Puilboreau

This research aims to assess the safety and performance of Teknimed arthroplasty products, including the CEMFIX and GENTAFIX bone cement families and the CEMSTOP cement restrictor, which have been used for more than 20 years in joint replacement surgeries. The study focuses on real-life long-term data to confirm previous findings on these products safety and effectiveness in patients undergoing joint replacement due to osteoarthritis, osteonecrosis, trauma, or revision surgeries. The study is a global, multicenter, observational trial that collects both retrospective and prospective data from patients receiving primary or revision joint replacements involving Teknimed bone cements and cement restrictors. Different groups include patients undergoing knee, hip, or shoulder surgeries with various cement types. Patients receive treatment as part of their standard medical care, without additional interventions mandated by the study. Participants will be monitored according to local medical practices, with data collected on outcomes such as implant survival, infection rates, pain levels, patient satisfaction, function restoration, complications, and adverse events. The primary outcomes cover up to 15 years, focusing on device lifetime and postoperative infections, while secondary outcomes evaluate patient-reported and clinical measures over five years. This long-term follow-up aims to provide comprehensive safety and performance information for these arthroplasty products.

Researchers are conducting an observational and prospective multicenter study to evaluate the long-term performance and safety over 10 years of ATF Implants and Lap Mdical devices used in total hip arthroplasty or hemiarthroplasty. The study aims to collect clinical evidence on the survival rate of these hip prostheses and assess their safety and performance during this period. It also seeks feedback on the surgical instruments used for implant placement. The study follows patients before and after their hip replacement surgery using implants made by ATF Implants and Lap Mdical. Surgeons evaluate patients based on standard orthopedic surgery criteria and record any complications or adverse effects observed. The main focus is on tracking the 10-year survival rate of the implants, while secondary goals include monitoring hip joint function at multiple points before surgery, and at 6 months, 2, 5, 7, and 10 years after surgery. Participants will be followed over a 10-year period with regular assessments by the surgical team. These evaluations include clinical examinations and monitoring for any complications related to the implants or surgical instruments. The study gathers detailed data on hip joint performance and safety, helping to understand how well the implants work and last over a decade. This long-term follow-up provides important information for future patients and healthcare providers.