Di-cumyl peroxide cross-linked UHMWPE/vitamin-E blend for total joint arthroplasty implants.

Majority of ultrahigh molecular weight polyethylene (UHMWPE) medical devices used in total joint arthroplasty are cross-linked using gamma radiation to improve wear resistance. Alternative methods of cross-linking are urgently needed to replace gamma radiation due to rapid decline in its supply. Peroxide cross-linking is a candidate method with widespread industrial applications. Oxidative stability and biocompatibility, which are critical requirements for medical device applications, can be achieved using vitamin-E as an additive and by removing peroxide by-products through high-temperature melting, respectively. We investigated compression molded UHMWPE/vitamin-E/di-cumyl peroxide blends followed by high-temperature melting in inert gas as a material candidate for tibial knee inserts. Wear resistance increased and mechanical properties remained largely unchanged. Oxidation induction time was higher than most of the other clinically available formulations. The material passed the local-end point biocompatibility tests per ISO 10993. Compounds found in exhaustive extraction were of no concern with margin-of-safety values well above the accepted level, indicating a desirable toxicological risk profile. Statement of Clinical Significance: Peroxide cross-linked, vitamin-E stabilized, and high-temperature melted UHMWPE has recently been cleared for clinical use in tibial knee inserts. With all the salient characteristics needed in a material that can provide superior long-term performance in total joint patients, peroxide cross-linking can replace the gamma radiation cross-linking of UHMWPE.

Knee simulator wear of vitamin E stabilized irradiated ultrahigh molecular weight polyethylene.

Wear and damage of ultrahigh molecular weight polyethylene (UHMWPE) tibial inserts used in total knee arthroplasty are accelerated by oxidation. Radiation crosslinking reduces wear but produces residual free radicals adversely affecting stability. One alternative to stabilize radiation-crosslinked UHMWPE is to infuse the material with vitamin E (vit E). We investigated the properties of 100-kGy e-beam-irradiated UHMWPE that was subsequently doped with vitamin E in comparison with conventional UHMWPE. Both polymers were sterilized with gamma irradiation in vacuum packaging. Vitamin E-doped UHMWPE showed lower wear before and after aging (2.4 ± 0.5 and 2.5 ± 0.8 mg/million cycle, respectively, vs 26.9 ± 3.5 and 40.8 ± 3.0 mg/million cycle for conventional UHMWPE). Conventional UHMWPE showed oxidation after accelerated aging, and its mechanical properties were adversely affected, whereas vit E-doped UHMWPE showed no oxidation or changes in its mechanical properties. Vitamin E stabilization of radiation-crosslinked UHMWPE resulted in low wear and high oxidation resistance; it is an alternative load-bearing material for total knee applications.

Ex vivo stability loss of irradiated and melted ultra-high molecular weight polyethylene.

BACKGROUND: Radiation crosslinking reduces wear of ultra-high molecular weight polyethylene (UHMWPE), and subsequent annealing or melting increases oxidative stability. Little is known about the oxidative stability of polyethylene total joint components after in vivo service and subsequent shelf storage in air. METHODS: We analyzed thirty-four surgically retrieved, radiation crosslinked acetabular liners to determine their oxidative stability after in vivo service (range, 0.5 to 84.0 months). Oxidation was determined at the time of explantation. After shelf storage in air (range, 7.0 to 72.0 months), oxidation, crosslink density, and thermal properties were determined. Oxidation of one control liner that was shelf-aged in air (for eighty-four months) was also determined. RESULTS: At the time of explantation, all components showed minimal oxidation; however, oxidation levels increased during shelf storage, with a concomitant decrease in crosslink density and increase in crystallinity. Increasing oxidation, increasing crystallinity, and decreasing crosslink density correlated with the duration of ex vivo storage. The shelf-aged control liner showed no detectable oxidation. CONCLUSIONS: The oxidation and loss of crosslink density of the irradiated and melted UHMWPE was surprising. Two potential mechanisms that might alter the oxidative stability of UHMWPE in vivo are cyclic loading and absorption of lipids. Both of these mechanisms can generate new free radicals in UHMWPE and can initiate and propagate its oxidation.

A surface crosslinked UHMWPE stabilized by vitamin E with low wear and high fatigue strength.

Wear particle-induced periprosthetic osteolysis has been a clinical problem driving the development of wear resistant ultrahigh molecular weight polyethylene (UHMWPE) for total joint replacement. Radiation crosslinking has been used to decrease wear through decreased plastic deformation; but crosslinking also reduces mechanical properties including fatigue resistance, a major factor limiting the longevity of joint implants. Reducing UHMWPE wear with minimal detriment to mechanical properties is an unaddressed need for articular bearing surface development. Here we report a novel approach to achieve this by limiting crosslinking to the articular surface. The antioxidant vitamin E reduces crosslinking efficiency in UHMWPE during irradiation with increasing concentration, thus we propose to spatially control the crosslink density distribution by controlling the vitamin E concentration profile. Surface crosslinking UHMWPE prepared using this approach had high wear resistance and decreased crosslinking in the bulk resulting in high fatigue crack propagation resistance. The interface region did not represent a weakness in the material due to the gradual change in the crosslink density. Such an implant has the potential of decreasing risk of fatigue fracture of total joint implants as well as expanding the use of UHMWPE to younger and more active patients.

Delamination and adhesive wear behavior of alpha-tocopherol-stabilized irradiated ultrahigh-molecular-weight polyethylene.

Wear and delamination of conventional ultrahigh-molecular-weight polyethylene (UHMWPE) components used in total knee arthroplasty can compromise long-term performance. Radiation cross-linking and melt-annealing reduced wear and increased delamination resistance of UHMWPE. An alternative material is the alpha-tocopherol-stabilized irradiated UHMWPE (alphaTPE), with improved mechanical and fatigue properties vs irradiated and melted UHMWPE. We studied the wear and delamination resistance of alphaTPE and conventional UHMWPE (direct compression molded GUR 1050 and Himont 1900) under reciprocating unidirectional motion. Wear resistance was improved, and no delamination was observed in alphaTPE. Accelerated aging did not alter the wear and delamination behavior of alphaTPE. The GUR 1050 UHMWPE showed delamination and pitting when subjected to unidirectional reciprocating motion after accelerated aging. Himont 1900 UHMWPE showed no delamination when subjected to unidirectional reciprocating motion after accelerated aging. alpha-Tocopherol-stabilized irradiated UHMWPE is advanced for use in total knee arthroplasty due to its high resistance to wear, delamination, and oxidation.