Evaluating the Clinical Performance of XPEO-E Liner in SERF Dual-Mobility Hip Replacement Cups

What this Trial Is About

Researchers are evaluating the clinical performance of the XPEO-E liner used in SERF dual-mobility cups for total hip arthroplasty THA. This observational study aims to collect data to support transitioning the XPEO-E liner to meet the new Medical Device Regulation MDR 2017745 in the EU. The XPEO-E liner has CE marking under the Medical Device Directive by equivalency with the CI E liner, but no direct data on its performance is yet available. The XPEO-E liner is intended for use with NOVAE cups, SERF femoral heads, and stems as part of hip replacement surgery to improve quality of life and reduce pain caused by damaged joints. The devices will be used according to their CE markings. Follow-up visits will follow current medical practice, with additional data collected through questionnaires completed by patients and surgeons. Participants will be followed for up to 5 years after surgery. Researchers will assess functional improvement, survival rate of the implant, pain relief, quality of life, patient satisfaction, and any adverse events. The study collects information during standard operative and post-operative periods, using questionnaires and clinical evaluations to monitor outcomes and safety over time.

Clinical Performance of XPEO-E Liner in SERF Dual-mobility Cups