Evaluation of Safety and Effectiveness of AdvanCore Bone Graft Implant in Adults Needing Bone Repair

What this Trial Is About

This research aims to assess the safety and performance of the AdvanCore implantable bone graft device in adults who need bone grafting due to bone defects caused by surgery or trauma. The study is designed as a prospective, open-label, multi-center trial in a real-world setting to meet post-market clinical follow-up requirements in Europe. It focuses on patients with bone injuries that cannot heal on their own, including long-bone, spine, and maxillofacial injuries. AdvanCore is a porous beta-tricalcium phosphate device available as blocks, wedges, or granules, which are surgically placed into bone defects. The device acts as a temporary scaffold to aid bone regeneration and must contact cancellous bone, with placement free of infection or soft tissue. The study divides participants into three groups based on injury type long-bone injuries treated with various shapes of AdvanCore, spine injuries treated with granules, and maxillofacial injuries also treated with granules. Participants will be followed for 12 months after surgery, with evaluations at 30 days, 3, 6, and 12 months to monitor safety and device performance. Assessments include tracking adverse events related to the procedure and device, checking for bone reintervention needs, and measuring successful osteointegration and bone graft resorption. The study aims to minimize discomfort and risks, ensuring thorough safety and effectiveness monitoring throughout the follow-up period.

Study on Safety and Performance of AdvanCore Bone Void Filler