BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

NCT06948591 | Recruiting FDA Device

• 1 other identifier: CSP-BB0004
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Tears

Keywords

ACL reconstruction; BioBrace; augmentation

Outcome Measures

Primary Outcomes (2)

• Improvement in Function

  Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.

  3 years post-op

• Adverse Events

  Evaluation of device-related adverse events

  Baseline, 6-months, 1-, 2-, and 3-years post-op

Secondary Outcomes (7)

• International Knee Documentation Committee (IKDC)

  Baseline, 6 months, 1-, 2-years post-op

• Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)

  Baseline, 6 months, 1-, 2-, and 3-years post-op

• Patient-Reported Outcomes Measurement Information System (PROMIS-10)

  Baseline, 6 months, 1-, 2-, and 3-years post-op

• Tegner Activity Scale (TAS)

  Baseline, 6 months, 1-, 2-, and 3-years post-op

• Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)

  6 months, 1-, 2-, and 3-years post-op

Study Arms (1)

BioBrace Augment Group

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

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

Interventions

Anterior cruciate ligament reconstruction with BioBrace® augmentation 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.

BioBrace Augment Group

Arthroscopic anterior cruciate ligament reconstruction PROCEDURE

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

BioBrace Augment Group

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community surrounding participating hospitals / clinics.

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.

Sponsors & Collaborators

• CONMED Corporation: lead

Study Sites (1)

ConMed

New Haven, Connecticut, 06513, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Kelley Grynewicz

CONTACT

7274574955; ClinicalAffairs@conmed.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 29, 2025
• Study Start: April 8, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2025-04

Locations

US (1)