Study on Safety and Performance of AdvanCore Bone Void Filler
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtur Salgado SA
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AdvanCore bone grafting
Treatment groups
190 Participants
are divided into 3 treatment groupsSponsors and collaborators
Artur Salgado SA
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov