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RecruitingNot ApplicableNCT06736457

Study on Safety and Performance of AdvanCore Bone Void Filler

Sponsor

Artur Salgado SA

Enrollment

190 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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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Interventions

PROCEDUREAdvanCore bone grafting

AdvanCore medical device is implanted making sure that is in direct contact with all surfaces of the defect area.

Locations(4)

Unidade Local de Saúde do Alto Ave

Guimarães, Braga District, Portugal

Unidade Local de Saúde de São João

Porto, Porto District, Portugal

Unidade Local de Saúde do Médio Tejo

Tomar, Santarém District, Portugal

Unidade Local de Saúde de Trás-os-Montes e Alto Douro

Lordelo, Vila Real District, Portugal

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NCT06736457