BioBrace augmentation for ACL reconstruction

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

This project tests whether using the BioBrace-reinforced implant to augment tissue grafts helps people having ACL reconstruction have better mid-term safety and function.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 14 Years to 70 Years
• Sex: All
• Sponsor: CONMED Corporation (industry)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06948591 on ClinicalTrials.gov

What this trial studies

This is a multi-center, single-arm, open-label registry enrolling people who receive ACL reconstruction with a tissue graft augmented by the BioBrace® reinforced implant, enrolled either retrospectively or prospectively. Clinical data are collected at baseline (pre-op) and at 6 months, 1 year, 2 years, and 3 years after surgery. Outcomes include patient-reported measures of pain, function, return to activity, and safety events related to the procedure and implant. The registry aims to describe mid-term clinical performance and complications associated with BioBrace augmentation.

Who should consider this trial

Good fit: Ideal candidates are people aged 14–70 who have had or are scheduled to have ACL reconstruction with a tissue graft augmented by BioBrace within 24 months and who can give informed consent and comply with follow-up.

Not a fit: Patients outside the 14–70 age range, those not receiving BioBrace augmentation, or people unable to provide required baseline and follow-up data are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, BioBrace augmentation could reduce graft failure and improve pain, function, and return-to-activity outcomes after ACL reconstruction.

How similar studies have performed: Some prior small or short-term reports of graft-augmentation devices have shown promising results, but mid-term evidence specifically for BioBrace is limited.

Eligibility criteria

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.

Where this trial is running

New Haven, Connecticut

• ConMed — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Study coordinator: Kelley Grynewicz

Conditions: ACL Tears, ACL reconstruction, BioBrace, augmentation