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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AdvanCore bone grafting
Procedure/SurgeryAdvanCore medical device is implanted making sure that is in direct contact with all surfaces of the defect area.
Treatment groups
190 Participants
are divided into 3 treatment groupsGroup A: Long-bone injuriesExperimental treatment 1 intervention
Group B: Spine injuriesExperimental treatment 1 intervention
Group C: Maxillofacial injuriesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom of bone reintervention (safety)
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.
Time frame
6 months post-surgery2
Successful osteointegration (performance)
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.
Time frame
6 months post-surgerySecondary outcomes
1
Evaluation of Adverse Events or Serious Adverse Events [(S)AEs] related to the procedure (safety)
Record of Adverse Events or Serious Adverse Events \[(S)AEs\] related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Time frame
30-days post-surgery2
Evaluation of (S)AEs related to the procedure (safety)
Record of (S)AEs related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Time frame
3 months post-surgery3
Evaluation of (S)AEs related to the procedure (safety)
Record of (S)AEs related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Time frame
6 months post-surgery4
Evaluation of (S)AEs related to the procedure (safety)
Record of (S)AEs related to the procedure during a 12-month follow-up period. In all cases, the analysis population will be the Per-Protocol population, and results will be presented as the incidence (in percentage) of (S)AEs, with a 95% confidence.
Time frame
12 months post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Artur Salgado SA
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov