Randomized Study Comparing Dual-Mobility and Unipolar Cups in Primary Total Hip Replacement by Direct Anterior Approach

What this Trial Is About

Researchers are comparing dual-mobility DM cups versus unipolar UP cups for people undergoing primary total hip arthroplasty THA using the direct anterior approach. THA replaces damaged bone and cartilage with prosthetic parts, and while UP cups are common, they carry risks of dislocation, especially in elderly or female patients and those with lumbar stiffness or femoral neck fractures. DM cups were designed to reduce dislocation rates by allowing more movement and stability, but concerns about complications like polyethylene wear and impingement exist. This trial aims to see if DM cups provide outcomes that are not worse than UP cups, focusing on hip joint awareness. Participants will have THA through the direct anterior approach with liners made of highly-crosslinked vitamin-E infused polyethylene and femoral heads made of metal or ceramic. Those randomized to the DM cup group will receive a cementless dual-mobility cup, while those in the UP cup group will receive a cementless unipolar cup. The femoral stem will be cemented in female patients aged 75 or older or those diagnosed with osteoporosis. The surgery involves specific muscle dissection and femoral neck osteotomy before implanting the prosthetic components and closing the surgical site. During the study, participants hip function, pain, sports and sexual activity, satisfaction, and adverse events will be assessed before surgery and at 3 months, 1 year, and 2 years after surgery. The main outcome is the forgotten joint score measured at 2 years. Researchers will monitor for complications and compare results between the two groups. The study will last until 2030, with ongoing follow-up to evaluate patient outcomes and safety.

Comparing Dual-mobility Cups Versus Unipolar Cups for Unselected Primary Total Hip Arthroplasty by Direct Anterior Approach