Bridge-Enhanced ACL Repair vs ACL Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).

Official Title
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A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)

Conditions
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Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Device: BEAR Scaffold
* Procedure: Tendon Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bridge-Enhanced ACL Repair (BEAR)<br>The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into. | Device: BEAR Scaffold<br>* A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.<br>|
| Active Comparator: Tendon Graft<br>ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL. | Procedure: Tendon Graft<br>* A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Score | This is a survey taken by patients to report how their knee is working for them. | 2 years after surgery | 
| Instrumented Anteroposterior (AP) laxity testing | This is a test of how stable the knee is. | 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamstring and Quadriceps Strength | Measured by a hand-held dynamometer on both the involved and contralateral knees | 3 months to 2 years out from surgery | 
| Patient Reported Outcomes Score | This is a survey taken by patients to report how their knee is working for them | Baseline, 6 months, 1 year and 6 and 10 years after surgery. | 
| X-ray Imaging | A semiflexed weight bearing MTP view, as well as a lateral projection | Baseline and 2, 6 and 10 years after surgery. | 
| MR imaging | MR imaging with the CISS sequence will be used to measure the volume and orientation of both the repaired knee and the contralateral knee | Baseline and 2, 6 and 10 years after surgery. |