Evaluation of AdvanCore Bone Graft for Bone Healing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Unidade Local de Saúde do Alto Ave
  Guimarães, Braga District, Portugal Recruiting
• Unidade Local de Saúde de Trás-os-Montes e Alto Douro
  Lordelo, Vila Real 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

Study contacts

• Study coordinator: Francisca C Costa
• Email: f.costa@artursalgado.pt
• Phone: +351253794649

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.