AdvanCore bone grafting: AdvanCore medical device is implanted making sure that is in direct contact with all surfaces of the defect area.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Freedom of bone reintervention (safety) — 6 months post-surgery The primary safety endpoint is defined as freedom of bone reintervention due to AdvanCore usage at 6 months, analyzing the occurrence of (S)AEs related to the device usage and/ or AdvanCore procedure that may lead to subjects' reoperation.
Successful osteointegration (performance) — 6 months post-surgery The primary performance endpoint will analyze the AdvanCore integration at 6 months of surgery. This process is defined as osteointegration, which refers to the direct structural and functional connection of the living bone with the surface of the implant. The implant osteointegration will be assessed by imaging techniques selected according to the current clinical practices of each site. In this regard, the primary performance endpoint will be analyzed by considering the percentage of subjects with successful osteointegration at the defined timeline. AdvanCore will be considered successfully osteointegrated when the presence of fibrotic tissue surrounding the implant is not detected.
Trial sites (4)
Facility
City
Region
Status
Unidade Local de Saúde do Alto Ave
Guimarães
Braga District
Recruiting
Unidade Local de Saúde de São João
Porto
Porto District
Not Yet Recruiting
Unidade Local de Saúde do Médio Tejo
Tomar
Santarém District
Not Yet Recruiting
Unidade Local de Saúde de Trás-os-Montes e Alto Douro
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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