BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

CONMED

Status: Invitation-only

Conditions: ACL Tears

Treatments: Procedure: Arthroscopic anterior cruciate ligament reconstruction; Device: Anterior cruciate ligament reconstruction with BioBrace® augmentation

Study type: Observational

Funder types: Industry

Identifiers

NCT06948591

CSP-BB0004

Details and patient eligibility

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

BioBrace Augment Group

Description:

An anterior cruciate ligament reconstruction is performed and BioBrace is used to augment the tissue graft.

Treatment:

Device: Anterior cruciate ligament reconstruction with BioBrace® augmentation

Procedure: Arthroscopic anterior cruciate ligament reconstruction