Study on Safety and Performance of AdvanCore Bone Void Filler
The objective of this study is to evaluate the safety and performance of AdvanCore implantable bone graft through a 12-month follow-up period in a prospective, parallel-group design, non-controlled, open label, multi-center and real-world setting study. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.
• Adult subjects ≥ 18 years old, male or female.
• Subjects who are eligible for a bone grafting/bone void filler procedure.
• Subjects with bone lesions beyond the limits of the bone's self-healing ability.
• Subjects, and/or an authorized representative, who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center.
• Subjects with only one fracture susceptible to treatment with an AdvanCore implant.