NCT06736457 Study on Safety and Performance of AdvanCore Bone Void Filler
| NCT ID | NCT06736457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Artur Salgado SA |
| Condition | Bone Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-05-29 |
| Primary Completion | 2026-10 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Subjects with any AdvanCore contraindication for implantation or use. * Subjects with hypersensitivity to any of the AdvanCore components. * Subjects with infections or soft/granulation tissue in the area to place bone graft. * Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. * Women who are breastfeeding or of childbearing potential who are, or p