Notch strengthening and hardening behavior of conventional and highly crosslinked UHMWPE under applied tensile loading.

This study examined the engineering and true axial stress-strain behavior of smooth cylindrical and shallow and deep notched cylindrical test specimens, under applied axial tensile loading using non-contacting methods, of both conventional and highly crosslinked ultra-high molecular weight polyethylenes (UHMWPEs). The smooth specimens experienced a uniaxial stress state, while the notched specimens experienced a triaxial stress state in the vicinity of the notch. Materials were all prepared from a single batch of medical grade GUR 1050 resin (Ticona, Bayport, TX). The two conventional UHMWPEs were as-received (virgin) and gamma radiation sterilized at 30 kGy in a nitrogen atmosphere (radiation sterilized). The two highly crosslinked UHMWPEs were each irradiated at 100 kGy and then post-processed with one of either of the two thermal treatments: annealing, which was done below the melt transition temperature (T(m)), at 110 degrees C for two hours (110 degrees C-annealed), and remelting, which was done above T(m), at 150 degrees C (150 degrees C-remelted). All of the materials showed notch strengthening; that is, a significant elevation of axial yield properties (both engineering and true) for the shallow and deep notched conditions. Axial ultimate properties (engineering and true) were significantly decreased for the notched conditions compared with the smooth condition. Hardening ratios (both true and engineering), which are defined in this work as the ratio of ultimate stress or strain to yield stress or strain, were also found to significantly decrease with notching. The extent of change was dependent on the UHMWPE material. The micromechanism of fracture differed between the smooth and notched conditions. This study suggests that notches inherent in the design of UHMWPE joint replacement components (posts, undercuts, grooves) will have different notch sensitivities depending on the UHMWPE formulation.

Molecular chain stretch is a multiaxial failure criterion for conventional and highly crosslinked UHMWPE.

The development of accurate theoretical failure, fatigue, and wear models for ultra-high molecular weight polyethylene (UHMWPE) is an important step towards better understanding the micromechanisms of the surface damage that occur in load bearing orthopaedic components and improving the lifetime of joint arthoplasties. Previous attempts to analytically predict the clinically observed damage, wear, and fatigue failure modes have met with limited success due to the complicated interaction between microstructural deformations and continuum level stresses. In this work, we examined monotonic uniaxial and multiaxial loading to failure of UHMWPE using eight failure criteria (maximum principal stress, Mises stress, Tresca stress, hydrostatic stress, Coulomb stress, maximum principal strain, Mises strain, and chain stretch). The quality of the predictions of the different models was assessed by comparing uniaxial tension and small punch test data at different rates with the failure model predictions. The experimental data were obtained for two conventional (unirradiated and gamma radiation sterilized in nitrogen) and two highly crosslinked (150kGy, remelted and annealed) UHMWPE materials. Of the different failures models examined, the chain stretch failure model was found to capture uniaxial and multiaxial failure data most accurately for all of the UHMWPE materials. In addition, the chain stretch failure criterion can readily be calculated for contemporary UHMWPE materials based on available uniaxial tension data. These results lay the foundation for future developments of damage and wear models capable of predicting multiaxial failure under cyclic loading conditions.

Failure property distributions for conventional and highly crosslinked ultrahigh molecular weight polyethylenes.

To make stochastic (probabilistic) failure predictions of a conventional or highly crosslinked ultrahigh molecular weight polyethylene (UHMWPE) material, not only must a failure criterion be defined, but it is also necessary to specify a probability distribution of the failure strength. This study sought to evaluate both parametric and nonparametric statistical approaches to describing the failure properties of UHMWPE, based on the Normal and Weibull model distributions, respectively. Because fatigue and fracture properties of materials have historically been well described with the use of Weibull statistics, it was expected that a nonparametric approach would provide a better fit of the failure distributions than the parametric approach. The ultimate true stress, true strain, and ultimate chain stretch data at failure were analyzed from 60 tensile tests conducted previously. The ultimate load and ultimate displacement from 121 small punch tests conducted previously were also analyzed. It was found that both Normal and Weibull models provide a reasonable description of the central tendency of the failure distribution. The principal difference between the Normal and Weibull models can be appreciated in the predicted lower-bound response at the tail end of the distribution. The data support the use of both parametric and nonparametric methods to bracket the lower-bound failure prediction in order to simulate the failure threshold for UHMWPE.

Cyclic steady state stress-strain behavior of UHMW polyethylene.

To increase the long-term performance of total joint replacements, finite element analyses of ultra high molecular weight polyethylene (UHMWPE) components have been conducted to predict the effect of load on the stress and strain distributions occurring on and within these components. Early models incorporated the monotonic behavior of UHMWPE without considering the unloading and cyclic loading behavior. However, UHMWPE components undergo cyclic loading during use and at least two wear damage modes (pitting and delamination) are thought to be associated with the fatigue fracture properties of UHMWPE. The objective of this study was to examine the fully reversed uniaxial tension/compression cyclic steady state stress-strain behavior of UHMWPE as a first step towards developing a cyclic constitutive relationship for UHMWPE. The hypothesis that cycling results in a permanent change in the stress-strain relationship, that is, that the cyclic steady state represents a new cyclically stabilized state, was examined. It was found that, like other ductile polymers, UHMWPE substantially cyclically softens under fully reversed uniaxial straining. More cyclic softening occurred in tension than in compression. Furthermore, cyclic steady state was attained, but not cyclic stability. It is suggested that it may be more appropriate to base a material constitutive relationship for UHMWPE for finite element analyses of components upon a cyclically modified stress-strain relationship.

An augmented hybrid constitutive model for simulation of unloading and cyclic loading behavior of conventional and highly crosslinked UHMWPE.

Ultra-high molecular weight polyethylene (UHMWPE) is extensively used in total joint replacements. Wear, fatigue, and fracture have limited the longevity of UHMWPE components. For this reason, significant effort has been directed towards understanding the failure and wear mechanisms of UHMWPE, both at a micro-scale and a macro-scale, within the context of joint replacements. We have previously developed, calibrated, and validated a constitutive model for predicting the loading response of conventional and highly crosslinked UHMWPE under multiaxial loading conditions (Biomaterials 24 (2003) 1365). However, to simulate in vivo changes to orthopedic components, accurate simulation of unloading behavior is of equal importance to the loading phase of the duty cycle. Consequently, in this study we have focused on understanding and predicting the mechanical response of UHMWPE during uniaxial unloading. Specifically, we have augmented our previously developed constitutive model to also allow for accurate predictions of the unloading behavior of conventional and highly crosslinked UHMWPE during cyclic loading. It is shown that our augmented hybrid model accurately captures the experimentally observed characteristics, including uniaxial cyclic loading, large strain tension, rate-effects, and multiaxial deformation histories. The augmented hybrid constitutive model will be used as a critical building block in future studies of fatigue, failure, and wear of UHMWPE.

Prediction of multiaxial mechanical behavior for conventional and highly crosslinked UHMWPE using a hybrid constitutive model.

The development of theoretical failure, fatigue, and wear models for ultra-high molecular weight polyethylene (UHMWPE) used in joint replacements has been hindered by the lack of a validated constitutive model that can accurately predict large deformation mechanical behavior under clinically relevant, multiaxial loading conditions. Recently, a new Hybrid constitutive model for unirradiated UHMWPE was developed Bergström et al., (Biomaterials 23 (2002) 2329) based on a physics-motivated framework which incorporates the governing micro-mechanisms of polymers into an effective and accurate continuum representation. The goal of the present study was to compare the predictive capability of the new Hybrid model with the J(2)-plasticity model for four conventional and highly crosslinked UHMWPE materials during multiaxial loading. After calibration under uniaxial loading, the predictive capabilities of the J(2)-plasticity and Hybrid model were tested by comparing the load-displacement curves from experimental multiaxial (small punch) tests with simulated load-displacement curves calculated using a finite element model of the experimental apparatus. The quality of the model predictions was quantified using the coefficient of determination (r(2)). The results of the study demonstrate that the Hybrid model outperforms the J(2)-plasticity model both for combined uniaxial tension and compression predictions and for simulating multiaxial large deformation mechanical behavior produced by the small punch test. The results further suggest that the parameters of the HM may be generalizable for a wide range of conventional, highly crosslinked, and thermally treated UHMWPE materials, based on the characterization of four material properties related to the elastic modulus, yield stress, rate of strain hardening, and locking stretch of the polymer chains. Most importantly, from a practical perspective, these four key material properties for the Hybrid constitutive model can be measured by relatively simple uniaxial tension or compression tests.

Failure micromechanisms during uniaxial tensile fracture of conventional and highly crosslinked ultra-high molecular weight polyethylenes used in total joint replacements.

Highly crosslinked UHMWPEs have demonstrated improved in vitro wear properties; however, there is concern regarding loss of fracture resistance and ductility. The goals of this study were to evaluate the micromechanisms of failure under uniaxial tension and to determine the effect of gamma radiation-induced crosslinking and post-irradiation thermal processing on the estimated fracture toughness (Kc) of UHMWPE. Kc was estimated for two conventional and two highly crosslinked UHMWPE materials from tensile tests. A 32% decrease in Kc was found following crosslinking at 100kGy. The highly crosslinked materials also exhibited less ductile fracture behavior. Kc was slightly dependent on displacement rate but was insensitive to changes in crystallinity (and thus, to thermal processing). The same basic failure mechanism, microvoid nucleation and slow coalescence followed by comparatively rapid fracture after the defect reached a critical size, was observed for all of the conventional and highly crosslinked UHMWPE specimens. These observations will be used in the development of a theoretical failure model for highly crosslinked UHMWPE, which, in conjunction with a validated constitutive model, will provide the tools for predicting the risk of failure in orthopaedic components, fabricated from these new orthopaedic bearing materials.

The relationship between the clinical performance and large deformation mechanical behavior of retrieved UHMWPE tibial inserts.

Many aspects of the proposed relationship between material properties and clinical performance of UHMWPE components remain unclear. In this study, we explored the hypothesis that the clinical performance of tibial inserts is directly related to its large-deformation mechanical behavior measured near the articulating surface. Retrieval analysis was performed on three conventional UHMWPE and three Hylamer-M tibial components of the same design and manufacturer. Samples of material were then obtained from the worn regions of each implant and subjected to mechanical characterization using the small punch test. Statistically significant relationships were observed between the metrics of the small punch test and the total damage score and the burnishing damage score of the implants. We also examined the near-surface morphology of the retrievals using transmission electron microscopy. TEM analysis revealed lamellar alignment at and below the wear surfaces of the conventional UHMWPE retrievals up to a maximum depth of approximately 8 microm, consistent with large-deformation crystalline plasticity. The depth of the plasticity-induced damage layer varied not only between the retrievals, but also between the conventional UHMWPE and Hylamer-M components. Thus, the results of this study support the hypothesis that the clinical performance of UHMWPE tibial inserts is related to the large-deformation mechanical behavior measured near the articulating surface.

Constitutive modeling of ultra-high molecular weight polyethylene under large-deformation and cyclic loading conditions.

When subjected to a monotonically increasing deformation state, the mechanical behavior of UHMWPE is characterized by a linear elastic response followed by distributed yielding and strain hardening at large deformations. During the unloading phases of an applied cyclic deformation process, the response is characterized by nonlinear recovery driven by the release of stored internal energy. A number of different constitutive theories can be used to model these experimentally observed events. We compare the ability of the J2-plasticity theory, the "Arruda-Boyce" model, the "Hasan-Boyce" model, and the "Bergström-Boyce" model to reproduce the observed mechanical behavior of ultra-high molecular weight polyethylene (UHMWPE). In addition a new hybrid model is proposed, which incorporates many features of the previous theories. This hybrid model is shown to most effectively predict the experimentally observed mechanical behavior of UHMWPE.

Thermomechanical behavior of virgin and highly crosslinked ultra-high molecular weight polyethylene used in total joint replacements.

Three series of uniaxial tension and compression tests were conducted on two conventional and two highly crosslinked ultra-high molecular weight polyethylenes (UHMWPEs) all prepared from the same lot of medical grade GUR 1050. The conventional materials were unirradiated (control) and gamma irradiated in nitrogen with a dose of 30 kGy. The highly crosslinked UHMWPEs were gamma irradiated at room temperature with 100 kGy and then thermally processed by either annealing below the melt transition at 100 degrees C or by remelting above the melt transition at 150 degrees C. The true stress-strain behavior of the four UHMWPE materials was characterized as a function of strain rate (between 0.02 and 0.10 s(-1)) and test temperature (20-60 degrees C). Although annealing and remelting of UHMWPE are primarily considered as methods of improving oxidation resistance, thermal processing was found to significantly impact the crystallinity, and hence the mechanical behavior, of the highly crosslinked UHMWPE. The crystallinity and radiation dose were key predictors of the uniaxial yielding, plastic flow, and failure properties of conventional and highly crosslinked UHMWPEs. The thermomechanical behavior of UHMWPE was accurately predicted using an Arrhenius model, and the associated activation energies for thermal softening were related to the crystallinity of the polymers. The conventional and highly crosslinked UHMWPEs exhibited low strain rate dependence in power law relationships, comparable to metals. In light of the unifying trends observed in the true stress-strain curves of the four materials investigated in this study, both crosslinking (governed by the gamma radiation dose) and crystallinity (governed by the thermal processing) were found to be useful predictors of the mechanical behavior of UHMWPE for a wide range of test temperatures and rates. The data collected in this study will be used to develop constitutive models based on the physics of polymer systems for predicting the thermomechanical behavior of conventional and crosslinked UHMWPE used in total joint replacements.

Degradation rate of ultra-high molecular weight polyethylene.

Ultra-high molecular weight polyethylene components for total joint replacement chemically degrade before and after implantation, and the degradation is associated with an increase in density. The goal of this study was to determine the average rate of density change in these components following sterilization by gamma radiation in air as a function of shelf age and implantation time. Using the density gradient column method, density profiles were obtained through the thickness from loaded and unloaded regions of 10 retrieved Insall-Burstein/Posterior-Stabilized II tibial components and one operating-room inventory component for which the initial density profile and patient history (if applicable) were known. The average density of the components increased at a constant rate of 0.000186 g/cc/month during the first 50 months after sterilization (r2 = 0.54) but was not significantly affected by loading (p > 0.05). The quantitative degradation rates may be useful to help verify kinetic models to predict bulk degradative changes on the basis of micro-structural and chemical processes. This research also suggests the hypothesis that degradation of ultra-high molecular weight polyethylene can be modeled in terms of changes in bulk or average properties.

Fatigue crack propagation behavior of ultrahigh molecular weight polyethylene.

The relative fatigue crack propagation resistance of plain and carbon fiber-reinforced ultrahigh molecular weight polyethylene (UHMWPE) was determined from cyclic loading tests performed on compact tension specimens machined from the tibial components of total knee prostheses. Both materials were characterized by dynamic mechanical spectroscopy, X-ray diffraction, and differential scanning calorimetry. The cyclic tests used loading in laboratory air at 5 Hz using a sinusoidal wave form. Dynamic mechanical spectroscopy showed that the reinforced UHMWPE had a higher elastic storage modulus than the plain UHMWPE, whereas X-ray diffraction and differential scanning calorimetry showed that the percent crystallinity and degree of order in the crystalline regions were similar for the two materials. Fatigue crack propagation in both materials proved to be very sensitive to small changes in the applied cyclic stress intensity range. A 10% increase in stress intensity resulted in approximately an order of magnitude increase in fatigue crack growth rate. The fatigue crack propagation resistance of the reinforced UHMWPE was found to be significantly worse than that of the plain UHMWPE. This result was attributed to poor bonding between the carbon fibers and the UHMWPE matrix and the ductile nature of the matrix itself.

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.

Cyclic compressive loading results in fatigue cracks in ultra high molecular weight polyethylene.

Wear damage to the articulating surfaces of total joint components made of ultra high molecular weight polyethylene is associated with a fatigue fracture mechanism, despite the fact that these surfaces are subjected to primarily compressive and compressive-tensile cyclic stresses. The question arises as to whether fatigue cracks will form under such loading conditions. In this study, we experimentally demonstrated that fatigue cracks could be initiated and propagated in notched ultra high molecular weight polyethylene specimens subjected to fully compressive and compressive-tensile cyclic loading. Under these loading conditions, growth of fatigue cracks was limited: the cracks arrested without catastrophic failure of the test specimens. The final length of the crack was dependent on the load ratio of the fatigue cycle; fatigue cracks propagated to greater lengths as the load ratio was increased.

Analysis of surface damage in retrieved carbon fiber-reinforced and plain polyethylene tibial components from posterior stabilized total knee replacements.

The performance of carbon fiber-reinforced ultra-high molecular weight polyethylene was compared with that of plain (non-reinforced) polyethylene on the basis of the damage that was observed on the articulating surfaces of retrieved tibial components of total knee prostheses. Established microscopy techniques for subjectively grading the presence and extent of surface damage and the histological structure of the surrounding tissues were used to evaluate twenty-six carbon fiber-reinforced and twenty plain polyethylene components that had been retrieved after an average of twenty-one months of implantation. All of the tibial components were from the same design of total knee replacement. The two groups of patients from whom the components were retrieved did not differ with regard to weight, the length of time that the component had been implanted, the radiographic position and angular alignment of the component, the original diagnosis, or the reason for removal of the component. The amounts and types of damage that were observed did not differ for the two materials. For both materials, the amount of damage was directly related to the length of time that the component had been implanted. The histological appearance of tissues from the area around the component did not differ for the two materials, except for the presence of fragments of carbon fiber in many of the samples from the areas around carbon fiber-reinforced components.

The effect of centrifugation on the fracture properties of acrylic bone cements.

In this study, centrifugation did not alter the static or cyclic fracture properties of bone cement. Tests of fracture toughness and fatigue-crack propagation of centrifuged specimens of commercial cements (with and without antibiotic additions) demonstrated no significant difference from control values. Among the cements tested, Palacos (with and without antibiotic) was found to have a significantly higher fracture toughness than either Simplex or Zimmer. We attributed this difference in fracture toughness to the higher molecular weight measured for the Palacos cements. For the tested cements, only Simplex had a significantly greater volume contraction on setting due to centrifugation. The results of our study demonstrate that centrifugation of bone cement does not improve the cement's resistance to fracture in the presence of surface imperfections, such as those found at the bone-cement interface.

Post-irradiation aging of ultra-high molecular weight polyethylene.

A study was performed to determine the time-course of oxidative degradation and the extent to which the degradation proceeded through the bulk of ultra-high molecular weight polyethylene joint components that had been irradiated and stored on a shelf. Standardized cylindrical samples, taken from a single batch of extruded polyethylene, were cleaned, packaged, and sterilized according to protocols used for commercial joint-replacement components. After sterilization, the samples were stored in the packages for time-periods of one day to more than one year. At each interval studied, thin sections were cut as a function of depth into the bulk of the sample and were used to determine the density and the infrared spectra. Marked alterations in the density and the infrared spectra consistent with continuing oxidative degradation occurred throughout the year of storage on the shelf. The alterations were most severe near the surface of the samples.

Polyethylene and metal debris generated by non-articulating surfaces of modular acetabular components.

We report a prospective study of the liner-metal interfaces of modular uncemented acetabular components as sources of debris. We collected the pseudomembrane from the screw-cup junction and the empty screw holes of the metal backing of 19 acetabula after an average implantation of 22 months. Associated osteolytic lesions were separately collected in two cases. The back surfaces of the liners and the screws were examined for damage, and some liners were scanned by electron microscopy. The tissues were studied histologically and by atomic absorption spectrophotometry to measure titanium content. The pseudomembrane from the screw-cup junction contained polyethylene debris in seven specimens and metal debris in ten. The material from empty screw holes was necrotic tissue or dense fibroconnective tissue with a proliferative histiocytic infiltrate and foreign-body giant-cell reaction. It contained polyethylene debris in 14 cases and metal in five. The two acetabular osteolytic lesions also showed a foreign-body giant-cell reaction to particulate debris. The average titanium levels in pseudomembranes from the screw-cup junction and the empty screw holes were 959 micrograms/g (48 to 11,900) and 74 micrograms/g (0.72 to 331) respectively. The tissue from the two lytic lesions showed average titanium levels of 139 and 147 micrograms/g respectively. The back surfaces of the PE liners showed surface deformation, burnishing, and embedded metal debris. All 30 retrieved screws demonstrated fretting at the base of the head and on the proximal shaft. Non-articular modular junctions create new interfaces for the generation of particulate debris, which may cause granulomatous reaction.

Acetabular cup wear in total hip arthroplasty.

Clinical, pathologic, radiographic, and biomechanical factors of 10 severely worn retrieved Charnley acetabular cups were examined to determine whether these factors influenced cup wear. Change in cup thickness was found to be linear with time. It was found that the actual change in cup thickness was not significantly different from the radiographic change in cup thickness. No correlation was found with the other clinical or radiographic factors.

Osseointegration of preformed polymethylmethacrylate craniofacial prostheses coated with bone marrow-impregnated poly (DL-lactic-co-glycolic acid) foam.

Osseointegration of bone marrow-PLGA-coated, preformed polymethylmethacrylate cranioplasties offers the possibility of reducing: operative time, periimplant seroma and infection, metallic fixation, and periprosthetic resorption following surgical skull remodeling. These alloplastic materials are FDA-approved but previously have not been used together to promote cranioplasty incorporation. The objective of this study was to determine whether the use of PLGA foam coating improves host osseointegration of preformed, textured, polymethylmethacrylate prosthetic cranioplasties. A critical-sized cranial defect was created in two groups of 10 and one group of three rabbits. The defect was filled with either a textured, preformed polymethylmethacrylate disc or a textured, preformed polymethylmethacrylate disc coated with poly (DL-lactic-co-glycolic acid). Both implants were immersed in autologous bone marrow for 20 minutes before implantation. Half of each group of 10 were killed at 3 weeks, and the remainder at 6 weeks. A third group of three rabbits with excised periosteum was evaluated at 6 weeks. Histologic analysis of the discs determined relative amounts of cancellous bone formation adjacent to the prostheses. Woven trabecular bone was present at each host bone to implant perimeter interface at 3 weeks, with fine fibrous capsular formation around the implants. Thicker, lamellar trabeculae were present at 6 weeks with an increased fibrous layer surrounding both types of implants. Bone formed on the superficial and deep implant surfaces in a noncontiguous fashion. Two of five measures showed that total bone formation was significantly greater in the PLGA-coated implants. Polymethylmethacrylate discs coated with bone marrow-impregnated PLGA foam demonstrate increased bone formation at 3 and 6 weeks as compared with non-coated preformed polymethylmethacrylate discs. Only implants with preserved periosteum showed bone formation away from the host-implant interface (centrally) on the superficial surface at 6 weeks.