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
N/A
Total Duration
On this page
Sponsors
A
Artur Salgado SA
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the safety and performance of the AdvanCore implantable bone graft device in adults who need bone grafting due to bone defects caused by surgery or trauma. The study is designed as a prospective, open-label, multi-center trial in a real-world setting to meet post-market clinical follow-up requirements in Europe. It focuses on patients with bone injuries that cannot heal on their own, including long-bone, spine, and maxillofacial injuries. AdvanCore is a porous beta-tricalcium phosphate device available as blocks, wedges, or granules, which are surgically placed into bone defects. The device acts as a temporary scaffold to aid bone regeneration and must contact cancellous bone, with placement free of infection or soft tissue. The study divides participants into three groups based on injury type: long-bone injuries treated with various shapes of AdvanCore, spine injuries treated with granules, and maxillofacial injuries also treated with granules. Participants will be followed for 12 months after surgery, with evaluations at 30 days, 3, 6, and 12 months to monitor safety and device performance. Assessments include tracking adverse events related to the procedure and device, checking for bone reintervention needs, and measuring successful osteointegration and bone graft resorption. The study aims to minimize discomfort and risks, ensuring thorough safety and effectiveness monitoring throughout the follow-up period.
CONDITIONS
Brief Title
Study on Safety and Performance of AdvanCore Bone Void Filler
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects 18 years or older, male or female
- Eligible for bone grafting or bone void filler procedure
- Bone lesions beyond the bone's self-healing ability
- Willing and able to provide informed consent and participate in all study testing
- Only one fracture suitable for AdvanCore implantation
You will not qualify if you...
- Any contraindication for AdvanCore implantation or use
- Hypersensitivity to any AdvanCore components
- Infections or soft/granulation tissue at the bone graft site
- Currently enrolled in another investigational study or registry that interferes with this study
- Women who are breastfeeding or may become pregnant during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate days following
Participants undergo surgery where the AdvanCore bone void filler device is implanted to aid bone regeneration. Immediate post-operative care is provided following the procedure.
1 surgery visit and several immediate post-operative visits
Duration - Up to 12 months post-surgery
Participants are monitored to evaluate safety and performance of the AdvanCore device, including assessment of adverse events, osteointegration, and bone graft resorption.
Follow-up visits at 30 days, 3 months, 6 months, and 12 months post-surgery
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
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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