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.     

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.     

Fatigue of acrylic bone cement--effect of frequency and environment

This study was conducted to investigate some fundamental fatigue testing variables as they apply to the response characteristics of acrylic bone cement. Cyclic loading under load control was conducted at frequencies of 1, 2, 5, 10, and 20 Hz in air at room temperature. At a tensile stress range of 0.3-20.0 MPa the fatigue life increased linearly with logarithmic frequency. The effect of conditioning and testing in saline at both room temperature and 37 degrees C at similar stress levels and a frequency of 10 Hz were also examined. When compared to dry testing at room temperature, testing in saline at 37 degrees C resulted in a reduction in fatigue life while testing in saline at room temperature produced an increase in fatigue life. Of a number of statistical distributions considered, the Weibull was found to be the most appropriate in documenting the findings of this investigation. A companion fractographic investigation of the failure surfaces demonstrated distinct regions of crack growth and fast fracture.     

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.     

Statistical distribution of the fatigue strength of porous bone cement

This paper reports on the damaging effects of different percentage porosities on the fatigue life of acrylic bone cement as used in the fixation of orthopaedic implants. Both hand-mixed (HM) and vacuum-mixed (VM) specimens containing different levels of porosity were fatigue tested to failure. A negative correlation between porosity level and fatigue life was demonstrated for both techniques. Considerable scatter was present in the data. Using the pore size distributions for HM and VM cement virtual HM and VM specimens were created containing various levels of porosity. Incorporating the effect of pore size and pore clustering quantified previously using the theory of critical distances a fatigue life prediction could be obtained for the virtual specimens. The virtual data agreed strongly with the experimental findings, predicting the correlation and more significantly the scatter in the experimental results. Using the virtual porosity failure model, it was demonstrated that given a constant porosity the fatigue life can vary by over an order of magnitude in both HM and VM cement. This suggests that not only porosity level but pore size distribution is extremely important in controlling the fatigue life of bone cement. It was verified that pore clustering and pore size are the major contributors to failure in HM and VM cement respectively. Furthermore, given the beneficial effects of porosity it has been proposed that an even distribution of small pores would provide an optimal bone cement mantle. Using the virtual model, it was determined that neither technique was capable of achieving such a distribution indicating a need for a new more reliable technique. The TCD based virtual porosity failure model should prove to be a powerful tool in the design of such a technique.     

Fatigue and fracture toughness of acrylic bone cements modified with long-chain amine activators

The composition of acrylic bone cement has been identified as one of the important parameters affecting its mechanical properties and may, in turn, ultimately influence the longevity of a cemented arthroplasty. Our aim in this study was to determine the influence of change of one compositional variable, the activator, on the fatigue performance and fracture toughness of specimens of the fully cured cement. To that end, three sets of cements were prepared, containing either the conventional activator, 4-N,N dimethyl p-toluidine (DMPT), or novel ones that are tertiary amines based on long-chain fatty acids, that is, 4-N,N dimethylaminobenzyl oleate (DMAO) and 4-N,N dimethylaminobenzyl laurate (DMAL). In the fatigue tests, the specimens were subjected to tension-tension loading, and the results (number of cycles to failure, Nf) were analyzed using the linearized form of the three-parameter Weibull equation. The fracture toughness (KIc) tests were conducted with rectangular compact tension specimens. All fracture surfaces were subsequently examined with scanning electron microscopy. We found that the Weibull mean fatigue lives for specimens fabricated using the DMPT, DMAL, and DMAO containing cements were 272,823, 453,551, and 583,396 cycles, respectively. The corresponding values for KIc were 1.94 +/- 0.05, 2.06 +/- 0.09, and 2.00 +/- 0.07 MPa radical m, respectively. Statistical analyses showed that for both the DMAL- and DMAO-containing cements, the mean values of Nf were significantly higher compared to the corresponding value for the DMPT-containing cement (Mann-Whitney test; alpha < 0.10). This result is attributed to the higher molecular weights of the former cements compared to the latter. The same trend was found for the mean KIc values (Mann-Whitney test; alpha < 0.05), with the trend being explained in terms of the differences seen in the crack morphologies. These results thus demonstrate that these novel amines are viable alternatives to DMPT for incorporation into acrylic bone cement formulations in the future.     

A simple multi-specimen apparatus for fixed stress fatigue testing.

To cope with the time-consuming characteristics of fatigue tests, a multi-specimen fatigue testing apparatus, which could test 10 specimens at a time, was designed, constructed, and tested. The specimens are fixed around a rotating axis, and the required stresses are applied by weights attached on the other end of each specimen. The test mode can be categorized as a stress-controlled flexural fatigue test. Its performance was tested by comparing it with a commercial three-point bending fatigue testing apparatus. The stress versus number of cycles to failure curves of poly(methylmethacrylate) (PMMA), which were obtained from both fatigue testing equipment, showed results that were similar to each other. The fatigue test results of acrylic bone cement in a fixed-stress mode also showed good agreement between the data obtained from the new apparatus and the commercial apparatus. The test results seem quite reliable and show feasibility of significantly reducing the overall test periods. It may be valuable, especially for the fatigue tests, which must be done with a low frequency and a low applied stress level such as a fatigue test of bone cements.     

Effect of mixing method and storage temperature of cement constituents on the fatigue and porosity of acrylic bone cement.

The influence of the storage temperature of the cement constituents prior to mixing (21 vs. 4 degrees C) and the mixing method (hand mixing vs. vacuum mixing) on the uniaxial tension-compression fatigue performance and porosity of Palacos R acrylic bone cement was studied. The fatigue results were analyzed using the three-parameter Weibull equation. The fatigue performance was expressed as an index I, which was defined as the product of the Weibull characteristic fatigue life and the square root of the Weibull slope. Statistical analyses of these results show that although the mixing method (for a given storage temperature) exerts a significant influence on the fatigue performance and areal porosity, the effect of storage temperature (for a given mixing method) on either of these parameters is not significant.     

Augmentation of acrylic bone cement with multiwall carbon nanotubes

Acrylic bone cement, based on polymethylmethacrylate (PMMA), is a proven polymer having important applications in medicine and dentistry, but this polymer continues to have less than ideal resistance to mechanical fatigue and impact. A variety of materials have been added to bone cement to augment its mechanical strength, but none of these augmentative materials has proven successful. Carbon nanotubes, a new hollow multiwalled tubular material 10-40 nm in diameter, 10-100 microm long, and 50-100 times the strength of steel at 1/6 the weight, have emerged as a viable augmentation candidate because of their large surface area to volume ratio. The objective of this study was to determine if the addition of multiwall carbon nanotubes to bone cement can alter its static or dynamic mechanical properties. Bar-shaped specimens made from six different (0-10% by weight) concentrations of multiwall carbon nanotubes were tested to failure in quasi-static 3-point bending and in 4-point bending fatigue (5 Hz). Analyses of variance and the 3-Parameter Weibull model were used to analyze the material performance data. The 2 wt % MWNT concentration enhanced flexural strength by 12.8% (p=0.003) and produced a 13.1% enhancement in yield stress (p=0.002). Bending modulus increased slightly with the smaller (<5 wt % MWNT) concentrations, but increased 24.1% (p<0.001) in response to the 10 wt % loading. While the 2 wt % loading produced slightly improved quasi-static test results, it was associated with clearly superior fatigue performance (3.3x increase in the Weibull mean fatigue life). Weibull minimum fatigue life (No), Weibull modulus (alpha), and characteristic fatigue life (beta) for bone cement augmented with carbon nanotubes were enhanced versus that observed in the control group. These data unambiguously showed that the bone cement-MWNT polymer system has an enhanced fatigue life compared to "control" bone cement (no added nanotubes). It is concluded that specific multiwall carbon nanotube loadings can favorably improve the mechanical performance of bone cement.     

Comparison of two methods of fatigue testing bone cement

Two different methods have been used to fatigue test four bone cements. Each method has been used previously, but the results have not been compared. The ISO 527-based method tests a minimum of 10 samples over a single stress range in tension only and uses Weibull analysis to calculate the median number of cycles to failure and the Weibull modulus. The ASTM F2118 test regime uses fewer specimens at various stress levels tested in fully reversed tension–compression, and generates a stress vs. number of cycles to failure (S–N) or Wöhler curve. Data from specimens with pores greater than 1 mm across is rejected. The ISO 527-based test while quicker to perform, provides only tensile fatigue data, but the material tested includes pores, thus the cement is closer to cement in clinical application. The ASTM regime uses tension and compression loading and multiple stress levels, thus is closer to physiological loading, but excludes specimens with defects obviously greater than 1 mm, so is less representative of cement in vivo. The fatigue lives between the cements were up to a factor 15 different for the single stress level tension only tests, while they were only a factor of 2 different in the fully reversed tension–compression testing. The ISO 527-based results are more sensitive to surface flaws, thus the differences found using ASTM F2118 are more indicative of differences in the fatigue lives. However, ISO 527-based tests are quicker, so are useful for initial screening.     

A new, reliable, and simple-to-use method for the analysis of a population of values of a random variable using the Weibull probability distribution: application to acrylic bone cement fatigue results

In cases where the Weibull probability distribution is being investigated as a possible fit to experimentally obtained results of a random variable (V), there is, currently, no accurate and reliable but simple-to-use method available for simultaneously (a) establishing if the fit is of the two- or three-parameter variant of the distribution, and/or (b) estimating the minimum value of the variable (V(0)), in cases where the three-parameter variant is shown to be applicable. In the present work, the details of such a method -- which uses a simple nonlinear regression analysis -- are presented, together with results of its use when applied to 4 sets of number-of-cycles-to-fracture results from fatigue tests, performed in our laboratory, using specimens fabricated from 3 different acrylic bone cement formulations. The key result of the method is that the two- or three-parameter variant of the probability distribution is applicable if the estimate of V(0) obtained is less than or greater than zero, respectively.     

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).     

Tensile characteristics of ten commercial acrylic bone cements

The mechanical properties of acrylic bone cement, used in orthopedic surgery, are very influential in determining successful long-term stability of a prosthesis. A large number of commercial formulations are available, differing in chemical composition and physical properties of both powder and monomer constituents. In this study, the static and dynamic tensile characteristics of a number of the most commonly used bone cements (Palacos R, Simplex P, CMW 1 & 3, Sulfix-60, Zimmer Dough), along with some newer formulations (Endurance, Duracem 3, Osteobondtrade mark and Boneloc), have been investigated under the same testing regimes. Testing was performed in air at room temperature. Significant differences in both static and fatigue properties were found between the various bone cements. Tensile tests revealed that Palacos R, Sulfix-60, and Simplex P had the highest values of ultimate tensile strength, closely followed by CMW 3, while Zimmer Dough cement had the lowest strength. Fatigue testing was performed under stress control, using sinusoidal loading in tension-tension, with an upper stress level of 22MPa. The two outstanding cements when tested in these cyclic conditions were Simplex P and Palacos R, with the highest values of Weibull median cycles to failure. Boneloc bone cement demonstrated the lowest cycles to failure. While the testing regimes were not designed to replicate exact conditions experienced by the bone cement mantle in vivo, there was a correlation between these results and clinical outcome.     

Toward standardization of methods of determination of fracture properties of acrylic bone cement and statistical analysis of test results

A succinct critical review of the literature on the fatigue, fatigue crack propagation, and fracture toughness (herein collectively termed "fracture properties") of acrylic bone cement is presented, whereby it is pointed out that a plethora of test conditions have been used. This situation precludes meaningful interstudy comparisons and mitigates against a definitive delineation of the effect of a named variable on a specified fracture property. A case for standardization of test conditions is thus made, culminating in the presentation of a recommended set of such conditions. In addition, it is shown that many literature parametric studies employed inappropriate statistical methods for performing pairwise comparisons, and all these studies have not addressed the issue of possible interactions between the parameters being investigated. A methodology for addressing these deficiencies is presented in the present report, and its use is illustrated with a set of notional fatigue test results.     

The relationship between porosity and fatigue characteristics of bone cements

In this study, the fatigue strengths of acrylic cement prepared by various commercially available reduced pressure mixing systems were compared with the fatigue strength of cement mixed by hand (control) under atmospheric conditions. The following observations were made from this investigation. The mean fatigue strength of reduced pressure mixed acrylic bone cement is double that of cement mixed by hand using an open bowl, 11,354+/-6,441 cycles to failure for reduced pressure mixing in comparison with 5,938+/-3,199 cycles for mixing under atmospheric conditions. However, the variability in mean fatigue strengths of reduced pressure mixed bone cement is greater for some mixing devices. The variation in fatigue strengths for the different mixing techniques is explained by the different porosity distributions. The design of the reduced pressure mixing system and the technique employed during mixing strongly contribute to the porosity distribution within the acrylic bone cement. The level of reduced pressure applied during cement mixing has an effect on the fatigue strength of bone cement, but the mixing mechanism is significantly more influential.     

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.     

Static and fatigue mechanical behavior of bone cement with elevated barium sulfate content for treatment of vertebral compression fractures

The use of bone cement to treat vertebral compression fractures in a percutaneous manner requires placement of the cement under fluoroscopic image guidance. To enhance visualization of the flow during injection and to monitor and prevent leakage beyond the confines of the vertebral body, the orthopedic community has described increasing the amount of radiopacifier in the bone cement. In this study, static tensile and compressive testing, as well as fully reversed fatigue testing, was performed on three PMMA-based bone cements. Cements tested were SimplexP with 10% barium sulfate (Stryker Orthopedics, Mahwah, NJ) which served as a control; SimplexP with 36% barium sulfate prepared according to the clinical recommendation of Theodorou et al.; and KyphX HV-R with 30% barium sulfate (Kyphon Inc., Sunnyvale, CA). Static tensile and compressive testing was performed in accordance with ASTM F451-99a. Fatigue testing was conducted in accordance with ASTM F2118-01a under fully reversed, +/-10-, +/-15-, and +/-20-MPa stress ranges. Survival analysis was performed using three-parameter Weibull modeling techniques. KyphX HV-R was found to have comparable static mechanical properties and significantly greater fatigue life than either of the two control materials evaluated in the present study. The static tensile and compressive strengths for all three PMMA-based bone cements were found to be an order of magnitude greater than the expected stress levels within a treated vertebral body. The static and fatigue testing data collected in this study indicate that bone cement can be designed with barium sulfate levels sufficiently high to permit fluoroscopic visualization while retaining the overall mechanical profile of a conventional bone cement under typical in vivo loading conditions.     

Fatigue testing and performance of acrylic bone-cement materials: state-of-the-art review

Over the past three decades or so, a very large volume of literature has been generated on the impact of an assortment of variables on the fatigue lifetimes of a large number of acrylic bone-cement formulations. In the present article, this literature is examined critically to reveal areas of agreement, areas of disagreement, as well as a welter of underexplored and unexplored topics. For example, there is unanimity of support for the notion that an increase in the molecular weight of the powder constituents or the fully cured cement leads to an increase in the cement's fatigue life, whereas there is disagreement as to whether vacuum mixing the cement constituents leads to an increase in the fatigue life of the fully cured cement (relative to the hand-mixed counterpart). Among the underexplored topics is systematic study of the effect of test frequency on the fatigue results, whereas determination of the optimal concentration of the antibiotic in an antibiotic-loaded cement is an example of the unexplored topics. It is pointed out that resolving the controversies, addressing the underexplored topics, and filling the lacunae will allow comprehensive evaluations of acrylic bone-cement materials to be made. This enhanced body of knowledge will prove invaluable in the continued use of acrylic bone cement as the anchoring agent in cemented arthroplasties.     

Influence of the method of blending an antibiotic powder with an acrylic bone cement powder on physical, mechanical, and thermal properties of the cured cement

Two variants of antibiotic powder-loaded acrylic bone cements (APLBCs) are widely used in primary total joint replacements. In the United States, the antibiotic is manually blended with the powder of the cement at the start of the procedure, while, in Europe, pre-packaged commercially-available APLBCs (in which the blending is carried out using an industrial mixer) are used. Our objective was to investigate the influence of the method of blending gentamicin sulphate with the powder of the Cemex XL formulation on a wide collection of properties of the cured cement. The blending methods used were manual mixing (the MANUAL Set), use of a small-scale, easy-to-use, commercially-available mechanical powder mixer, OmoMix 1 (the MECHANICAL Set), and use of a large-scale industrial mixer (Cemex Genta) [the INDUSTRIAL Set]. In the MECHANICAL and MANUAL Sets, the blending time was 3 min. In preparing the test specimens for each set, the blended powder used contained 4.22 wt% of the gentamicin powder. The properties determined were the strength, modulus, and work-to-fracture (all obtained under four-point bending), plane-strain fracture toughness, Weibull mean fatigue life (fatigue conditions: +/-15 MPa; 2 Hz), activation energy and frequency factor for the cement polymerization process (both determined using differential scanning calorimetry, at heating rates of 5, 10, 15, and 20 Kmin(-1)), the diffusion coefficient for the absorption of phosphate buffered saline, PBS, at 37 degrees C, and the rate of elution of the gentamicin into PBS, at 37 degrees C (E). Also determined were the particle size, particle size distribution, and morphology of the blended powders and of the gentamicin. For each of the cured cement properties (except for E), there is no statistically significant difference between the means for the 3 cements, a finding that parallels the observation that there are no significant differences in either the mean particle size or the morphology of the blended cement powders. Notwithstanding these results, it is suggested that when the powder mixture is blended in the operating room, using the OmoMix 1 is more likely to produce a more consistent and reproducible mixture than when manual mixing is used.