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

Miach Orthopaedics

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Tear

Treatments: Procedure: Standard ACL Reconstruction; Device: ACL Repair with MIACH Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT02292004

IRB-P00012985

Details and patient eligibility

About

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.)

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

ACL repair with MIACH scaffold

Experimental group

Description:

Patients will undergo ACL repair surgery using the newly developed MIACH scaffold

Treatment:

Device: ACL Repair with MIACH Scaffold

Standard ACL reconstruction

Active Comparator group

Description:

Patients will undergo a standard ACL reconstruction surgery

Treatment:

Procedure: Standard ACL Reconstruction