Principles of Bone Cement and the Process of Bone Cement Mixing

8/17/2019 Principles of Bone Cement and the Process of Bone Cement Mixing

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An Online Continuing Education Activity

Sponsored By

Grant funds provided by

Principles of BoneCement and the Process

of Bone Cement Mixing C E O N L I N

E


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Welcome to

PRINCIPLES OF BONE

CEMENT AND THE PROCESSOF 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

reect the objectives.

3. Complete the Test Questions. Missed questions will offer the opportunity to re-read 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 certicate of completion will be available for you to print at the conclusion.

Pedler Enterprises will maintain a record of your continuing education credits

and provide verication, if necessary, for 7 years. Requests for certicates mustbe submitted in writing by the learner.

If you have any questions, please call: 720-748-6144.

CONTACT INFORMATION:

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All rights reserved

Pedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014

www.pedlerenterprises.com

Phone: 720-748-6144 Fax: 720-748-6196


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OVERVIEWFor 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 perioperativepractice setting.

INTENDED AUDIENCEThis 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

Pedler 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 certicate of course completion issued at the conclusion of this course must beretained in the participant’s 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.


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IACET

Pedler 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, Pedler Enterprises offers CEUs for itsprograms that qualify under the ANSI/IACET Standard.

• Pedler Enterprises is authorized by IACET to offer 0.2 CEUs f or this program.

RELEASE AND EXPIRATION DATEThis 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 continuingeducation 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.

SUPPORTGrant funds for the development of this activity were provided by CardinalHealth

AUTHORS/PLANNING COMMITTEE/REVIEWERSusan K. Purcell Littleton, CO

Medical Writer/Author

Julia A. Kneedler, RN, MS, EdD Aurora, CO

Program Manager/Reviewer

Pedler Enterprises

Judith I. Pster, RN, BSN, MBA Aurora, CO

Program Manager/Planning Committee

Pedler Enterprises


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THOSE IN A POSITION TO CONTROL CONTENT FOR THIS ACTIVITYPedler Enterprises has a policy in place for identifying and resolving conicts of interest

for individuals who control content for an educational activity. Information listed below is

provided to the learner, so that a determination can be made if identied external interestsor inuences pose a potential bias of content, recommendations or conclusions. The intent

is full disclosure of those in a position to control content, with a goal of objectivity, balance

and scientic rigor in the activity.

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the subject matter that may be presented in this educational activity. “Relevant nancial

relationships” are those in any amount, occurring within the past 12 months that create a

conict of interest. A “commercial interest” is any entity producing, marketing, reselling,

or distributing health care goods or services consumed by, or used on, patients.

Activity Planning Committee/Authors/Reviewers:

Julia A. Kneedler, RN, MS, EdD

Co-owner of company that receives grant funds from commercial entities

Susan K. Purcell, MA

No conict of interest.

Judith I. Pster, RN, BSN, MBA

Co-owner of company that receives grant funds from commercial entities


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INTRODUCTIONPolymethylmethacrylate (PMMA) bone cement is an essential component in many total

joint arthroplasty procedures. In a cemented arthroplasty, the main functions of the

cement are to immobilize the implant, transfer body weight and service loads from the

prosthesis to the bone, and increase the load-carrying capacity of the prosthesis-bone

cement-bone system. The term “cement,” however, is misleading since bone cement

acts more like a grout, lling in space in order to create a tight space to hold the implant

against bone. Good quality cement is essential for long-term implant survival and the role

of the perioperative nurse in preparing that cement is vitally important. Accurate bone

cement mixing and precise application techniques are critical to ensuring the stability and

longevity of the prosthesis. Since bone cement is prepared and used in the operating

room (OR) environment, it is important that all perioperative personnel recognize the

unique safety considerations that are related to its preparation and its use.

COMPONENTS OF BONE CEMENTPMMA bone cements are usually supplied as two-component systems made up of a

powder and a liquid. These two components are mixed at an approximate ratio of 2:1 to

start a chemical reaction called polymerization, which forms the polymethylmethacrylate

(PMMA) cement.

• Powder components1:

◦ Copolymers beads based on the substance polymethylmethacrylate (PMMA); ◦ Initiator, such as benzoyl peroxide (BPO), which encourages the polymer and

monomer to polymerize at room temperature;

◦ Contrast agents such as zirconium dioxide (ZrO2) or barium sulphate (BaSO

4)

to make the bone cements radiopaque; and

◦ Antibiotics (eg, gentamicin, tobramycin).

• Liquid components2:

◦ A monomer, methylmethacrylate (MMA);

◦ Accelerator (N,N-Dimethyl para-toluidine) (DMPT);

◦ Stabilizers (or inhibitors) to prevent premature polymerization from exposure to

light or high temperature during storage; and

◦ Chlorophyll or articial pigment; sometimes added to cements for easier

visualization in case of revision.

There is a difference between PMMA bone cement and PMMA; however, many

healthcare personnel use the terms interchangeably and PMMA has become shorthandfor “bone cement”. However, PMMA is the substance from which copolymers are

derived for the powder component. When the copolymer powder is mixed with the MMA

monomer liquid, polymerization occurs and PMMA bone cement is created.


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POLYMERIZATIONPolymerization is a chemical reaction in which two or more small molecules combine to

form larger molecules that contain repeating structural units of the original molecules. In

the case of bone cement, the polymerization process starts when the copolymer powder

and monomer liquid meet, reacting together to produce an initiation reaction creating free

radicals that cause the polymerization of the monomer molecules. The original polymerbeads of the powder are bonded into a dough-like mass, which eventually hardens into

hard cement.

The polymerization process is an exothermic reaction, which means it produces

heat. With a maximum in vivo temperature of 40°C to 47°C, this thermal energy is

dissipated into the circulating blood, the prosthesis, and the surrounding tissue. Once

polymerization ends, the temperature decreases and the cement starts to shrink.

Phases and Times

The polymerization process can be divided into four different phases: mixing, waiting,

working, and setting. Package inserts that come with the products often refer to Dough

Time, Working Time, and Setting Time. Dough Time and Setting Time are measured from

the beginning of mixing; Working Time is the interval between Dough Time and Setting

Time. Both the Phases and corresponding Times are described below.

Mixing Phase

The mixing phase represents the time taken to fully integrate the powder and liquid. Asthe monomer starts to dissolve the polymer powder, the benzoyl peroxide is released into

the mixture. This release of the initiator benzoyl peroxide and the accelerator DMPT is

actually what causes the cement to begin the polymerization process. It is important for

the cement to be mixed homogeneously, thus minimizing the number of pores.

Waiting Phase/Dough Time

During this phase, typically lasting several minutes, the cement achieves a suitable

viscosity for handling (ie, can be handled without sticking to gloves). The cement is asticky dough for most of this phase.

Dough time is the time point measured from the beginning of mixing to the point when

the cement no longer sticks to surgical gloves. Under typical conditions (23°C-25°C,

65% relative humidity), dough time is 2-3 minutes after beginning of mixing for most bone

cements. Before this time point, after the components are well mixed, the bone cement

may be loaded into a syringe, cartridge, or injection gun for assisted application.3

Working Phase/Working TimeThe working phase is the period during which the cement can be manipulated and the

prosthesis can be inserted. The working phase results in an increase in viscosity and the

generation of heat from the cement. The implant must be implanted before the end of the

working phase.


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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 TimeDuring 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 inuenced 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 settingtimes 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 isrequired under these conditions. Water (or anything else) should never be added to bone

cement in an attempt to modify its curing behavior.

Why Don’t 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 signicantly 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. Somecement 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.


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• 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 PROPERTIESCement 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 inuence 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 cement’s 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 uid to deformation under shear forces andis commonly described as “thickness” of a uid. Viscosity also represents the resistance

to ow and is thought to be a measure of uid 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

rst, then later more rapidly. During the working phase, there are two requirements for

bone cement viscosity – it must be sufciently 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 sufciently high to withstand

the back-bleeding pressure, thus avoiding the risk of inclusion of blood into the cement

because this could signicantly 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


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Viscosity affects the following9:

• Mixing behaviour;

• Penetration into cancellous bone;

• Resistance against bleeding; and

• Insertion of the prosthesis.

Cement Temperature

To achieve optimal cement properties, it is important to adhere to the time schedules

indicating the correlation of temperature to handling time. These time schedules are

usually included in the manufacturer’s instructions for the bone cement.

Effects of Temperature:

• Temperature affects mixing time, delivery of the cement, prosthesis insertion, and

other aspects of the cementing process.

• Storage temperature will affect the cement times – not just the temperature at

which it is mixed.

• If cement has been stored in a cold environment, all the phases apart from the

mixing phase will be prolonged. High-viscosity cements are sometimes pre-chilledfor use with mixing systems for easier mixing and prolonged working phase. This

will also increase the setting time.

• If cement has been stored in a warmer environment, all phases will be shorter.

• Issues created by high temperatures:

◦ Integration of the powder and liquid can be difcult.

◦ Extrusion from a delivery gun can become difcult and may reduce delivery

pressures. ◦ Potential exists for cement to be inserted during the setting phase.

◦ Laminations can form between 3.5 and 6.5 minutes and reduce cement

strength by up to 54%.10

Mechanical Properties

The aim of a good cement mix is to produce bone cement that has the best mechanical

properties possible so that it can carry out its load transfer role successfully over the

lifetime of the implant. Once positioned within the hip or knee replacement, the cementaround the prosthesis is subjected to a series of physical forces that will have an effect

on the lifespan of the cement. These physical forces subject the cement to fatigue, creep,

and high stresses. The mechanical properties of the cement (eg, resistance to fatigue

and creep, and strength) should be enhanced as much as possible.


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Fatigue

Fatigue is the failure of a component after it is subjected to a large number of alternating,

uctuating loads; fatigue strength is a measure of a bone cement’s 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 besubjected. Clinical evidence has documented the existence of fatigue cracks in revision-

retrieved 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 37°C in the body.

Signicant 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 signicantly 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.


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TYPES OF BONE CEMENTCements 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 considerablyand 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 ofthe 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 signicant

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 wasn’t

until 2003 that the rst pre-blended bone cement containing an antibiotic (tobramycin)

became available for sale in the United States, specically for the treatment andreimplantation 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 scientic evidence for its use have expanded to primary arthroplasty

to minimize postoperative infection. Use of antibiotic cements for primary arthroplasty,


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however, remains controversial in the United States. The primary arguments proffered

against the routine use of antibiotic bone cement are lack of efcacy, adverse effects on

mechanical properties, increased costs, bacterial resistance, and systemic toxicity.25,26

However, there is signicant evidence to refute these arguments.27,28,29

The elution of antibiotics from PMMA bone cement can be affected by certain factorsincluding 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 signicantly 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 ciprooxacin.33,34,35

HISTORY OF BONE CEMENT MIXING SYSTEMS

Manual Mixing Until the 1980s, the composition and preparation of bone cement did not stray much from

the standards introduced in 1959 by Sir John Charnley, a British orthopaedic surgeon

who pioneered the hip replacement operation.36 Techniques for improving cement

strength were not extensively tried.

Original mixing techniques were either hand- or bag-mixing. The liquid was injected into

a powder bag and the two components were mixed by kneading. As mixing techniques

evolved, an open bowl was used to mix the cement. The liquid and powder were poured

into a plastic or stainless steel bowl and then mixed together with a spatula. A 1988

study by Linden of 46 samples of acrylic cement mixed by seven nurses found that a

manual mixing technique lacks reproducibility and produces cements with uncontrollable

porosity.37

Early in the use of open bowl mixing, exposure to the resulting noxious fumes created

serious safety concerns. A certain amount of porosity in the nal material remains

unavoidable with conventional hand mixing techniques today, due to the air introduced


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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 improvingbone cement properties. The results, however, were not convincing.38

Centrifugation

In this technique, cement was rst 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 signicantly

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

rening, it produced better results than centrifugation, which was soon thereafter retired

in favor of vacuum mixing43 and quickly became the preferred method of mixing. Forexample, 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 ofthese 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 nger packed. The proximal end waspacked with cement by pressing with the ngers 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.


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• Gun pressurization – Injection of the cement with a gun offers a mechanical

advantage that allows the surgeon to force more cement into the interstices of

the bone via higher pressurization. The pressurization tips of these devices allow

more cement to be forced tightly into the bone while also preventing overow.

SAFETY ISSUES RELATED TO BONE CEMENTThe components of PMMA bone cement (powder and liquid MMA monomer) are toxic

and highly ammable. 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 specic 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

ammable 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 uorescent 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 bonecement has been reported.46

Health Risks to Personnel 47

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 rangingfrom 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 time-

weighted 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 orlatex 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.


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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-glutamyl-

transpeptidase (GGTP) up to 10 days postoperation, thrombophlebitis, hemorrhage

and hematoma, pain and/or loss of function, loosening or displacement of the prosthesis, supercial 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 stula, 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 denition; 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 ve stages inthe surgical procedure; femoral reaming, acetabular or femoral cement implantation,

insertion of the prosthesis, or joint reduction.54


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RECOMMENDED PRACTICES FOR SAFE USE OF PMMA BONE CEMENTThe Association of periOperative Registered Nurses (AORN) Recommended Practices for

a Safe Environment of Care states that the potential hazards associated with the use of

methylmethacrylate in the practice setting should be identied and safe practices should be

established. Safe practices include the following measures55:

• Material safety data sheet (MSDS) information for methylmethacrylate must be

readily accessible to employees within the practice setting. This information includes

identication of hazards, precautions or special handling, signs and symptoms of

toxic exposure, and rst aid treatments for exposure. Methylmethacrylate should be

handled according to its MSDS.

• Methylmethacrylate fumes should be extracted from the environment; the fumes

should be exhausted to the outside air or absorbed through activated charcoal.

• Vacuum mixers with fume extraction should be used to decrease the fume levels to

which users are exposed.

• Eye protection should be worn to prevent contact with eyes. Methylmethacrylate

fumes may produce an adverse reaction with soft contact lenses, leading to irritation

and potentially, corneal ulceration. There is no documented evidence of problems

associated with hard contact lenses.

• The manufacturer’s recommendations should be followed for mixing and the required

personal protective equipment (PPE).

• A second pair of gloves should be worn when handling methylmethacrylate and should

be discarded after use. The manufacturer’s instructions should be followed regarding

the composition of the second pair of gloves. Methylmethacrylate may be absorbed

through the skin and may also penetrate many plastic and latex compounds, leading

to dermatitis. The liquid component of the cement should not come in contact with

gloves.

• A cement gun or mixing system, instead of hand mixing, should be used to decreasehandling of the product. The cement mixture should not be touched until it is the

consistency of dough.

• For methylmethacrylate spills:

◦ The area of the spill should be ventilated until the odor has dissipated;

◦ All sources of ignition should be removed;

◦ Appropriate PPE should be worn during the clean-up;

◦ The spill area should be isolated;◦ The liquid component should be covered with an activated charcoal absorbent; and

◦ The waste product should be disposed of in a hazardous waste container.

• Methylmethacrylate is a hazardous waste and should be disposed of according to

state, local, and federal regulations.


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SUMMARYPMMA 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 ammable. 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.


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GLOSSARYAccelerator A catalytic agent used to hasten a chemical

reaction.

Bone Cement Implantation A rare complex of sudden physiologic changesSyndrome (BCIS) characterized by hypoxia, hypotension or both

and/or unexpected loss of consciousness

occurring around the time of cementation,

prosthesis insertion, reduction of the joint or,

occasionally, limb tourniquet deation in a patient

undergoing cemented bone surgery. Symptoms

may occur within minutes of the use of PMMA

cement.

Compressive Strength The measure of bone cement’s durability during

weight bearing.

Copolymer A polymer derived from two or more monomers.

Creep The measure of bone cement’s reaction to a

combination of compressive and shear forces thatoccur during a variety of normal activities of daily

living over time.

Dough Time The time point measured from the beginning of

mixing to the point when the cement no longer

sticks to surgical gloves.

Exothermic Reaction A chemical reaction that produces heat.

Fatigue The failure of a component after it is subjected to

a large number of alternating, uctuating loads.

High-Viscosity Cements Cements that have a short waiting/sticky phase

and a long working phase. The viscosity remains

constant until the end of the working phase.

Laminations Faults or folds in the bone cement, which may be

caused by high temperature or “intrusions” such

as bone, water, blood, etc. Laminations create

potential areas of weakness in the cement mantle

where a failure can occur.


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Low-Viscosity Cements Cements that have a long waiting phase of about

3 minutes; the viscosity rapidly increases during

the working phase, making for a short working

phase.

Medium-Viscosity Cements Cements that have a long waiting phase of

approximately 3 minutes, but during the working

phase, the viscosity only increases slowly.

Methylmethacrylate (MMA) The liquid component of bone cement; MMA is a

monomer.

Mixing Phase The phase in which the monomer is thoroughlymixed throughout the powder bed and

polymerization is initiated.

Monomer A molecule of low molecular weight capable of

reacting with identical or different molecules of

low molecular weight to form a polymer. For bone

cement, the monomer MMA (a liquid) reacts with

the copolymers based on PMMA to form PMMAbone cement.

Parts per Million (ppm) “Parts per million” refers to a substance per

million parts of air; it is a measure of the

substance’s concentration of volume in air.

Permissible Exposure Limit (PEL) The permissible exposure limit of a hazardous

substance, which is enforceable by OSHA.

Polymerization The formation of a compound, usually of high

molecular weight, by the combination of several

low molecular weight compounds (eg, monomers,

copolymers).

Polymethylmethacrylate (PMMA) PMMA is a synthetic acrylic resin used as

the basis for PMMA bone cement. Bonecement consists of two primary components:

a powder consisting of copolymers based on

polymethylmethacrylate (PMMA), and a liquid

monomer, methylmethacrylate (MMA).


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Porosity The presence of entrapped air in bone cement.

High bone cement porosity compromises the

cement’s mechanical strength and decreases its

fatigue life. Centrifugation and vacuum mixing

methods, and pressurized cement application can

decrease the porosity of bone cement.

Setting Phase The nal curing state of the polymerization

process of bone cement; the implant should

already be in its nal position.

Setting Time Time point 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.

Stress The load applied to a material over a given area.

Viscosity A measure of the resistance of a uid todeformation under shear forces and is commonly

described as “thickness” of a uid. The

viscosity of bone cement affects its handling

characteristics, handling time, and penetration of

the cement into the cancellous bone.

Waiting Phase The phase of the polymerization process where

bone cement begins to swell and viscosity begins

to increase, creating a sticky dough. By the end

of the waiting phase, the doughy cement will not

stick to surgical gloves.

Working Phase The time during the polymerization process at

which bone cement is ready for application; the

implant must be implanted before the end of the

working phase.

Working Time The interval between the dough and setting times,

typically 5-8 minutes.


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http://www.bonecement.com/cementing-techniques/mixingdelivery/historyhttp://www.bonecement.com/cementing-techniques/mixingdelivery/historyhttp://www.depuy.com/sites/default/files/products/files/DO_Unmedicated_Bone_Cements_MSDS.pdfhttp://www.depuy.com/sites/default/files/products/files/DO_Unmedicated_Bone_Cements_MSDS.pdfhttp://www.depuy.com/sites/default/files/products/files/DO_Unmedicated_Bone_Cements_MSDS.pdfhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttps://www.osha.gov/dts/chemicalsampling/data/CH_254400.htmlhttps://www.osha.gov/dts/chemicalsampling/data/CH_254400.htmlhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttps://www.osha.gov/dts/chemicalsampling/data/CH_254400.htmlhttps://www.osha.gov/dts/chemicalsampling/data/CH_254400.htmlhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.fda.gov/ohrms/dockets/98fr/071702c.htmhttp://www.depuy.com/sites/default/files/products/files/DO_Unmedicated_Bone_Cements_MSDS.pdfhttp://www.depuy.com/sites/default/files/products/files/DO_Unmedicated_Bone_Cements_MSDS.pdfhttp://www.depuy.com/sites/default/files/products/files/DO_Unmedicated_Bone_Cements_MSDS.pdfhttp://www.bonecement.com/cementing-techniques/mixingdelivery/historyhttp://www.bonecement.com/cementing-techniques/mixingdelivery/history


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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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Principles of Bone Cement and the Process of Bone Cement Mixing

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