Status:
RECRUITING
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
Lead Sponsor:
CONMED Corporation
Conditions:
ACL Tears
Eligibility:
All Genders
14-70 years
Brief Summary
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) reco...
Detailed Description
This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting t...
Eligibility Criteria
Inclusion
- Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
- Between 14 and 70 years old at the time of surgery.
- Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
- Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
- If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:
- International Knee Documentation Committee (IKDC)
- Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
- Patient-Reported Outcomes Measurement Information System (PROMIS-10)
- Tegner Activity Scale (TAS)
- Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
- Positive diagnostic imaging by MRI at baseline indicating an ACL tear
Exclusion
- Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
- Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
- Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
- Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06948591
Start Date
April 8 2025
End Date
June 1 2030
Last Update
November 26 2025
Active Locations (1)
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1
ConMed
New Haven, Connecticut, United States, 06513