Safety and Clinical Performance Assessment of Bone Substitutes for Bone Void Filling A Post-Market Clinical Follow-Up Study

What this Trial Is About

This research aims to collect clinical data on the safety and performance of a range of TEKNIMED bone substitute products, including CERAFORM, TRIHA+, NANOGEL, and their private labels. These synthetic bone substitutes have been used for over 20 years and are designed to fill bone voids in various surgical or traumatic bone defects. The study is a global, single-arm, non-controlled, multicenter observational study that follows patients according to the local standard medical care at each site. Participants will receive bone substitutes during surgeries such as bone grafting, spinal fusion, and cage filling. These products are bioresorbable and gradually replaced by natural bone during healing. The study includes both retrospective and prospective data collection, with the retrospective group having undergone surgery since January 1, 2015, and the prospective group being considered for surgery using these bone substitutes. The aim is to assess real-life safety and performance in current clinical practice. During the study, participants will be monitored through standard medical care visits up to 24 months to evaluate successful bone repair. Researchers will assess outcomes including pain relief, bone reconstruction, patient well-being, and satisfaction. Data collection involves clinical follow-ups and observations without additional procedures beyond routine care. The study extends until September 2032, ensuring long-term safety and effectiveness data in real-world settings.

Bone Substitutes Outcomes - Post Market Follow-up