Study of Clinical and Radiological Outcomes After Hip Resurfacing Surgery Using the ROMAX System Over 10 Years

What this Trial Is About

Researchers are evaluating the safety and performance of the Medacta ROMAX hip resurfacing system in patients with hip arthritis or congenital hip dysplasia. This observational study aims to track the implants survival rate over 10 years, focusing on dislocations and wear-related effects. The trial also assesses patient-reported outcomes and the migration behavior of the device using a specialized CTMA method in a subgroup of patients. The study includes 150 patients undergoing hip resurfacing surgery with the ROMAX system. A subgroup of 40 patients will have additional CTMA analysis at 3 years after surgery. Follow-up visits are scheduled at 3 months, and then at 1, 3, 5, and 10 years post-surgery. Data collected includes clinical scores, radiological and clinical assessments before and after surgery, and details about the surgical procedure. Participants will be evaluated through clinical and radiological exams, as well as questionnaires measuring hip function and activity levels at multiple time points up to 10 years. For the CTMA subgroup, detailed imaging will assess implant migration at 3 months, 1 year, and 3 years. The primary outcome measured is implant survival at 10 years, with several secondary outcomes including various hip function scores and radiologic evaluations. The study monitors participant progress and safety during the entire follow-up period.

Clinical and Radiological Outcomes of the ROMAX Hip Resurfacing System