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Study on Safety and Performance of AdvanCore Bone Void Filler

RecruitingNAAges 18 Years - anyAllArtur Salgado SA
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • AdvanCore bone grafting
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Where

4 sites
Unidade Local de Saúde do Alto Ave
Guimarães, Portugal
Unidade Local de Saúde de São João
Porto, Portugal
Unidade Local de Saúde do Médio Tejo
Tomar, Portugal
Unidade Local de Saúde de Trás-os-Montes e Alto Douro
Lordelo, Portugal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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