Free radical scavenging alleviates the biomechanical impairment of gamma radiation sterilized bone tissue.

Terminal sterilization of bone allografts by gamma radiation is often essential prior to their clinical use to minimize the risk of infection and disease transmission. While gamma radiation has efficacy superior to other sterilization methods it also impairs the material properties of bone allografts, which may result in premature clinical failure of the allograft. The mechanisms by which gamma radiation sterilization damages bone tissue are not well known although there is evidence that the damage is induced via free radical attack on the collagen. In the light of the existing literature, it was hypothesized that gamma radiation induced biochemical damage to bone's collagen that can be reduced by scavenging for the free radicals generated during the ionizing radiation. It was also hypothesized that this lessening of the extent of biochemical degradation of collagen will be accompanied by alleviation in the extent of biomechanical impairment secondary to gamma radiation sterilization. Standardized tensile test specimens machined from human femoral cortical bone and specimens were assigned to four treatment groups: control, scavenger treated-control, irradiated and scavenger treated-irradiated. Thiourea was selected as the free radical scavenger and it was applied in aqueous form at the concentration of 1.5 M. Monotonic and cyclic mechanical tests were conducted to evaluate the mechanical performance of the treatment groups and the biochemical integrity of collagen molecules were assessed by sodium dodecyl sulfate-polyacrylamide gel electrophoresis. The native mechanical properties of bone tissue did not change by thiourea treatment only. The effect of thiourea treatment on mechanical properties of irradiated specimens were such that the post-yield energy, the fracture energy and the fatigue life of thiourea treated-irradiated treatment group were 1.9-fold, 3.3-fold and 4.7-fold greater than those of the irradiated treatment group, respectively. However, the mechanical function of thiourea treated and irradiated specimens was not to the level of unirradiated controls. The damage occurred through the cleavage of the collagen backbone as revealed by SDS PAGE analysis. Irradiated specimens did not exhibit a noteworthy amount of intact alpha-chains whereas those irradiated in the presence of thiourea demonstrated intact alpha-chains. Results demonstrated that free radical damage is an important pathway of damage, caused by cleaving the collagen backbone. Blocking the activity of free radicals using the scavenger thiourea reduces the extent of damage to collagen, helping to maintain the mechanical strength of sterilized tissue. Therefore, free radical scavenger thiourea has the potential to improve the functional life-time of the allograft component following transplantation.     

The effect of gamma radiation sterilization on the fatigue crack propagation resistance of human cortical bone

BACKGROUND: Clinical evidence has suggested that the rate of fracture in allografts sterilized with gamma radiation may be higher than that in controls. Gamma radiation sterilization has been shown to affect the post-yield properties of bone but not the elastic modulus. Since most allograft fractures occur with subcritical loads during activities of daily living, it may be that the fatigue properties of irradiated allografts are diminished. In this study, the fatigue crack propagation behavior of cortical bone sterilized with gamma radiation was compared with that of gender and age-matched controls. We hypothesized that gamma radiation significantly reduces the resistance of cortical bone to fatigue crack growth. METHODS: Specimens for fatigue crack propagation testing were machined from four pairs of fresh-frozen human femora obtained from four individuals (a younger male, younger female, older male, and older female donor). Half of the specimens were sterilized with 31.7 kGy of gamma radiation. The specimens were cyclically loaded to failure in a servohydraulic testing system, and crack growth was monitored. The cyclic stress intensity factor and the fatigue crack growth rate were calculated to examine the kinetics of fatigue crack growth. Following testing, the damage zone around the fracture plane was analyzed histologically. RESULTS: The morphology and kinetics of crack growth in irradiated specimens differed from the control data. Overall, the irradiated bone was significantly less resistant to fatigue crack growth than was control tissue (p < 0.05). There was less microdamage associated with fracture in the irradiated specimens than in the control specimens, with the exception of the bone from the older female donor. CONCLUSIONS: Gamma radiation sterilization significantly reduces the fatigue crack propagation resistance of cortical bone. Irradiated specimens also demonstrate a smaller amount of microdamage along the fracture plane. These findings may be due to ultrastructural alterations in the collagen matrix caused by radiation. CLINICAL RELEVANCE: This study suggests that, despite having pre-yield mechanical properties that are similar to those of nonirradiated bone, gamma-radiation-sterilized allograft may be more predisposed to fracture even under the subcritical loads that occur during the activities of daily living.     

Irradiation Does Not Modify Mechanical Properties of Cancellous Bone Under Compression

Background

Gamma radiation sterilization can make cortical bone allograft more brittle, but whether it influences mechanical properties and propensity to form microscopic cracks in structurally intact cancellous bone allograft is unknown.

Questions/purposes

We therefore determined the effects of gamma radiation sterilization on structurally intact cancellous bone mechanical properties and damage formation in both low- and high-density femoral cancellous bone (volume fraction 9%–44%).

Methods

We studied 26 cancellous bone cores from the proximal and distal femurs of 10 human female cadavers (49–82 years of age) submitted to a single compressive load beyond yield. Mechanical properties and the formation of microscopic cracks and other tissue damage (identified through fluorochrome staining) were compared between irradiated and control specimens.

Results

We observed no alterations in mechanical properties with gamma radiation sterilization after taking into account variation in specimen porosity. No differences in microscopic tissue damage were observed between the groups.

Conclusions

Although gamma radiation sterilization influences the mechanical properties and failure processes in cortical bone, it does not appear to influence the performance of cancellous bone under uniaxial loading.

Clinical Relevance

Our observations support the use of radiation sterilization on structurally intact cancellous bone allograft.

     

Fracture resistance of gamma radiation sterilized cortical bone allografts.

Gamma radiation is widely used for sterilization of human cortical bone allografts. Previous studies have reported that cortical bone becomes brittle due to gamma radiation sterilization. This embrittlement raises concern about the performance of a radiation sterilized allograft in the presence of a stress concentration that might be surgically introduced or biologically induced. The purpose of this study was to investigate the effect of gamma radiation sterilization on the fracture resistance of human femoral cortical bone in the presence of a stress concentration. Fracture toughness tests of specimens sterilized at a dose of 27.5 kGy and control specimens were conducted transverse and longitudinal to the osteonal orientation of the bone tissue. The formation of damage was monitored with acoustic emission (AE) during testing and was histologically observed following testing. There was a significant decrease in fracture toughness due to irradiation in both crack growth directions. The work-to-fracture was also significantly reduced. It was observed that the ability of bone tissue to undergo damage in the form of microcracks and diffuse damage was significantly impaired due to radiation sterilization as evidenced by decreased AE activity and histological observations. The results of this study suggest that, for cortical bone irradiated at 27.5 kGy, it is easier to initiate and propagate a macrocrack from a stress concentration due to the inhibition of damage formation at and near the crack tip.     

Osteon pullout in the equine third metacarpal bone: effects of ex vivo fatigue.

An important concept in bone mechanics is that osteons influence mechanical properties in several ways, including contributing to toughness and fatigue strength by debonding from the interstitial matrix so as to "bridge" developing cracks. Observations of "pulled out" osteons on fracture surfaces are thought to be indicative of such behavior. We tested the hypothesis that osteon pullout varies with mode of loading (fatigue vs. monotonic), cortical region, elastic modulus, and fatigue life. Mid-diaphseal beams from the dorsal, medial, and lateral regions of the equine third metacarpal bone were fractured in four point bending by monotonic loading to failure under deflection control, with or without 10(5) cycles of previous fatigue loading producing 5000 microstrain (15-20% of the expected failure strain) on the first cycle; or sinusoidal fatigue loading to failure, under load or deflection control, with the initial cycle producing 10,000 microstrain (30-40% of the expected failure strain). Using scanning electron microscopy, percent fracture surface area exhibiting osteon pullout (%OP.Ar) was measured. Monotonically loaded specimens and the compression side of fatigue fracture surfaces exhibited no osteon pullout. In load-controlled fatigue, pullout was present on the tension side of fracture surfaces, was regionally dependent (occurring to a greater amount dorsally), and was correlated negatively with elastic modulus and positively with fatigue life. Regional variation in %OP.Ar was also significant for the pooled (load and deflection controlled) fatigue specimens. %OP.Ar was nearly significantly greater in deflection controlled fatigue specimens than in load-controlled specimens (p=0.059). The data suggest that tensile fatigue loading of cortical bone eventually introduces damage that results in osteonal debonding and pullout, which is also associated with increased fatigue life via mechanisms that are not yet clear.     

A cumulative damage model for bone fracture

A mathematical model is presented to describe the combined time-dependent and cycle-dependent fracture characteristics of devitalized cortical bone. Failure is interpreted based on a linear-life fraction rule, which accounts for cumulative creep and fatigue damage under arbitrary loading histories. The model is successful in describing the influence of loading rate on monotonic tensile strength, the time to failure in constant stress creep-fracture tests, and bone fracture in zero-tension and tension-compression cyclic loading. The possible implications of the model to in vivo bone fracture, deformity, and remodelling in response to various loading histories are considered.     

Assessment of external fixator reusability using load- and cycle-dependent tests

No standard method has been established for investigating repeated use of an external fixator. The purpose of the current study was to establish a fatigue testing method for assessing fixator frame reuse. A unilateral DynaFix trade mark external fixator system was tested using high-load and low-cycle (900-150 N at 5 Hz) and low-load and high-cycle (450-100 N at 10 Hz) tests (assumed one use of 500,000 and 1 million cycles, respectively). These loading conditions were selected to simulate single clinical use and to satisfy Food and Drug Administration requirements. In the high-load low-cycle test, substantial failure of the serrated joint occurred before completion of the first simulated use. In the low-load high-cycle test, all fixators completed three simulated clinical uses without failure, although (1/4) of the serrated joint components had hairline cracks. The high-load low-cycle test identified the fixator components which should be examined and replaced if reuse of the fixator is to be considered. Wear and deformation of the set screw on the rotary joint and telescoping mechanisms were observed in the low-load high-cycle test but not in the high-load low-cycle test. Therefore, if the unilateral DynaFix trade mark fixators are being considered for reusability, the number of reuses should be limited as the whole structure of the device will experience fatigue damage as the loading cycle increases.     

The effect of various sterilization procedures on the osteoinductive properties of demineralized bone matrix]

To minimize potential infection following the transplantation of allogeneic bone, extremely rigorous selection of donors and careful processing and storage of samples are required. Other major problems related to allogeneic transplants, such as reduced osteogenic properties and immunological reactions, led to the development of demineralized bone matrix (DBM). This osteoinductive bone extract is largely free of antigens and is easy to produce. However, to eliminate the potential risk of infection, DBM should be sterilized prior to implantation. The purpose of this study was to investigate the influence of different sterilization techniques on the osteoinductive properties of DBM. A series of 76 cortical defects (drill holes) 0.6 cm in diameter in the tibiae of 11 Merino sheep were filled with DBM in addition to autogeneic and allogeneic cancellous bone. Prior to implantation DBM was sterilized by autoclaving, gamma irradiation, or application of ethylene oxide or ethyl alcohol. A further 12 drill holes were left empty as controls. The formation of new bone was examined 3 and 6 weeks postoperatively, using histological, fluorescent-optical and microradiographical techniques. The amount of newly formed bone was also quantified. Apart from autoclaved DBM all matrix grafts showed excellent new bone formation following sterilization, by far exceeding the formation with allogeneic cancellous bone.     

Shear Strength and Fatigue Properties of Human Cortical Bone Determined from Pure Shear Tests

Shear properties of bone have been inferred from torsion tests. However, torsion often causes spiral fracture planes that correspond to tensile rather than shear failure. We measured the shear properties of human cortical bone in both longitudinal and transverse directions using pure shear tests. Shearing applied transverse to the bone long axis caused fracture along a 45 degrees plane that coincided with maximum tension. This fracture pattern is similar to spiral fractures caused by torsion. Shear strength along the bone axis was 51.6 MPa or about 35% less than that determined using torsion tests. Fatigue tests of human cortical bone in pure shear were conducted. The results agreed well with previous measurements of cortical bone fatigue life in tension and compression, when normalized to strength. Using tibial shear strain magnitudes measured previously for human volunteers, we estimated the fatigue life of cortical bone for different activities, and speculate that shear fatigue failure is a probable cause of tibial stress fractures resulting from impact loading.     

Degradation of bone structural properties by accumulation and coalescence of microcracks

Failure of bone adaptation to protect the skeleton from fatigue fracture is common, and site-specific accumulation and coalescence of microcracking in regions of high strain during cyclic loading is considered a key factor that decreases the resistance of whole bones to fracture. We investigated the effect of cyclic fatigue loading on the monotonic structural properties of the rat ulna during accumulation and coalescence of microcracks. Cyclic end-loading of the ulna was performed at 4 Hz ex vivo at an initial peak strain of -6000 muepsilon to 20% loss of stiffness (n = 7) or 40% loss of stiffness (n = 7) bilaterally. A 0% loss of stiffness monotonically loaded control group (n = 7) was also included. Volumetric bone mineral density (vBMD), ultimate strength (F(u)), stiffness (S), and energy-to-failure (U) were determined in one ulna and in the contralateral ulna vBMD, cortical bone area (B.Ar), maximum and minimum second moments of inertia (I(MAX) and I(MIN)), microcrack density (Cr.Dn), microcrack mean length (Cr.Le), and microcrack surface density (Cr.S.Dn) were determined. In two additional groups of rats, cyclic end-loading of the ulna was also performed ex vivo unilaterally to 20% loss of stiffness (n = 10) and 40% loss of stiffness (n = 10) and then vBMD, F(u), S, U, B.Ar, I(MAX), and I(MIN) were determined bilaterally. Fatigue loading had incremental degradative effects on ulna structural properties. This decreased resistance to fracture was associated with accumulation and coalescence of branching arrays of microcracks within the cortex of the ulna. Microcracking was most prominent in the middiaphysis and corresponded to the region of the bone that fractured during monotonic structural testing. Fatigue loading influenced the relationship between bone cross-sectional geometry and vBMD and ulna structural properties. At 40% loss of stiffness, F(u), S, and U were all significantly correlated with cross-sectional bone geometry and vBMD, whereas this was not the case at 20% loss of stiffness and with the 0% loss of stiffness monotonic control ulnae. We also found a biologically significant individual animal effect. Larger ulnae required a higher number of load cycles for fatigue to develop, retained higher strength, and accumulated a greater amount of microcracking at the end of the cyclic fatigue testing. Small increases in bone size and density can substantially improve the resistance of whole bones to fracture as microcracking accumulates and coalesces during cyclic fatigue loading.     

Mechanical strength of cortical allografts with gamma radiation versus ethylene oxide sterilization

We investigated the effects of gamma irradiation versus ethylene oxide (ETO) sterilization on the mechanical strength of cortical bone grafts. Tibias were collected from cadavers of mature goats. Sixty test specimens were randomized into four groups: fresh (no processing), frozen (freezing at -70 degrees C), gamma-irradiated, and ETO-sterilized specimens. Torsion, three-point bending, and compression testing were separately performed with a material testing machine. Parameters studied included maximum stress, strain, deflection, extension, load, shear modulus, and E-modulus. Compared with findings for the fresh specimens, findings were as follows for gamma-irradiated specimens: maximal shear modulus, reduced by 48%; shear stress, by 55%; deflection, by 71%; bending stress, by 51%; bending strain, by 74%; extension, by 60%; and compression strain, by 50%. However, there were no reductions in those parameters for the frozen specimens or the ETO-sterilized specimens. These findings confirm that shear, bending, and compression strength of cortical allografts are weakened by gamma irradiation at room temperature. To maintain optimum mechanical properties, ETO sterilization of allografts is better than gamma sterilization, especially for cortical bone, because it is usually used in load-bearing settings.     

Fracture and fatigue properties of acrylic bone cement: the effects of mixing method, sterilization treatment, and molecular weight

The purpose of this study was to characterize the relative and combined effects of sterilization, molecular weight, and mixing method on the fracture and fatigue performance of acrylic bone cement. Palacos R brand bone cement powder was sterilized using ethylene oxide gas (EtO) or gamma irradiation. Nonsterile material was used as a control. Molecular weights of the bone-cement powders and cured cements were measured using gel permeation chromatography. Hand and vacuum mixing were employed to mold single edge-notched bend specimens for fracture toughness testing. Molded dog-bone specimens were used for fatigue tests. Electron microscopy was used to study fracture mechanisms. Analysis of variance and Student t-tests were used to compare fracture and fatigue performance between sterilization and mixing groups. Our results indicate that vacuum mixing improved significantly the fracture and fatigue resistance (P<.05, P<.07) over hand mixing in radiation-sterilized and EtO-sterilized groups. In vacuum-mixed cement, the degradation in molecular weight resulting from gamma irradiation decreased fracture resistance significantly when compared with EtO sterilization and control (P<.05). A corresponding decrease in fatigue resistance was observed in the cement that was degraded severely by a radiation dose of 10 MRad (P<.05). In contrast, EtO sterilization did not result in a significantly different fracture resistance when compared with unsterilized controls for vacuum-mixed cement (P>.1). For hand-mixed cement, fracture and fatigue resistance appeared to be independent of sterilization method. This independence is believed to be the result of higher porosity that compromised the mechanical properties and obscures any effect of sterilization. Our results indicate that a combination of nonionizing sterilization and vacuum mixing resulted in the best mechanical performance and is most likely to contribute to enhanced longevity in vivo.     

The effects of various cleaning and sterilization processes on allograft bone incorporation

Although bone allografts have a long history of safe and effective clinical use, there is great variability in tissue processing and sterilization processes. Chemical and gamma radiation sterilization are commonly performed on allografts, and numerous animal and clinical studies have examined their integration into host bone. The objective of this literature review was to assess the effects of various cleaning and sterilization processes on the incorporation of allograft bone.     

Irradiation has no effect on the incorporation of impacted morselized bone: a bone chamber study in goats

Background Gamma irradiation has been widely used for sterilization of bone allografts. However, gamma irradiation alters proteins. This is favorable when it reduces immunogenicity, but is undesirable when osteoinductive proteins are damaged. Although the effect of gamma irradiation on BMPs has been studied, the effect of irradiation on the process of incorporation of morselized bone chips remains unclear. We studied the effects of sterilization by gamma irradiation on the incorporation of impacted morselized allografts.

Methods Bone chambers with impacted allografts, rinsed impacted allografts, allografts that were rinsed and subsequently irradiated, and an empty control were implanted in proximal medial tibiae of goats. Incorporation was evaluated using histology and histomorphometry.

Results Histology revealed evidence of bone graft incorporation, which proceeded in a similar way in unprocessed, rinsed, and both rinsed and irradiated bone grafts. After 12 weeks, no difference in bone and tissue ingrowth was found between the unprocessed, the rinsed, and the rinsed and subsequently irradiated allografts. The amount of unresorbed graft remnant was highest in the unprocessed bone grafts.

Interpretation We conclude that sterilization with gamma irradiation does not influence the incorporation of impacted rinsed bone allografts.     

Exponential model for the tensile true stress-strain behavior of as-irradiated and oxidatively degraded ultra high molecular weight polyethylene

Following sterilization by gamma radiation, ultra high molecular weight polyethylene components for total joint replacement undergo oxidative degradation upon exposure to air and the in vivo environment. Oxidative degradation is accompanied by an increase in density. The primary objective of this study was to develop a mathematical model to predict the monotonic tensile mechanical behavior of these sterilized components as a function of changes in density arising from oxidative degradation. Tensile specimens of ultra high molecular weight polyethylene were sterilized with gamma radiation and then oxidatively degraded in an air furnace. The average density of each specimen was measured using a density gradient column. Differential scanning calorimetry and Fourier transform infrared spectroscopy were conducted on selected specimens to characterize the physical and chemical changes due to accelerated aging as opposed to ambient shelf aging. Mechanical testing was conducted in monotonic uniaxial tension. An exponential model was fitted to the true stress-strain data (up to a true strain of 0.12). The observed fitted stress had a correlation coefficient of 0.996. The model permits a quantitative prediction of the association between the true stress-strain curve and density for the ultra high molecular weight polyethylene components. The proposed exponential model effectively describes changes in the large-strain monotonic tensile behavior of as-irradiated and oxidatively degraded ultra high molecular weight polyethylene components.     

The associations between mineral crystallinity and the mechanical properties of human cortical bone

It is well known that the amount of mineralization renders bone its stiffness. However, besides the mere amount of the mineral phase, size and shape of carbonated apatite crystals are postulated to affect the mechanical properties of bone tissue as predicted by composite mechanics models. Despite this predictive evidence, there is little experimental insight on the relation between the characteristics of mineral crystals and hard tissue mechanics. In this study, Raman spectroscopy was used to provide information on the crystallinity of bone's mineral phase, a parameter which is an overall indicator of mineral crystal size and stoichiometric perfection. Raman scans and mechanical tests (monotonic and fatigue; n=64 each) were performed on the anterior, medial, lateral and posterior quadrant sections of 16 human cadaveric femurs (52 y.o.-85 y.o.). The reported coefficient of determination values (R(2)) were adjusted for the effects of age to bring out the unbiased contribution of crystallinity. Crystallinity was able to explain 6.7% to 48.3% of the variation in monotonic mechanical properties. Results indicated that the tissue-level strength and stiffness increased with increasing crystallinity while the ductility reduced. Crystallinity explained 11.3% to 63.5% of the variation in fatigue properties. Moduli of specimens with greater crystallinity degraded at a slower rate and, also, they had longer fatigue lives. However, not every anatomical quadrant displayed these relationships. In conclusion, these results acknowledge crystal properties as an important bone quality factor and raise the possibility that aberrations in these properties may contribute to senile osteoporotic fractures.     

Model of flexural fatigue damage accumulation for cortical bone

Analytical models that predict modulus degradation in cortical bone subjected to uniaxial fatigue loading in tension and compression are presented. On the basis of experimental observations, damage was modeled as self-limiting for tension but not for compression. These mechanistic uniaxial damage models were then developed into a model for flexural fatigue of cortical bone based on laminated beam theory. The unknown coefficients in the uniaxial damage models were obtained by successfully fitting the resulting equations to uniaxial fatigue data from the literature on human cortical bone in tension and compression. Then, the predictions of the flexural model for the behavior of human cortical bone were compared with experimental results from a small but independent set of specimens tested at three different ranges of load in our laboratory. The behavior of the modulus degradation curves and the flexural fatigue lives of the specimens were in excellent agreement with the predictions of the model.     

Biomechanical analysis of allograft bone treated with a novel tissue sterilization process.

BACKGROUND CONTEXT: Several methods to sterilize allograft bone exist, including gamma irradiation and freeze-drying, which can alter the mechanical properties of the graft. Efforts are under way to develop a method for processing osseous allograft that maintains structural integrity. Herein is presented one such method. PURPOSE: To analyze the mechanical properties, compared with nontreated controls, of a novel sterilization process for allograft cortical bone. STUDY DESIGN/SETTING: A controlled biomechanical evaluation of allograft bone under various types of loading after a novel sterilization treatment. PATIENT SAMPLE: Not applicable; basic science. OUTCOME MEASURES: The load to failure was recorded for both the study and control groups, and statistical analysis of these results was performed. Significance level (alpha) and power (beta) were set to 0.05 and 0.90, respectively. Single-factor analysis of variance (ANOVA) was used to detect significant differences between the treated and untreated groups. A post-experimental power analysis was performed for each of the response variables. METHODS: Cortical tibia and femur samples from seven cadaveric donors (mean age 68.7 years) were treated with Biocleanse and compared with untreated samples with regard to density and strength. All samples were loaded to failure under diametral and biaxial compression, shear, and three-point bending. RESULTS: Statistical analysis was done on the density and failure stress for all modes of loading. ANOVA did not indicate a significant (p>.05) effect of treatment on the density except for the axial and biaxial specimens (p<.05). ANOVA analysis of failure stress demonstrated no significant differences (p>.05) between cortical bone treated with Biocleanse and untreated specimens under all four types of mechanical loading. Post-experimental power analysis revealed power to be greater than 0.9 for each test. CONCLUSIONS: Sterilization of allograft bone with Biocleanse does not significantly alter the mechanical properties when compared with untreated samples. The effect of this sterilization process on the osteoconductive and osteoinductive properties of allograft bone must be determined.     

Fracture and fatigue properties of acrylic bone cement

The purpose of this study was to characterize the relative and combined effects of sterilization, molecular weight, and mixing method on the fracture and fatigue performance of acrylic bone cement. Palacos® R brand bone cement powder was sterilized using ethylene oxide gas (EtO) or gamma irradiation. Nonsterile material was used as a control. Molecular weights of the bone-cement powders and cured cements were measured using gel permeation chromatography. Hand and vacuum mixing were employed to mold single edge-notched bend specimens for fracture toughness testing. Molded dog-bone specimens were used for fatigue tests. Electron microscopy was used to study fracture mechanisms. Analysis of variance and Student t-tests were used to compare fracture and fatigue performance between sterilization and mixing groups. Our results indicate that vacuum mixing improved significantly the fracture and fatigue resistance (P < .05, P < .07) over hand mixing in radiation-sterilized and EtO-sterilized groups. In vacuum-mixed cement, the degradation in molecular weight resulting from gamma irradiation decreased fracture resistance significantly when compared with EtO sterilization and control (P < .05). A corresponding decrease in fatigue resistance was observed in the cement that was degraded severely by a radiation dose of 10 MRad (P < .05). In contrast, EtO sterilization did not result in a significantly different fracture resistance when compared with unsterilized controls for vacuum-mixed cement (P > .1). For hand-mixed cement, fracture and fatigue resistance appeared to be independent of sterilization method. This independence is believed to be the result of higher porosity that compromised the mechanical properties and obscures any effect of sterilization. Our results indicate that a combination of nonionizing sterilization and vacuum mixing resulted in the best mechanical performance and is most likely to contribute to enhanced longevity in vivo.     

Prediction of fatigue failure of a total knee replacement tibial plateau using finite element analysis

Recent reports of total knee prosthesis fractures have raised concerns over the long-term structural integrity of metal-backed tibial components. Both the development of a fibrous tissue membrane under the tibial plateau of a total knee prosthesis and loading conditions may seriously alter the fatigue life of the metal tibial tray. The effects of the cement and fibrous tissue at the bone-prosthesis interface were studied. Using the method of three-dimensional finite element analysis, peak loads of normal gait were simulated at several locations on the plateau of a generic, single-stemmed, porous-coated, CoCrMo tibial component model, providing information on the effect of abnormal loading patterns. According to the analysis, stresses below the material endurance limit are predicted throughout the prosthesis prior to the development of the fibrous membrane. However, stresses exceeding the yield strength of the material are predicted in a prosthesis that is supported by a fully developed 1 mm membrane, meaning that it has a markedly increased risk of low-cycle fatigue failure. Lateral displacement of the loading is detrimental to prosthesis life because maximum stress increases 100% while posterior displacement of the loading increases maximum stress by only 30%. Anterior loading creates stresses similar to those created by central loading. Because of their susceptibility to low-cycle fatigue failure, simple, single-stemmed prostheses are not recommended in cases of questionable bone stock unless modified. Several design alternatives are proposed.