Clinical trial NCT06948591: BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
Official title: Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: ACL Tears
Keywords: ACL reconstruction
BioBrace
augmentation
Lead sponsor: CONMED Corporation
Sponsor class: INDUSTRY
First posted: 2025-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community surrounding participating hospitals / clinics.

Brief 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.

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.

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.

Primary outcomes:
measure: Improvement in Function
timeFrame: 3 years post-op
measure: Adverse Events
timeFrame: Baseline, 6-months, 1-, 2-, and 3-years post-op
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC)
timeFrame: Baseline, 6 months, 1-, 2-years post-op
measure: Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
timeFrame: Baseline, 6 months, 1-, 2-, and 3-years post-op
measure: Patient-Reported Outcomes Measurement Information System (PROMIS-10)
timeFrame: Baseline, 6 months, 1-, 2-, and 3-years post-op
measure: Tegner Activity Scale (TAS)
timeFrame: Baseline, 6 months, 1-, 2-, and 3-years post-op
measure: Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
timeFrame: 6 months, 1-, 2-, and 3-years post-op
measure: Secondary Surgical Intervention(s)
timeFrame: 6 months, 1-, 2-, and 3-years post-op
measure: Re-tear Rate
timeFrame: 6 months, 1-, 2-, and 3-years post-op
Other outcomes:
Locations:
city: New Haven
country: United States
facility: ConMed
state: Connecticut
Study officials:
References: