Actively Recruiting
Study on Safety and Performance of AdvanCore Bone Void Filler
Led by Artur Salgado SA · Updated on 2025-05-31
190
Participants Needed
4
Research Sites
70 weeks
Total Duration
On this page
Sponsors
A
Artur Salgado SA
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on Safety and Performance of AdvanCore Bone Void Filler
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects 63 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.
You will not qualify if you...
- 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).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Unidade Local de Saúde do Alto Ave
Guimarães, Braga District, Portugal, 4835-044
Actively Recruiting
2
Unidade Local de Saúde de São João
Porto, Porto District, Portugal, 4200-319
Not Yet Recruiting
3
Unidade Local de Saúde do Médio Tejo
Tomar, Santarém District, Portugal, 2304-909
Not Yet Recruiting
4
Unidade Local de Saúde de Trás-os-Montes e Alto Douro
Lordelo, Vila Real District, Portugal, 5000-508
Actively Recruiting
Research Team
F
Francisca C Costa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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