Puilboreau

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.

This research aims to assess the long-term performance and safety of ATF Implants and Lapé Médical devices used in hip replacement surgeries, including total hip arthroplasty or hemiarthroplasty. It is a prospective, observational, multicenter study designed to collect clinical evidence over a 10-year period. The study focuses on patients receiving these specific hip prostheses to better understand their durability and safety outcomes. The study involves patients undergoing hip replacement surgery with implants manufactured by ATF Implants and Lapé Médical. Surgeons will select the most appropriate prosthesis based on individual patient factors and device instructions at the time of surgery. The evaluation includes monitoring both the hip prostheses and the surgical instruments used for their placement throughout the 10-year follow-up. Participants will be followed before and after surgery with regular evaluations by surgeon-investigators using established orthopedic criteria. Data on complications, adverse effects, and prosthesis performance will be recorded. The main outcome measured is the long-term survival rate of the implants over 10 years. Additional assessments will include safety, performance, and user feedback on the devices and instruments during the study period.