BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

• Conditions: ACL Tears

• Registration Number: NCT06948591
• Lead Sponsor: CONMED Corporation

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) reconstruction.

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 the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-08
• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Primary Completion: 2030-06
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Function	3 years post-op	Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.
Adverse Events	Baseline, 6-months, 1-, 2-, and 3-years post-op	Evaluation of device-related adverse events

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)	Baseline, 6 months, 1-, 2-, and 3-years post-op	Patient-reported functional and activity status as assessed by the following: Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
Patient-Reported Outcomes Measurement Information System (PROMIS-10)	Baseline, 6 months, 1-, 2-, and 3-years post-op	Patient-reported functional and activity status as assessed by the following: Patient-Reported Outcomes Measurement Information System (PROMIS-10)
Tegner Activity Scale (TAS)	Baseline, 6 months, 1-, 2-, and 3-years post-op	Patient-reported functional and activity status as assessed by: Tegner Activity Scale (TAS).
Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)	6 months, 1-, 2-, and 3-years post-op	Patient-reported functional and activity status as assessed by the following: Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
Secondary Surgical Intervention(s)	6 months, 1-, 2-, and 3-years post-op	The percentage of subjects who required additional surgical procedures following discharge from the BioBrace ACLR index procedure will be reported.
Re-tear Rate	6 months, 1-, 2-, and 3-years post-op	Re-tear rate of the surgically reconstructed ACL tissue graft augmented with BioBrace. The percentage of subjects who experienced a re-tear of the augmented ACL tissue graft will be reported.
International Knee Documentation Committee (IKDC)	Baseline, 6 months, 1-, 2-years post-op	Patient-reported functional and activity status as assessed by International Knee Documentation Committee (IKDC)

Trial Locations

Locations (1)

ConMed; 🇺🇸 New Haven, Connecticut, United States