The Medacta SMS Femoral Stem Component A Multi-National, Multi-Centre, Clinical Surveillance Study

What this Trial Is About

Researchers are conducting a post-marketing surveillance study to evaluate the SMS femoral stem prosthesis used in patients with severely painful or disabling hip conditions such as osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. The study focuses on observing the performance and safety of this device over a long period to understand its survivorship and patient outcomes. Participants receive the SMS femoral stem as part of their primary total hip replacement surgery. This is an observational study where the device's clinical and radiographic performance will be tracked at multiple intervals including 3, 5, 7, and 10 years. Additional evaluations include bone remodeling, stem migration, patient satisfaction, quality of life, and monitoring of adverse events up to 10 years after implantation. During the study, participants will undergo regular assessments such as radiographic imaging, clinical evaluations, and questionnaires about their satisfaction and quality of life from 6 months through 10 years. Researchers will closely monitor the device's survivorship, bone remodeling patterns, and any complications to gather long-term safety and effectiveness data. The total participation duration can extend up to 10 years, allowing comprehensive long-term follow-up.

The Medacta International SMS Post-Marketing Surveillance Study