Evaluation of AdvanCore Bone Graft for Bone Healing
Study on Safety and Performance of AdvanCore Bone Void Filler
This study is testing if the AdvanCore bone graft can help adults with serious bone defects heal better over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artur Salgado SA Industry-sponsored |
| Locations | 4 sites (Guimarães, Braga District and 3 other locations) |
| Trial ID | NCT06736457 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the AdvanCore bone graft, a porous beta-tricalcium phosphate device, over a 12-month follow-up period. It is designed for adult patients with bone defects that exceed the body's natural healing capabilities, and it will be conducted in a multi-center, open-label format across various European sites. Participants will receive the AdvanCore graft, which acts as a temporary scaffold to aid in bone regeneration, and will be monitored for outcomes related to safety and effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a bone grafting procedure for non-healing bone lesions.
Not a fit: Patients with infections at the graft site or those who are hypersensitive to any components of AdvanCore may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve bone healing outcomes for patients with significant bone defects.
How similar studies have performed: Other studies involving beta-tricalcium phosphate bone grafts have shown promising results, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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 plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
Where this trial is running
Guimarães, Braga District and 3 other locations
- Unidade Local de Saúde do Alto Ave — Guimarães, Braga District, Portugal (Recruiting)
- Unidade Local de Saúde de São João — Porto, Porto District, Portugal (Not_yet_recruiting)
- Unidade Local de Saúde do Médio Tejo — Tomar, Santarém District, Portugal (Not_yet_recruiting)
- Unidade Local de Saúde de Trás-os-Montes e Alto Douro — Lordelo, Vila Real District, Portugal (Recruiting)
Study contacts
- Study coordinator: Francisca C Costa
- Email: f.costa@artursalgado.pt
- Phone: +351253794649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.