Study on Safety and Performance of Pyrocarbon Hand and Wrist Implants Collecting Long-Term Outcomes and Complications in Orthopedics

What this Trial Is About

Researchers are conducting an international post-market clinical follow-up study to collect safety and performance data on commercially available Pyrocarbon hand and wrist implants. The study aims to gather information on clinical complications and outcomes related to these implants in real-world use, satisfying post-market surveillance and regulatory requirements. This multicenter observational study collects data before surgery, during surgery, and at multiple follow-up points approximately 2 years, 5 years, and 10 years after the procedure. It focuses on patients treated with sponsor-approved Pyrocarbon implants for hand or wrist arthroplasty, including both primary and revision surgeries. Participants will be assessed using various clinical measurements such as the QuickDASH score, Patient Satisfaction scores, implant survivorship, and safety evaluations over a period up to 10 years. Data collection includes clinical assessments of strength, mobility, and wrist function changes from baseline. This long-term follow-up helps monitor implant performance and participant well-being.

Hand & Wrist Pyrocarbon Implants Outcomes Clinical Study