Coutances

Researchers are evaluating the safety and performance of Teknimed's arthroplasty products, including CEMFIX e and GENTAFIX e bone cements and the CEMSTOP e cement restrictor, which have been used for over 20 years. These products are designed to help fix joint prostheses to bones during joint replacement surgeries, which commonly address conditions like osteoarthritis, osteonecrosis, and trauma. The study focuses on collecting real-life long-term safety and effectiveness data through a retrospective and prospective observational design. The study involves patients undergoing cemented joint arthroplasty procedures using Teknimed's bone cements and cement restrictor. It is a global, multicenter, single-arm, non-controlled study where participants will be followed according to local medical care standards. Both patients who have already had surgery with these products since January 2016 and those scheduled for such procedures are included. Participants will be monitored for up to 15 years, with primary outcomes including survival rate of the device and rates of superficial or deep postoperative infections. Data collection includes clinical follow-up visits and routine medical care assessments. The study aims to confirm the long-term safety and performance of Teknimed arthroplasty products in real-world use.