BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

April 13, 2026 updated by: CONMED Corporation

Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Community surrounding participating hospitals / clinics.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Procedure: Arthroscopic anterior cruciate ligament reconstruction
An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC)
Time Frame: Baseline, 6 months, 1-, 2-years post-op
Patient-reported functional and activity status as assessed by International Knee Documentation Committee (IKDC)
Baseline, 6 months, 1-, 2-years post-op
Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
Time Frame: 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.)
Baseline, 6 months, 1-, 2-, and 3-years post-op
Patient-Reported Outcomes Measurement Information System (PROMIS-10)
Time Frame: 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)
Baseline, 6 months, 1-, 2-, and 3-years post-op
Tegner Activity Scale (TAS)
Time Frame: Baseline, 6 months, 1-, 2-, and 3-years post-op
Patient-reported functional and activity status as assessed by: Tegner Activity Scale (TAS).
Baseline, 6 months, 1-, 2-, and 3-years post-op
Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
Time Frame: 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)
6 months, 1-, 2-, and 3-years post-op
Secondary Surgical Intervention(s)
Time Frame: 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.
6 months, 1-, 2-, and 3-years post-op
Re-tear Rate
Time Frame: 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.
6 months, 1-, 2-, and 3-years post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CONMED Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2025

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-BB0004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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