The Use of Large Metal Heads in Thin Vitamin E–Doped Cross-Linked Polyethylene Inserts Does Not Increase Polyethylene Wear in Total Hip Arthroplasty: 5-Year Results From a Randomized Controlled Trial

Background: Vitamin E–doped cross-linked polyethylene (VEPE) has encouraged the use of larger heads in thinner liners in total hip arthroplasty (THA). However, there are concerns about wear and mechanical failure of the thin liner, especially when metal heads are used. The aim of this randomized controlled trial was to investigate if the use of a large metal head in thin VEPE liner would increase polyethylene wear compared with a standard 32-mm metal head and to compare periacetabular radiolucencies and patient-reported outcomes in THA. Methods: There were 96 candidates for uncemented THA who were randomly allocated to either the largest possible metal head (36 to 44 mm) that could be fitted in the thinnest available VEPE liner (intervention group) or a standard 32-mm metal head (control group). The primary outcome was proximal head penetration, measured with a model-based radiostereometric analysis. Secondary outcomes were periacetabular radiolucencies and patient-reported outcomes. The midterm results of the trial at 5 years are presented. Results: The median total proximal head penetration (interquartile range) was −0.04 mm (−0.12 to 0.02) in the intervention group and −0.03 mm (−0.14 to 0.05) in the control group (P = .691). The rates of periacetabular radiolucencies were 1 of 44 and 4 of 42 (P = .197), respectively. Patient-reported hip function and health-related quality of life did not differ between the groups, but participants in the intervention group reported a higher level of activity (median University of California Level of Activity score 7 versus 6, P = .020). There were 5 revisions caused by dislocations (2), periprosthetic fracture (1), stem subsidence (1), or iliopsoas impingement (1). Conclusions: Large metal heads in thin VEPE liners did not increase liner wear and were not associated with liner failure 5 years after THA.