AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Recruitingn/aAges 14 Years - 70 YearsAllCONMED Corporation
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • Anterior cruciate ligament reconstruction with BioBrace® augmentation
  • Arthroscopic anterior cruciate ligament reconstruction
📍

Where

1 site
ConMed
New Haven, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy