Comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study

This report has been verified by one or more authors of the original publication.

185 patients undergoing primary total hip arthroplasty (THA) were included in this randomized controlled trial. Patients were randomized to receive either a large femoral head metal-on-metal THA or a conventional prosthesis. The purpose of the study was to compare clinical outcomes, dislocation and metal ion release at 2 years postoperatively. Enrollment in this study did not meet the pre-planned sample size of 330 patients. The results from the 185 included patients displayed comparable clinical outcomes at 2 years between groups and lower cobalt ion concentrations at 2 years in the large femoral head THA group. No signs of osteolysis and loosening were observed and 1 dislocation in the conventional THA group was observed. The results from this trial should be interpreted with caution due to the inability to meet the pre-planned sample size calculation.