Prospective Multicenter Study Evaluating the Performance and Stability of the SMS Uncemented Femoral Stem in Total Hip Replacement

What this Trial Is About

Researchers are evaluating the performance and stability of the SMS femoral stem implant in patients who need total hip replacement due to conditions like osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. This is a prospective, multicenter, open clinical study without randomization or control groups. The study is sponsored by Medacta International SA and aims to observe participants for up to 10 years to assess long-term outcomes. Participants will undergo Total Hip Arthroplasty using the SMS Femoral Stem by Medacta. The study will monitor the implants survival rate, clinical performance, hip function, quality of life, safety through adverse event tracking, and the implants stability and fixation over the 10-year period. There is no mention of different treatment groups or placebos, as this is an observational study focused on one specific implant procedure. During the study, participants will be regularly assessed for the durability and function of the SMS femoral stem, hip joint performance, and overall quality of life. Safety will be monitored by recording any adverse events. The total participation duration lasts from enrollment until 10 years after the procedure. Patients must comply with study requirements and provide informed consent, with ongoing follow-up to evaluate the implants long-term effects and stability.

Multicentre SMS Study - FR