RecruitingNot Applicable

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

United States500 participantsStarted 2025-04-08

Plain-language 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.

Who can participate

Age range

14 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in Function

Timeframe: 3 years post-op

Adverse Events

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

Trial details

NCT IDNCT06948591

SponsorCONMED Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-06

Contact for this trial

Kelley Grynewicz

7274574955 ClinicalAffairs@conmed.com

View on ClinicalTrials.gov More ACL Tears trials