BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Recruiting now

Conditions studied: ACL Tears

In brief

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.

Key facts

Study ID

NCT06948591

Run by

CONMED Corporation

People needed

500

Starts

2025-04-08

Expected to finish

2030-06-01

Last updated by the study team

2026-04-14

Who can join

Age: 14 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• ConMed — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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