Effect of two variables on the fatigue performance of acrylic bone cement: mixing method and viscosity

The goal of the present work was to establish the relative influence of one exogenous variable versus one endogenous variable on the fully-reversed tension-compression fatigue performance of bone cement. The method used to mix the cement constituents was the exogenous variable, while the viscosity of the mixed cement dough was the endogenous variable. Two commercial cement formulations (Palacos R and Osteopal) and two cement mixing methods (hand mixing and vacuum mixing) were used. It was found that for a given mixing method, cement viscosity exerts a marginal influence on fatigue performance. On the other hand, for a given cement formulation, vacuum mixing led to a statistically significant improvement in fatigue performance. The present results demonstrate the superior influence of mixing method over cement viscosity.     

Relative roles of cement molecular weight and mixing method on the fatigue performance of acrylic bone cement: Simplex P versus Osteopal

The weight-average molecular weight (MW(w)) of a cement and the method used to mix its powder and liquid monomer constituents have been identified in the literature as key variables that affect mechanical properties of the fully polymerized cement that are relevant to its performance as a grouting agent in cemented arthroplasties. The goal of the present work was to identify which of these two variables exerts the greater effect in the case of fully reversed tension-compression fatigue performance. A judicious choice of cement brands, Surgical Simplex P and Osteopal, and the use of hand versus vacuum mixing, permitted this identification to be achieved. Three key observations were made in this work. First, for a given cement, the fatigue performance of vacuum-mixed specimens is far superior to that of hand-mixed ones, which may be a consequence of the substantially lower percentage areal porosity of the former specimens. Second, regardless of the mixing method, the fatigue performance of Osteopal outstrips that of Simplex P, a result that is attributed to the much higher MW(w) of the former cement. Third, hand-mixed Osteopal outperforms vacuum-mixed Simplex P (especially at low alternating stress levels), indicating that MW(w) of a bone cement is more influential than mixing method on its fatigue performance.     

Effect of test frequency on the in vitro fatigue life of acrylic bone cement

The goal of the present work was to test the hypothesis that test frequency, f, does not have a statistically significant effect on the in vitro fatigue life of an acrylic bone cement. Uniaxial constant-amplitude tension-compression fatigue tests were conducted on 12 sets of cements, covering three formulations with three very different viscosities, two different methods of mixing the cement constituents, and two values of f (1 and 10 Hz). The test results (number of fatigue stress cycles, N(f)) were analyzed using the linearized form of the three-parameter Weibull equation, allowing the values of the Weibull mean (N(WM)) to be determined for each set. Statistical analysis of the lnN(f) data, together with an examination of the N(WM) estimates, showed support for the hypothesis over the range of f used. The principal use and explanation of the present finding are presented.     

Effect of fabrication pressure on the fatigue performance of Cemex XL acrylic bone cement

During a cemented arthroplasty, the prepared polymerizing dough of acrylic bone cement is subjected to pressurization in a number of ways; first, during delivery into the freshly prepared bone bed, second, during packing in that bed (either digitally or with the aid of a mechanical device), and, third, during the insertion of the prosthesis. Only a few studies have reported on the influence of the level of pressurization experienced during these events (which, depending on the cementing technique used, has been put at between 8 and 273 kPa) on various properties of the cement. That was the focus of the present study, in which the fully reversed tension-compression (+/-15 MPa; 5 Hz) fatigue lives (expressed as number of cycles to fracture, N(f)) of rectangular cross-sectioned "dog-bone" specimens (Type V, per ASTM D 638) fabricated from Cemex XL cement, at pressure applied continuously to the cement dough during curing in the specimen mold, p=75,150, and 300 kPa, were determined. The N(f) results were analyzed using the linearized transformation of the three-parameter Weibull relationship to obtain estimates of the Weibull mean, N(WM), which was taken to be the index of fatigue performance of the specimen set. Over the range of p studied, N(WM) increased as p increased (for example, from 329,118 cycles when p was 75 kPa to 388,496 cycles when p was 300 kPa); however, the increase was not significant over any pair of p increment steps (Mann-Whitney U-test; alpha<0.05).     

Influence of mixing techniques on the physical properties of acrylic bone cement

Palacos R bone cement was prepared using three commercially available mixing techniques, first generation, second generation and third generation, to determine the mechanical properties and porosity contents of the bone cement. The compressive strengths, bending strengths and flexural moduli were expressed as a function of void content. The volume of pores within the cement structure was found to be a contributing factor to the physical properties of acrylic bone cement. The lower the volume of voids in the cement the better the compressive and flexural properties, hence stronger bone cement. It was found that the best results were obtained from cement that had been mixed using the Mitab Optivac or Summit HiVac Syringe systems at a reduced pressure level of between -72 and -86 kPa below atmospheric pressure, resulting in cement of porosity 1.44-3.17%; compressive strength 74-81 MPa; flexural modulus 2.54-2.60 GPa; and flexural strength 65-73 MPa.     

Effect of test specimen cross-sectional shape on the in vitro fatigue life of acrylic bone cement

Constant-amplitude uniaxial tension-compression fatigue tests were conducted on specimens fabricated from 12 sets of acrylic bone cements, covering cement formulations with three different viscosities (so-called "high-", "medium-" and "low-viscosity" varieties), two different methods of mixing the cement constituents (so-called "hand-" and "vacuum-mixed" methods) and two test specimen shapes (rectangular-cross-sectioned or "flat" and circular-cross-sectioned or "round"). The test results-namely, the number of fatigue stress cycles, N(f)-were analyzed using the linearized transformation of the three-parameter Weibull relationship, allowing the values of the Weibull mean, N(WM), to be determined for each set. Values ranged from 14,300 to 1,284,331 for the round specimen sets and from 2898 to 72,960 for the flat specimen sets. Statistical analysis of the ln N(f) data, together with an examination of the N(WM) values, showed that, for any combination of cement formulation and mixing method, round specimens had significantly longer fatigue lives compared to flat ones. These results are explained in terms of two factors. The first is the smaller surface area of the waisted zone in the round specimens compared to that in the flat specimens (nominal value of 157mm(2) versus nominal value of 185mm(2)), leading to the possibility of fewer crack initiation sites on the round specimens compared to the flat ones. Secondly, it is postulated that the crystallinity of the round specimens was higher than that of the flat ones, a consequence of the significantly lower measured residual liquid monomer contents of the former compared to the latter (3.40+/-1.28wt%/wt compared to 3.81+/-1.48wt%/wt). The significance of the present finding is that it indicates that, for a set of bone cement formulation and experimental conditions, discriminating fatigue test results are more likely to be obtained if flat, rather than round, test specimens are used.     

Quantitative analysis of the effect of porosity on the fatigue strength of bone cement

This paper reports on the effects of porosity and its distribution on the fatigue strength of bone cement. Hand-mixed (HM) and vacuum-mixed (VM) bone cement samples were fatigue tested to failure. The point of failure commonly coincided with large single pores (in the VM materials) and multiple pores in clusters (in the HM material). The effect of pores was analysed using the Theory of Critical Distances (TCD), a theory previously developed to explain the effect of notches and other stress concentrations on fatigue and fracture. Clusters of pores were analysed by developing a criterion to decide whether local cracking would act to link pores together, forming a single stress concentration of more complex shape. This approach enabled us to predict the high-cycle fatigue strength of samples containing clusters of pores, with good accuracy (errors less than 13%). We then used the analysis to develop general rules for the effect of pore size and proximity on fatigue strength. For example, we showed that a single pore of 2mm diameter or more would cause a significant decrease in the fatigue strength (compared to that of pore-free material); however, two pores of only 1mm diameter in close proximity would be equally damaging. This demonstrates the importance not only of pore size but also of pore density and distribution. However, pores do have beneficial effects such as improved drug dispersion, bone ingrowth and crack tip blunting. Therefore, given the findings from this study, a possible step forward in the development of surgical bone cements may involve a compromise in which relatively small pores are evenly distributed throughout the material.     

Effect of porosity and environment on the mechanical behavior of acrylic bone cement modified with acrylonitrile-butadiene-styrene particles: I. Fracture toughness.

The elastomeric copolymer acrylonitrile-butadiene-styrene (ABS) was added to a conventional acrylic bone cement matrix. The results obtained show that although strength and stiffness decreased with an increasing second phase volume fraction, ductility and toughness both increased. The crack propagation became stable for specimens containing over a 5% volume fraction of the second phase. The fracture toughness increased up to 60% when the amount of ABS reached 20% (v/v). For larger amounts linear elastic fracture mechanics techniques could not be used properly. The effects of porosity and environmental conditions on the mechanical behavior were also studied. The mechanisms that control the fracture process were investigated by means of scanning electron microscopy.     

Effect of lithotriptor treatment on the fracture toughness of acrylic bone cement.

Extracorporeal shock wave lithotripsy (ESWL) has now been established as an efficacious non-invasive modality for the management of renal calculi and has shown promise for management of other types of stone, as well. Following on from these successes, ESWL has recently been proposed for use in the preliminary stages of revision of cemented total hip joint replacements as a means of breaking up the cement mantle. It is useful, therefore, to examine the effect of shock waves on pertinent mechanical properties of the cement. This study utilizes the chevron-notch short-rod specimen and a commercially available test system to obtain the values of one such property, namely fracture toughness, of Palacos Radiopaque bone cement before and after treatment with shock waves delivered from a lithotriptor. The fracture toughness drops by about 14% following the shock wave treatment, thus confirming the possibility that ESWL can be used, as indicated earlier, in revision arthroplasty.     

The relationship between stress, porosity, and nonlinear damage accumulation in acrylic bone cement.

The long-term survival of cemented hip replacements depends on the ability of the cemented fixation to resist fatigue damage. Damage has been assumed to accumulate linearly (Miner's law) even though it is unlikely to be the case in such a porous brittle material. This study addresses the nonlinear stress-dependent nature of fatigue damage accumulation in acrylic bone cement. Specimens were subjected to a zero-to-tension fatigue load in water at 37 degrees C. A total of 15 specimens were tested, i.e., five specimens at each of three stress levels. The specimens were cyclically loaded to a certain fraction of their fatigue lives and the amount of microcracking present at that time was quantified by counting each crack and measuring its length. This procedure was repeated until the specimen failed. A total of 801 cracks formed in the 15 specimens. All cracks were found to initiate at pores. Crack propagation directions were distributed normally about the direction perpendicular to the applied load at the lower stress levels, but at higher stress, the distribution tended to be broader. At higher stresses, more cracks were produced per pore. The damage accumulation process in acrylic bone cement was found to be nonlinear with the degree of nonlinearity increasing with stress. Furthermore, great variability was found which was attributed to the differences in porosity between specimens. A power law equation is given which describes the predicted relationship between damage accumulation and number of loading cycles as a function of the stress level.     

Effect of porosity and environment on the mechanical behavior of acrylic bone cement modified with acrylonitrile-butadiene-styrene particles: part II. Fatigue crack propagation.

The aim of this study was to investigate the effect of adding an elastomeric second phase, acrylonitrile-butadiene-styrene, on the fatigue crack propagation behavior of poly(methyl methacrylate) bone cement. Moreover, the influence of porosity and environmental conditions was studied. When comparing the plain cement to the modified cement, a decrease in the crack propagation rate was observed at between 1 and 2 orders of magnitude. The storage in a physiological environment (saline solution at 37 degrees C) also caused a decrease in the crack propagation rate of about 2 orders of magnitude for the plain and modified cement prepared in air or under a vacuum. Porosity did not have any noticeable effect on the fatigue crack propagation behavior of the cement.     

A fractographic investigation of PMMA bone cement focusing on the relationship between porosity reduction and increased fatigue life.

Fracture surfaces of both monotonic and fatigue loaded bone cement samples were examined to investigate the fractographic characteristics of PMMA. Classic cleavage step river patterns were observed on all monotonically loaded samples, running downstream in the direction of crack propagation. All fatigue cracks initiated at internal pores and the direction of crack propagation of many cracks was discernible. Porosity, pore size, and pore size distribution were found to affect the crack initiation and fatigue behavior of bone cement. Statistical analysis revealed a strong negative correlation between two-dimensional porosity present on the fracture surfaces and the cycles to failure. The fractographic observations of these fatigue samples elucidate one reason why porosity reduction by centrifugation or vacuum mixing increases the fatigue life of PMMA bone cement.     

Investigation of fatigue crack growth in acrylic bone cement using the acoustic emission technique

Failure of the bone cement mantle has been implicated in the loosening process of cemented hip stems. Current methods of investigating degradation of the cement mantle in vitro often require sectioning of the sample to confirm failure paths. The present research investigates acoustic emission as a passive experimental method for the assessment of bone cement failure. Damage in bone cement was monitored during four point bending fatigue tests through an analysis of the peak amplitude, duration, rise time (RT) and energy of the events emitted from the damage sections. A difference in AE trends was observed during failure for specimens aged and tested in (i) air and (ii) Ringer's solution at 37 degrees C. It was noted that the acoustic behaviour varied according to applied load level; events of higher duration and RT were emitted during fatigue at lower stresses. A good correlation was observed between crack location and source of acoustic emission, and the nature of the acoustic parameters that were most suited to bone cement failure characterisation was identified. The methodology employed in this study could potentially be used as a pre-clinical assessment tool for the integrity of cemented load bearing implants.     

Degree of polymerization of acrylic bone cement.

Self-curing powder-liquid admixed acrylic systems are used for internal fixation fo total hip and total knee prostheses. Gel permeation chromatography revealed that the polymer chain length distributions of set cements were basically unaffected by their curing pressures. However, a decrease of approximately 11% in porosity coupled with a measured increase in mechanical strengths could be induced through the use of high curing pressures well beyond those attainable by the surgeon in the current arthroplasties. The conclusion of the investigation was that, to improve such cements, attention should be focused on elimination of porosity rather than attempting to produce higher degree of polymerization.     

Estimation of the minimum number of test specimens for fatigue testing of acrylic bone cement

In the literature on fatigue testing of acrylic bone cements, data sets of various sizes have been used in different test series for the same cement formulation. There are two important consequences of this situation. First, it means that some test series last much longer than others, with all the implications for the cost of testing. Second, it makes drawing conclusions about the fatigue performance of a cement, based on the results of different literature series, a problematic issue. Clearly then, a recommendation as to what should be the minimum number of test specimens to use that would allow for confidence in the results of the statistical treatment of the test results (Gmin) would be desirable. In the present work, a method that could be used to culminate in such a recommendation is described. This method involves (i) obtaining experimental fatigue test results and (ii) analyzing those results using the Weibull probability distribution function and other statistical methods. This methodology is illustrated using fatigue life results obtained from uniaxial tension-compression fatigue tests on specimens fabricated from the polymerizing dough of one commercially available acrylic bone cement. For a tolerable error of 5%, we estimated Gmin to be either 7 (if the fatigue life results are treated using the two-parameter Weibull distribution function) or 11 (if the fatigue life results are treated using the three-parameter Weibull distribution function). To be on the conservative side, we therefore recommend that Gmin be 11. Three key limitations of the methodology presented here are discussed.     

Effects of the initial temperature of acrylic bone cement liquid monomer on the properties of the stem-cement interface and cement polymerization

It has been shown that preheating the femoral stem prior to insertion minimizes interfacial porosity at the stem-cement interface. In this study, the effects of methylmethacrylate monomer temperature prior to mixing on the properties of stem-cement interface and cement polymerization were evaluated for 4 degrees C, room temperature, and 37 degrees C using a test model and cementing techniques that simulated a clinical situation. The nature and extent of interfacial porosity of stem-cement interface was quantified, the static shear strength of the stem-cement interface determined, and the time and temperature of polymerization at the cement-bone interface were measured. Compared to RT monomer, preheating monomer to 37 degrees C produced higher polymerization temperatures and greater initial interfacial shear strength with an unchanged amount of interfacial porosity. Precooling monomer to 4 degrees C produced lower polymerization temperatures and decreased initial interfacial shear strength, with the amount of interfacial porosity unchanged compared to the RT group. Although clinical techniques of preheating or precooling bone cement have some effects on the properties of the stem-cement interface and cement polymerization, they do not appear to enhance implant fixation.     

Effect of loading rate on the apparent fracture toughness of acrylic bone cement

In this study, a determination is made of the effect of loading rate, v (0.1 mm min(-1) versus 1.0 mm min(-1) versus 10 mm min(-1)) on the value of the plane strain fracture toughness, K(Ic), of three commercial formulations of acrylic bone cement (Osteopal), CMW3, and Copal), that are characterized as "low-", "medium-", and "high-" viscosity brands, respectively). For all formulations, K(Ic) increases with increase in v. However, while this trend is statistically significant for CMW3 and Copal, this is not so for Osteopal. The CMW3 and Copal results are explained in terms of changes of the molecular relaxation transitions in the cement and the thermal state at the crack tip of the test specimen. Two implications of the findings are discussed. In the case of Osteopal, a recommendation for further study is made.     

Slow crack growth in acrylic bone cement.

Slow crack growth in Perspex acrylic sheet (PMMA) and Simplex acrylic bone cement in air and water has been studied from a fracture mechanics viewpoint. It has been found that the crack velocity, V, for each material depends upon the intensification of stress at the tip of the crack. Experimental measurements have been made of V as a function of the stress intensity factor, K, at the crack tip, and a derived V, K relationship has been used to predict the times-to-failure of components made from PMMA and Simplex cement. Direct measurements of time-to-failure for PMMA have shown that the predicted values give a conservative estimate of the structural lifetime of the material.     

A proposed specification for acrylic bone cement.

A proposed specification covering handling characteristics and physical and chemical properties of bone cement composed primarily of methyl methacrylate has been prepared on the basis of data from the authors' studies and from various other sources. Under handling characteristics, requirements included relate to dough, handling and setting time, proper plasticity for insertion and temperature rise on setting. Mechanical properties specified include compressive strength and indentation and recovery characteristics. Maximum limits are proposed for water sorption and solubility. Suggested packaging requirements are also included.     

The influence of the viscosity classification of an acrylic bone cement on its in vitro fatigue performance

The goal of the present work was to investigate the influence of the viscosity classification of an acrylic bone cement on its in vitro fatigue performance, as determined in fully-reversed tension-compression (+/-15 MPa) fatigue tests. The test matrix comprised six commercially available bone cements [Orthoset1, (OS1), Orthoset(R)3 (OS3), CemexRX (CRX), Cemex XL (CXL), Palacos R (PR) and Osteopal (OP)], two methods of mixing the cement constituents (hand-mixing and vacuum-mixing), two methods of fabricating the test specimens (direct molding and molding followed by machining), two specimen cross-sectional shapes (rectangular or "flat" and circular or "round"), and four test frequencies (1, 2, 5, and 10 Hz). In total, 185 specimens, distributed among 20 sets, were tested. The test results (number of fatigue stress cycles, N_f) were processed using the linearized transformation of the three-parameter Weibull distribution, whence estimates of the Weibull mean, N_[WM], were obtained. Statistical analysis of the ln N_f results (Mann-Whitney test; alpha<0.05) and a comparison of the N_[WM] estimates for specimen sets in which the formulations have essentially the same composition but different viscosity classification (namely, OS1 versus OS3, CRX versus CXL, and PR versus OP) showed that, in the majority of the comparisons carried out, the viscosity classification of a bone cement does not exert a significant influence on its in vitro fatigue performance.