Active — Not RecruitingNot Applicable

Bridge-Enhanced ACL Repair vs ACL Reconstruction

United States100 participantsStarted 2016-04

Plain-language summary

The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.

Who can participate

Age range14 Years – 35 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 14 to 35 years of age. * Sex: Both male and female * ACL: Complete tear * Time from injury to surgery: ≤45 days * MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau Exclusion Criteria: * Prior surgery on affected knee * Prior joint infection on affected knee * Regular use of tobacco or nicotine * Use of corticosteroid within last 3 months * History of chemotherapy treatment * History of sickle cell disease * History of anaphylaxis * Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc) * Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) * Grade III medial collateral ligament injury * Complete patellar dislocation * Known allergy to bovine, beef or cow products

What they're measuring

International Knee Documentation Committee (IKDC) Subjective

Timeframe: 2 years after surgery

Instrumented Anteroposterior (AP) Laxity Testing

Timeframe: 2 years after surgery

Trial details

NCT IDNCT02664545

SponsorMiach Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-19

Results submitted2023-07-24

View on ClinicalTrials.gov More Anterior Cruciate Ligament Tear trials