BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Launched by CONMED CORPORATION · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of support called the BioBrace® Reinforced Implant, which is used to help strengthen a tissue graft during surgery to repair a torn anterior cruciate ligament (ACL) in the knee. The goal is to see how safe and effective this implant is over the mid-term period after surgery, helping patients recover better from their ACL injury.

People who may be eligible to join are those between 14 and 70 years old who either have had ACL reconstruction surgery with the BioBrace® implant within the last two years or are planning to have this surgery soon. Participants should be able to understand and agree to take part in the study, and if they already had surgery, they need to have certain knee function tests recorded before and one year after the operation. During the study, participants will be asked to share information about their knee health and overall recovery to help researchers understand how well the BioBrace® implant works. It’s important to note that people with other serious health issues, those currently in other experimental treatments, or women who are pregnant or breastfeeding at the time of surgery cannot join this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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®.
• • 2. Between 14 and 70 years old at the time of surgery.
• • 3. Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
• • 4. Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
• 5. 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:
• • 1. International Knee Documentation Committee (IKDC)
• • 2. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
• • 3. Patient-Reported Outcomes Measurement Information System (PROMIS-10)
• • 4. Tegner Activity Scale (TAS)
• • 5. Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
• • 6. Positive diagnostic imaging by MRI at baseline indicating an ACL tear
• Exclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
• • 4. Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.