6-year follow-up on migration outcomes: a randomised clinical trial of cemented vitamin E-stabilised highly crosslinked versus standard polyethylene cup in total hip arthroplasty

Abstract

Background:In a previous study we have shown that a cemented vitamin E-doped highly cross-linked polyethylene (VEPE) compared to a conventional polyethylene cup in total hip arthroplasty (THA) has a slightly higher proximal migration but significantly lower wear rates up to 2 years after surgery. In this follow-up study we investigated the same cohort at 6 years.Methods:This was a double-blinded, non-inferiority, randomised controlled trial on patients with osteoarthritis, with a mean age of 66 years. Patients were randomly assigned to receive either the conventional polyethylene cup or the VEPE cup in a 1:1 ratio. The primary endpoint was proximal implant migration of the cup measured with radiostereometric analysis (RSA). Secondary endpoints included wear rate of the cup and patient-reported outcome measurements (PROM).Results:At the 6-year follow-up, 25 patients (11 controls, 14 VEPE) were available for RSA measurements, and we found no statistically significant difference in proximal migration between the VEPE and control groups. The wear rate was significantly lower in the VEPE group compared to controls, 0.03 mm/year and 0.07 mm/year, respectively with a mean difference 0.04 mm, (95% CI, 0.02–0.06 mm). There were no cup revisions and no difference in PROM between the groups.Conclusions:Based on our 6-year results, the VEPE group exhibited no statistical or clinically relevant difference compared to the control group, and the wear rate was significantly lower in the VEPE group. The use of a cemented vitamin E-doped highly cross-linked cup is a good option in total hip arthroplasty.