RECRUITING

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

Conditions

ACL Tears ACL reconstruction BioBrace augmentation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-08

Study Completion:2030-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06948591

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.

Ages Eligible for Study:14 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Evona Wojtanowski

CONTACT

914-334-2498

EvonaWojtanowski@conmed.com

Study Locations (Sites)

ConMed

New Haven, Connecticut, 06513

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-04-08

Study Completion Date2030-06

Study Record Updates

Study Start Date2025-04-08

Study Completion Date2030-06

Terms related to this study

Keywords Provided by Researchers

ACL reconstruction
BioBrace
augmentation

Additional Relevant MeSH Terms

ACL Tears