Tomar

Researchers are evaluating the safety and performance of the AdvanCore implantable bone graft in adults needing bone grafting due to bone defects caused by surgery or trauma. This study is a multi-center, open-label, non-controlled clinical investigation designed to meet post-market clinical follow-up requirements for the CE Mark in Europe. AdvanCore is intended for use in bone regeneration where natural healing is insufficient, targeting adult patients with mechanically unaffected, pathologic, or traumatic bone defects. The AdvanCore device is a porous beta-tricalcium phosphate product available in blocks, wedges, or granules, surgically placed into bone defects that are free from infection and soft tissue. It must contact cancellous bone and can be shaped or pressed into the defect area. AdvanCore acts as a temporary scaffold and does not provide mechanical support, so additional load-bearing therapy may be necessary. The study includes up to 190 subjects divided into three groups based on injury type: long-bone injuries (treated with blocks, wedges, or granules), spine injuries (treated with granules), and maxillofacial injuries (treated with granules). Participants will be followed for 12 months with primary outcomes measured at 6 months post-surgery, including freedom from bone reintervention and successful osteointegration without fibrotic tissue around the implant. Secondary outcomes assess adverse events related to the device and procedure, reintervention rates, osteointegration, and bone graft resorption rates. The study involves various assessments to minimize pain and discomfort, ensuring participant safety while monitoring device performance and healing progress.