Vitamin E-doped total hip arthroplasty liners show similar head penetration to highly cross-linked polyethylene at five years: a multi-arm randomized controlled trial

Abstract

Aims The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm). Methods Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months. Results Of 220 screened patients, 127 were included in this study. In all, 116 received the allocated intervention, and 94 had their results analyzed at five years. Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% confidence interval (CI) -0.173 to 0.005; p = 0.064), and 32 mm versus 36 mm was -0.020 mm (95% CI -0.110 to 0.071; p = 0.671), respectively. No differences were found in acetabular component migration or in the patient-reported outcome measures. Conclusion No significant difference in head penetration was found at five years between vE-PE and XLPE liners, nor between 32 mm and 36 mm heads. Cite this article: Bone Joint J 2020;102-B(10):1303–1310.

Vitamin E infused highly cross-linked cemented cups in total hip arthroplasty show good wear pattern and stabilize satisfactorily: a randomized, controlled RSA trial with 5-year follow-up

“…In the same review article, the authors proposed that an even safer threshold of 0.05 mm/year would eliminate osteolysis and the VEPE cup fulfills this requirement as well. These results are consistent with the previously published data on VEPE in uncemented cups (7,8,18,19).…”

Model-Based Roentgen Stereophotogrammetric Analysis Using Elementary Geometrical Shape Models: Reliability of Migration Measurements for an Anatomically Shaped Femoral Stem Component

“…A uniplanar RSA set up was used. This presents the common set up for hip implant migration measurement [34][35][36]. The results of this study showed the reliability of out-of-plane migration measurements was inferior to in-plane migration measurements, which can be a common limitation of the uniplanar calibration set up [14].…”

Vitamin E-Enhanced Liners in Primary Total Hip Arthroplasty: A Systematic Review and Meta-Analysis

“…From the remaining 56 studies, the reviewers excluded abstracts, reviews, protocols, and animal studies based on the inclusion and exclusion criteria. Finally, 14 studies were included, containing 11 RCTs and 3 case-control studies [16][17][18][19][20][21][22][23][24][25][26][27][28][29]. The flowchart is shown in Figure 1.…”

“…The flowchart is shown in Figure 1. [17,[19][20][21]25], two studies [16,27] used sealed hidden envelopes for allocation but did not mention specific blinding, and four studies used computer randomized allocation. Study bias was low in these RCTs [22][23][24]26].…”