Actively Recruiting
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
Led by CONMED Corporation · Updated on 2026-04-14
500
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
CONDITIONS
Official Title
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Underwent or scheduled for ACL reconstruction with a tissue graft augmented with BioBrace4 within 24 months
- Between 14 and 70 years old at the time of surgery
- Able to understand and consent to study information
- Willing and able to participate in prospective data collection
- If already had surgery, must have at least two specific baseline and 1-year outcome measures
- Positive MRI diagnosis of an ACL tear at baseline
You will not qualify if you...
- Other medical conditions that may prevent participation
- Currently in or planning investigational therapy within 30 days before or 3 years after study
- Underwent or scheduled for multi-ligament reconstruction (except non-operative MCL tears)
- Pregnant or breastfeeding females of child-bearing potential at time of surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ConMed
New Haven, Connecticut, United States, 06513
Actively Recruiting
Research Team
K
Kelley Grynewicz
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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