BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

NCT ID: NCT06948591

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-08
• Study Completion Date: 2030-06-30

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.

Conditions

ACL Tears

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

BioBrace Augment Group

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

Anterior cruciate ligament reconstruction with BioBrace® augmentation

Intervention Type: DEVICE

An arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graft construct. BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care ACL reconstruction techniques.

Arthroscopic anterior cruciate ligament reconstruction

Intervention Type: PROCEDURE

An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Interventions

Anterior cruciate ligament reconstruction with BioBrace® augmentation

An arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graft construct. BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care ACL reconstruction techniques.

Intervention Type: DEVICE

Arthroscopic anterior cruciate ligament reconstruction

An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CONMED Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ConMed

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evona Wojtanowski

Role: CONTACT

ClinicalAffairs@conmed.com

Facility Contacts

Role: primary

ClinicalAffairs@conmed.com

Other Identifiers

CSP-BB0004

Identifier Type: -

Identifier Source: org_study_id