Post-market Follow-up Study on Safety and Performance of TEKNIMED Bone Cements and Cement Restrictor Used in Joint Replacement Surgery

What this Trial Is About

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.

Arthroplasty Cements Outcomes - A Post-market Follow-up