Effectiveness of Dual-mobility Cups for Preventing Dislocation After Primary Total Hip Arthroplasty by a Posterolateral Approach and Their Cost-effectiveness Compared to Unipolar Cups in Elderly Patients.

What this Trial Is About

Researchers are evaluating whether there is a difference in the number of hip dislocations after primary total hip arthroplasty (THA) using the posterolateral approach in elderly patients aged 70 years and older. The study compares dual mobility (DM) cups and unipolar cups, focusing on dislocation rates 1 year after surgery. This prospective, multi-center, nationwide, single-blinded randomized controlled trial is nested within the Dutch Arthroplasty Register (LROI) and also examines cost-effectiveness and patient-reported outcomes. Participants are randomly assigned to receive either a cemented total hip arthroplasty with a dual mobility cup or a unipolar cup. The study includes 550 patients in each group. Both cups are cemented and used in primary THA with a 32mm or 36mm liner. The study also collects data on revisions, costs, patient physical function, pain, quality of life, and implant survival, with follow-up assessments extending up to 10 years after surgery. During the study, participants will be monitored for hip dislocations and revisions at 1 and 2 years after surgery. Patient-reported outcomes on physical function, pain, and quality of life will be collected at these times. Cost-effectiveness questionnaires will be completed at 1 year. Implant survival will be followed for 5 to 10 years. The study involves completing questionnaires in addition to standard care, with increased follow-up surveillance as part of study participation.

Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.