Multi-Center Study of Emphasys Hip Devices for Treatment of Severe Hip Osteoarthritis and Related Conditions

What this Trial Is About

Researchers are evaluating the Emphasys Hip Solutions device in people who need primary total hip arthroplasty due to severe pain or disability from conditions like osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, or acute fractures. This is a prospective, multi-center study without randomization or a control group. The study aims to measure the movement of the Emphasys acetabular shell and femoral stem over the first two years after surgery and compare the results to historical data from a similar device. Participants will receive the Emphasys Hip Solutions device, which includes the Emphasys Acetabular Shell, AOX Polyethylene Liner, Articuleze 1214 metal head, and femoral stem. The study does not restrict other treatment procedures as long as the specified devices are used. The primary focus is on measuring device migration using model-based radiostereometric analysis RSA over two years, with additional measurements such as subsidence and head penetration assessed at multiple time points up to two years. During the study, participants will undergo several assessments including RSA imaging at 6 weeks, 6 months, 1 year, and 2 years post-implantation. They will also complete hip outcome questionnaires like the HOOS Jr., Harris Hip Score, and Forgotten Joint Score before surgery and at follow-up visits. Researchers will monitor device stability, hip function, and patient-reported outcomes to understand the performance of the Emphasys Hip Solutions. Participation may last at least two years to capture these long-term results.

Emphasys Radiostereometric Analysis