RESUMEN
BACKGROUND: Published analyses of never-irradiated, ethylene oxide (EtO)-sterilized tibial inserts and EtO- and gas plasma (GP)-sterilized acetabular ultra-high molecular weight polyethylene (UHMWPE) retrievals demonstrated minimal UHMWPE in vivo oxidation, whereas another analysis of EtO-sterilized acetabular liners found elevated oxidation linked with in vivo stresses. This study explored whether never-irradiated UHMWPE bearings are (1) oxidized by the in vivo environment, and (2) more likely to oxidize in higher-stress articulations (knee, ankle, shoulder). METHODS: An institutional review board-approved retrieval archive was queried for never-irradiated, EtO- and GP-sterilized UHMWPE bearings received at revision from 2001 to 2021. A total of 193 EtO-sterilized and 112 GP-sterilized conventional UHMWPE retrievals were analyzed (0 to 25 years in vivo; 133 hip, 144 knee, 18 ankle, and 10 shoulder). Retrieved implants were evaluated for in vivo damage and analyzed for trans-vinylene and ketone content by Fourier transform infrared spectroscopy (FTIR). Twelve never-implanted EtO-sterilized tibial knee inserts, (shelf-aged 5 to 19 years) were non-oxidized controls. Mechanical properties of 3 never-implanted and 3 retrieved tibial inserts were evaluated by ASTM Type-V uniaxial tensile testing. Statistical analyses evaluated correlations between time in vivo and oxidation, and compared mean oxidation rates by articulation. RESULTS: Burnishing was the most common clinical damage for all articulations. Eight retrievals exhibited oxidation-related fatigue damage. All retrievals were validated as never-irradiated (median trans-vinylene index [TVI] = 0.000). Maximum ketone oxidation in retrievals correlated with in vivo time (p < 0.001). Thirty-seven percent of retrievals exhibited UHMWPE (subsurface) oxidation, most frequently ankle, knee, and glenoid inserts. Tensile properties differed between retrieved and never-implanted inserts, changing with oxidation. The oxidation rate differed significantly among the articulations (p < 0.001). CONCLUSIONS: This study cohort confirmed the presence of in vivo oxidation in some non-irradiation-sterilized UHMWPE bearings, with higher-stress articulations (knee, ankle, shoulder) showing evidence of oxidation more frequently and having significantly higher oxidation rates than hips. Mechanical properties degraded by oxidation led to fatigue damage in 8 retrievals after a long duration in vivo. CLINICAL RELEVANCE: Conventional EtO- or GP-sterilized UHMWPE bearings are at minimal risk for fatigue damage secondary to oxidation. However, higher stresses and longer time in vivo (more cycles of use) can lead to increased wear, oxidation, and fatigue damage.
