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A randomized double-blind noninferiority trial, evaluating migration of a cemented vitamin E-stabilized highly crosslinked component compared with a standard polyethylene component in reverse hybrid total hip arthroplasty

The Bone & Joint Journal Oct 10, 2019

Sköldenberg OG, Rysinska AD, Chammout G, et al. - A total of 42 individuals (21 male, 21 female) with osteoarthritis were recruited in a double-blinded, noninferiority, randomized controlled trial and were randomized to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or vitamin E-doped, highly crosslinked polyethylene (VEPE), with identical geometry in order to assess the safety of a new cemented VEPE component, in comparison with a conventional polyethylene (PE) component concerning migration, head penetration, and clinical outcomes. At two years, this cemented VEPE component, however, with a low head penetration and superior clinical outcomes, failed to meet noninferiority, in comparison with the conventional implant by a proximal migration above the given safety threshold of radiostereometric analysis. Moreover, the early proximal migration pattern of the VEPE component was a cause for persistent monitoring, nevertheless, a specific threshold for proximal migration and risk for later failure could not be ascertained and requires further study.
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