Abstract
Summary
Four highly cross-linked UHWMPEs except vitamin E-stabilised explants
Introduction
The development of both first and second generation highly cross-linked material focused on stabilizing radiation-induced free radicals as the sole precursor to oxidative degradation; however, secondary in vivo oxidation mechanisms have been identified in both conventional and highly cross-linked UHMWPE, induced by absorbed lipids and cyclic mechanical load. Retrieval studies are reporting in vivo oxidation highly cross-linked retrievals with up to ten year in vivo durations. Preclinical aging tests did not predict these in vivo material changes. With only a decade of these materials in clinical use, retrieval studies are limited to mid-term follow-up. In vitro studies face a challenge in effectively replicating the precise in vivo conditions that lead to this loss of oxidation resistance. In this study, we bypass replicating these in vivo variables by examining surgically-retrieved components, thereby testing material that has been affectively “pre-conditioned” by their in vivo service. After a preliminary post-operative analysis, we subjected retrievals to accelerated aging tests in order to predict the extent to which their oxidative stability had been uniquely compromised in vivo.
Patients & Methods
Twenty-four highly cross-linked retrievals of four manufacturing methods (n=6 each of Longevity™, Prolong™, X3™ and E1™) and in vivo durations (1–4 years) were analyzed post-operatively and after accelerated aging (70°C, 5atm O2 for 2 weeks; ASTM F2003). Never-implanted components (n=1) of each material type were also aged. Infrared microscopy was used to evaluate lipid absorption, oxidation (per ASTM F2102-01ε1) and hydroperoxide levels after 16 hrs of nitric oxide staining for oxidation potential, and gravimetric swelling analysis assessed cross-link density (ASTM F2214).
Results
All retrievals contained absorbed lipids penetrating below both loaded (penetration depth=1.3 ± 0.5 mm) and unloaded (0.6 ± 0.2 mm) surfaces. Each material type subset contained retrievals with and without detectable oxidation after in vivo service (Max OI=0.01–0.94). After aging, all post-irradiation thermally-treated, highly cross-linked retrievals, regardless of initial lipid levels or oxidation, showed oxidative degradation, demonstrated by subsurface oxidative peaks (MOI=0.30–2.63), increased hydroperoxides (3–5X), and decreased cross-link density (−34–90%). In contrast, vitamin E-stabilised retrievals showed below MOI<0.2 with no significant loss of cross-link density. Never-implanted controls for each material type showed no oxidative changes after accelerated aging.
Discussion/Conclusion
Accelerating aging after in vivo service has shown oxidative instability characterised by high oxidation and material property loss in the three highly cross-linked materials without an incorporated antioxidant. This oxidative degradation took place regardless of post-operative oxidation levels, indicating that even without detectable oxidation the material had undergone changes during in vivo service, as compared to the lack of oxidative response in never-implanted controls. These findings also suggest that the presence of an antioxidant may be able to slow down and/or stabilise in vivo mechanisms compromising long-term oxidative stability and increase the longevity of highly cross-linked UHMWPE materials.
