes of improving compressing strength and handling properties. The technique
required chilling the liquid monomer prior to mixing in order to negate the shortening
effect of centrifugation on setting time. The resulting low-viscosity mixture then was
introduced into a cement syringe, which was centrifuged at high speed for a short period
of time. The method succeeded in reducing porosity but procedures varied significantly
depending on the type of centrifugation and cement used.
Vacuum Mixing
Also in the 1980s, mixing under vacuum was introduced to reduce exposure to fumes
while also improving tensile strength and fatigue life of bone cement.39,40,41,42 After some
refining, it produced better results than centrifugation, which was soon thereafter retired
in favor of vacuum mixing43 and quickly became the preferred method of mixing. For
example, a 2006 national survey of 587 surgeons in the UK found that 94% were using
vacuum mixing systems for bone cement preparation with total hip arthroplasty.44
In most operating rooms today, bone cement is mixed under a vacuum, which results in a
low porosity cement with increased strength and resistance to cement fatigue and creep.
Trying to eliminate all of the porosity by using a very high vacuum level can promote
excessive shrinkage and cracking.
With a vacuum mixing system, the cement is mixed in a syringe, bowl, or cartridge. All of
these systems consist of an enclosed chamber connected to a vacuum source (eg, wall
suction or a dedicated vacuum pump). All ingredients are added and mixed while the
system is closed.
The methods for application of bone cement include hand packing, injection, and gun
pressurization.
Hand packing The original method for hip arthroplasty was hand packing,
where cement in the femoral canal was finger packed. The proximal end was
packed with cement by pressing with the fingers or thumbs; this pressurization
forced the cement into the bone interstices. Cementing in total knee arthroplasty
is still commonly hand-packed because the surfaces are readily visualized, which
makes the application with pressure by hand feasible.
Injection Syringes are used to apply, or inject, the cement.
15
The components of PMMA bone cement (powder and liquid MMA monomer) are toxic
and highly flammable. As a consequence, perioperative personnel must be aware of the
potential hazards for both personnel and patients in the OR environment. Appropriate
safety precautions must be implemented to reduce the risk of exposure and to monitor
patient reactions closely. The specific hazards associated with the use of PMMA bone
cement are described below.
Flammability/Combustion Hazards
As packaged, the product is considered stable. Nevertheless, the powder component
is combustible and sensitive to static discharge. The liquid component is a volatile
flammable liquid that slowly attacks rubber. The liquid will polymerize very readily and all
contamination must be avoided, particularly organic peroxides, catalysts, free radicals
generators and multivalent metal oxides, especially when wet. Heat and strong light,
particularly fluorescent or UV, could cause polymerization.45 The operating room should
be adequately ventilated to eliminate monomer vapors. Ignition of monomer vapors
caused by the use of electrocautery devices in surgical sites near freshly implanted bone
cement has been reported.46
Health Risks to Personnel47
Caution should be exercised during the mixing of the liquid and powder components
of the PMMA bone cement to prevent excessive exposure to the concentrated vapors
of the liquid methylmethacrylate (MMA) monomer, which may produce irritation of the
respiratory tract, eyes, and possibly the liver. MMA fumes, which are emitted during
preparation of PMMA bone cement, have been shown to have toxic side effects ranging
from allergic reactions to neurological disorders. Although there is no evidence for
potential carcinogenicity of the substance, all efforts should be made to reduce the
exposure.48 The permissible exposure limit (PEL) value established by OSHA is a timeweighted average limit of 100 parts of MMA per million (ppm) of air or a time-weighted
average of 410 milligrams of MMA per cubic meter of air during any 8-hour work shift in a
40-hour work week.49
Skin contact with the liquid monomer can cause contact dermatitis and hypersensitivity
reactions. The MMA monomer is a powerful lipid solvent. It should not contact rubber or
latex gloves. Double gloving or use of special gloves resistant to the monomer, and strict
adherence to the mixing instructions may diminish the possibility of contact dermatitis
and hypersensitivity reactions. The mixed PMMA bone cement should not contact the
gloved hand until the cement has acquired the consistency of dough.
16
Eye contact with the liquid can be quite serious, causing considerable irritation or
burns to the eyes. Soft contact lenses are very permeable and should not be worn
where methylmethacrylate is being mixed because the lenses are subject to pitting and
penetration by the vapors. Personnel wearing soft contact lenses should not mix PMMA
bone cement or be nearby.
Health Risks to Patients
According to the U.S. Food and Drug Administration (FDA),
Serious adverse events, some with fatal outcome, associated with the use of the
PMMA bone cement include myocardial infarction, cardiac arrest, cerebrovascular
accident, and pulmonary embolism. The most frequent adverse reactions
are transitory decreased blood pressure, elevated serum gamma-glutamyltranspeptidase (GGTP) up to 10 days postoperation, thrombophlebitis, hemorrhage
and hematoma, pain and/or loss of function, loosening or displacement of the
prosthesis, superficial or deep wound infection, trochanteric bursitis, short-term
cardiac conduction irregularities, heterotopic new bone formation, and trochanteric
separation. Other potential adverse events associated with the use of PMMA
bone cement include allergic pyrexia, hematuria, dysuria, bladder fistula, delayed
sciatic nerve entrapment from extrusion of the bone cement beyond the region of
its intended application, local neuropathy, local vascular erosion and occlusion,
intestinal obstruction because of adhesions and stricture of the ileum from the heat
released during the exothermic polymerization.50
Hypotensive reactions can occur between 10 and 165 seconds after application of
the PMMA bone cement and can last for 30 seconds to 5 or more minutes. Some
hypotensive reactions have progressed to cardiac arrest. The blood pressure of patients
should be monitored carefully during and immediately following the application of the
PMMA bone cement. In addition, overpressurization of the PMMA bone cement should
be avoided during insertion of the PMMA bone cement and implant in order to minimize
the occurrence of pulmonary embolism.51
Bone cement implantation syndrome (BCIS) is a poorly dened, poorly understood,
rare, and potentially fatal intraoperative complication occurring in patients undergoing
cemented orthopaedic surgeries.52,53 It can occur within minutes of the procedure; it also
may be seen in the postoperative period in a milder form causing hypoxia and confusion.
BCIS has no agreed upon definition; it is characterized by a number of clinical features
that may include hypoxia, hypotension, cardiac arrhythmias, increased pulmonary
vascular resistance (PVR), and cardiac arrest. It is most commonly associated with,
but is not restricted to, hip arthroplasty. It usually occurs at one of the five stages in
the surgical procedure; femoral reaming, acetabular or femoral cement implantation,
insertion of the prosthesis, or joint reduction.54
17
18
SUMMARY
PMMA bone cement has been used in cemented arthroplasty procedures for over 50
years. Good quality cement is essential for long-term implant survival and the role of
the perioperative nurse in preparing that cement is vitally important. The quality of bone
cement is determined by several factors, including the type of cement selected, (ie,
viscosity, presence of antibiotics) and strict adherence to instructions provided by the
manufacturer. Its effectiveness is highly dependent upon the use of optimal mixing and
application techniques. The components of PMMA bone cement (powder and liquid MMA
monomer) are toxic and highly flammable. As a consequence, perioperative personnel
must be aware of the potential hazards for both personnel and patients in the OR
environment. Appropriate safety precautions must be implemented to reduce the risk of
exposure and to monitor patient reactions closely.
19
GLOSSARY
Accelerator
Copolymer
Creep
Dough Time
Exothermic Reaction
Fatigue
High-Viscosity Cements
Laminations
20
Low-Viscosity Cements
Medium-Viscosity Cements
Methylmethacrylate (MMA)
Mixing Phase
Monomer
Polymethylmethacrylate (PMMA)
21
Porosity
Setting Phase
Setting Time
Stress
Viscosity
Waiting Phase
Working Phase
Working Time
22
REFERENCES
24
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25
26
51. U.S. Food and Drug Administration [FDA]. Medical Devices; Reclassification
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dockets/98fr/071702c.htm. Accessed January 20, 2014.
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syndrome. British Journal of Anaesthesia. 2009;102(1):12-22.
53. Razuin R, Effat O, Shahidan MN, Shama DV, Miswan MF. Bone cement implantation
syndrome. Malaysian Journal of Pathology. 2013;35(1):87-90.
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syndrome. British Journal of Anaesthesia. 2009;102(1):12-22.
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Standards and Recommended Practices. Denver, CO: AORN, Inc;2013;217-242.
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