Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

Study Overview
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Brief Summary
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This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)

Detailed Description
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This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.

Official Title
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Bridge-Enhanced ACL Repair-Safety Study

Conditions
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Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Device: ACL Repair with MIACH Scaffold
* Procedure: Standard ACL Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete ACL tear, confirmed by MRI Time from injury to screening must be less than or equal to 90 days ACL tissue present on pre-operative MRI Exclusion Criteria (before surgery): Prior surgery on affected knee History of prior infection in affected knee Regular use of tobacco or nicotine in any form Use of corticosteroid within last 6 months Ever underwent chemotherapy treatment History of sickle cell disease History of anaphylaxis Any condition that could affect healing (Diabetes, inflammatory arthritis, etc) Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament) Diagnosis of Grade III medial collateral ligament injury Diagnosis of complete patellar dislocation Exclusion Criteria (during surgery): ACL deemed normal on arthroscopic inspection Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group) Experimental Group: Less than 50 percent of ACL remaining Displaced bucket handle meniscal injury requiring repair Diagnosis of full-thickness chondral injury on either condyle Grade III medial collateral ligament injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACL repair with MIACH scaffold<br>Patients will undergo ACL repair surgery using the newly developed MIACH scaffold | Device: ACL Repair with MIACH Scaffold<br>* Surgical insertion of the MIACH scaffold to promote ACL healing/repair<br>|
| Active Comparator: Standard ACL reconstruction<br>Patients will undergo a standard ACL reconstruction surgery | Procedure: Standard ACL Reconstruction<br>* Standard surgical reconstruction of the ACL with autograft hamstring tendon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the BEAR® Implant | To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant | Surgery to 3-months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory reaction | Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms. | Surgery to 3-months post-op | 
| Muscle Atrophy | Patient cannot ambulate independently and continues to require crutches for ambulation for more than six weeks after surgery as a result of the muscle weakness. Patient report leg feels unstable ambulating without crutches at six weeks after surgery. | At 6-weeks post-op | 
| Excessive Pain | Patient needs to be readmitted to the hospital for parenteral (IV or IM) pain medications but no other adverse event (e.g. infection or inflammation) is found. | Surgery to 3-months post-op | 
| Implant failure | Lachman exam demonstrates 6mm or greater AP knee laxity when the knee is in 25 degrees of flexion in the operated knee than the unoperated knee on examination by the physician in the office. Both knees will be covered and the examining physician blinded to which knee was the surgical knee prior to the testing. | At 3-months post-op | 
| Anteroposterior (AP) knee laxity | KT-1000 testing of AP laxity in both knees reveals a side-to-side difference of >=6mm when performed by the clinician. The knees will be covered and the examiner blinded as to which is the operated knee. | At 6- and 12-months post-op |