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Our hypothesis was that cross-linked UHMWPE stabilized with vitamin-E would be wear and fatigue resistant. Acetabular liners were radiation cross-linked, doped with vitamin E and γ-sterilized. Hip simulator wear rate of vitamin E-stabilized UHMWPE was approximately 1 and 6 mg/million-cycles in clean serum and in serum with third-body bone cement particles, respectively; a four to ten-fold decrease from that of conventional UHMWPE. The ultimate strength, yield strength, elongation-atbreak and fatigue resistance of vitamin E-stabilized UHMWPE were significantly higher than that of 100-kGy irradiated and melted UHMWPE and were unaffected by accelerated aging. Rim impingement testing with 3.7 mm-thick acetabular liners up to 2 million-cycles showed no significant damage of the cross-linked liners compared to conventional, gamma-sterilized in inert UHMWPE vitamin-E stabilized liners. The data indicate good wear properties and improved mechanical and fatigue properties for vitamin-E stabilized cross-linked UHMWPE.

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Adhesive/abrasive wear in ultra-high molecular weight polyethylene (UHMWPE) has been minimized by radiation cross-linking. Irradiation is typically followed by melting to eliminate residual free radicals that cause oxidative embrittlement. Irradiation and subsequent melting reduce the strength and fatigue resistance of the polymer. We determined the radiation dose dependence and decoupled the effects of post-irradiation melting on the crystallinity, mechanical properties and fatigue crack propagation resistance of room temperature irradiated UHMWPE from those of irradiation alone. Stiffness and yield strength, were largely not affected by increasing radiation dose but were affected by changes in crystallinity, whereas plastic properties, ultimate tensile strength and elongation at break, were dominated at different radiation dose ranges by changes in radiation dose or crystallinity. Fatigue crack propagation resistance was shown to decrease with increase in radiation dose and with decrease in crystalline content. Morphology of fracture surfaces revealed loss of ductility with increase in radiation dose and more detrimental effects on ductility at lower radiation doses after post-irradiation melting.

Highly crosslinked UHMWPE has become the bearing surface of choice in total hip arthroplasty. First generation crosslinked UHMWPEs, clinically introduced in the 1990s, show significant improvements compared to gamma sterilised, conventional UHMWPE in decreasing wear and osteolysis. These crosslinked UHMWPEs were thermally treated (annealed or melted) after irradiation to improve their oxidation resistance. While annealing resulted in the retention of some oxidation potential, postirradiation melted UHMWPEs had reduced fatigue strength due to the crystallinity loss during melting. Thus, the stabilisation of radiation crosslinked UHMWPEs by the diffusion of the antioxidant vitamin E was developed to obtain oxidation resistance with improved fatigue strength by avoiding post-irradiation melting. A two-step process was developed to incorporate vitamin E into irradiated UHMWPE by diffusion to obtain a uniform concentration profile. Against accelerated and real-time aging in vitro, this material showed superior oxidation resistance to UHMWPEs with residual free radicals. The fatigue strength was improved compared to irradiated and melted UHMWPEs crosslinked using the same irradiation dose. Several adverse testing schemes simulating impingement showed satisfactory behaviour. Peri-prosthetic tissue reaction to vitamin E was evaluated in rabbits and any effects of vitamin E on device fixation were evaluated in a canine model, both of which showed no detrimental effects of the inclusion of vitamin E in crosslinked UHMWPE. Irradiated, vitamin E-diffused, and gamma sterilised UHMWPEs have been in clinical use in hips since 2007 and in knees since 2008. The clinical outcome of this material will be apparent from the results of prospective, randomised clinical studies. IntroductionOsteolysis triggered mainly by ultrahigh molecular weight polyethylene (UHMWPE) wear particles has been one of the major problems in total hip arthroplasty along with instability/dislocation and infection [7]. Highly crosslinked UHMWPEs were developed using high-dose irradiation (50-100 kGy) to decrease the wear rate of UHMWPE [44,46] and have become the standard-of-care after their first decade of service, especially in North America [61].Irradiation causes crosslinking in the amorphous phase of the UHMWPE [33], but also initiates the formation of free radicals in the crystalline phase [23], unable to recombine due to structural limitations, they become trapped for long periods of time [29]. These residual free radicals are believed to migrate to the crystalline/amorphous interface and cause oxidative degradation in the material [16][17][18]59, 69] through a cascade of reactions with oxygen [32,71].In first generation crosslinked UHMWPEs [34], postirradiation thermal treatment was used to increase the oxidation resistance (Fig. 1). One approach was to annealThe studies discussed here were performed by research funding in part from NIH/NIAMS

Vitamin E-stabilized, highly cross-linked ultrahigh molecular weight polyethylene (UHMWPE) is a promising oxidation and wear resistant UHMWPE with improved mechanical strength in comparison with the first generation, irradiated and melted UHMWPE. One approach of incorporating vitamin E in UHMWPE is through blending of vitamin E in UHMWPE powder followed by consolidation and radiation crosslinking. However radiation crosslinking efficiency of UHMWPE decreases in the presence of vitamin E. Therefore an optimum vitamin E concentration and radiation dose level needs to be determined to achieve a cross-link density comparable to 100-kGy irradiated and melted UHMWPE, which has shown excellent wear properties in vivo. We investigated the cross-link density and mechanical properties of vitamin E-blended UHMWPEs as a function of vitamin E concentration in the blend and gamma irradiation doses up to 200 kGy. We found that 0.3 wt% vitamin E-blended UHMWPE could not be cross-linked above a cross-link density achieved at a radiation dose of 65 kGy for virgin UHMWPE and 1.0 wt% vitamin E-blended UHMWPE could not be cross-linked above a cross-link density achieved at a radiation dose of 25 kGy for virgin UHMWPE even when the former were irradiated to a radiation dose of 200 kGy. In addition, higher plasticity at vitamin E concentrations at and above 0.3 wt% indicated that increased chain scissioning may be prevalent. Since the wear resistance of this irradiated UHMWPE would be expected to be low, vitamin E concentrations equal to or above 0.3 wt% are not recommended for subsequent irradiation to achieve a wear resistant cross-linked UHMWPE. The long-term oxidative stability of irradiated blends with low vitamin E concentrations has yet to be studied to determine an optimum between cross-link density and long-term oxidative stability.