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Recruiting NCT06948591

BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

— Observational ACL Tears

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction.
Who it may be relevant to
Registry conditions: ACL Tears. Basic parameters: 14 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Anterior cruciate ligament reconstruction with BioBrace® augmentation
    An arthroscopic anterior cruciate ligament reconstruction (ACLR) will be performed and the tissue graft will be augmented with the BioBrace® Reinforced Implant. BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA). When used in ACLRs, it is sutured alongside the tissue graft to augment and reinforce the graf
  • Procedure Arthroscopic anterior cruciate ligament reconstruction
    An arthroscopic anterior cruciate ligament reconstruction is performed using standard surgical procedure.

Primary outcome measures

  • Improvement in Function [Time frame: 3 years post-op]
  • Adverse Events [Time frame: Baseline, 6-months, 1-, 2-, and 3-years post-op]
Secondary outcome measures (7)
  • International Knee Documentation Committee (IKDC) [Time frame: Baseline, 6 months, 1-, 2-years post-op]
  • Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.) [Time frame: Baseline, 6 months, 1-, 2-, and 3-years post-op]
  • Patient-Reported Outcomes Measurement Information System (PROMIS-10) [Time frame: Baseline, 6 months, 1-, 2-, and 3-years post-op]
  • Tegner Activity Scale (TAS) [Time frame: Baseline, 6 months, 1-, 2-, and 3-years post-op]
  • Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI) [Time frame: 6 months, 1-, 2-, and 3-years post-op]
  • Secondary Surgical Intervention(s) [Time frame: 6 months, 1-, 2-, and 3-years post-op]
  • Re-tear Rate [Time frame: 6 months, 1-, 2-, and 3-years post-op]

Eligibility criteria

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)
  • Tegner Activity Scale (TAS)
  • Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
  • Positive diagnostic imaging by MRI at baseline indicating an ACL tear

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.
  • 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.
  • Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
  • Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • ConMed — New Haven

Identifiers

NCT: NCT06948591 · CSP-BB0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗