Study on Safety and Performance of AdvanCore Bone Void Filler
Recruiting now · Not applicable
Conditions studied: Bone Fractures, Bone Defects, Bone Loss, Bone Graft
In brief
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.
Key facts
- Study ID
- NCT06736457
- Run by
- Artur Salgado SA
- People needed
- 190
- Starts
- 2025-05-29
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Where it is running
- Unidade Local de Saúde do Alto Ave — Guimarães, Braga District, Portugal (enrolling)
- Unidade Local de Saúde de Trás-os-Montes e Alto Douro — Lordelo, Vila Real District, Portugal (enrolling)
- Unidade Local de Saúde de São João — Porto, Porto District, Portugal
- Unidade Local de Saúde do Médio Tejo — Tomar, Santarém District, Portugal
Full record on ClinicalTrials.gov
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