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

Not Applicable

Active, not recruiting

• Conditions: Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injury
• Interventions: Procedure: Standard ACL Reconstruction; Device: ACL Repair with MIACH Scaffold

• Registration Number: NCT02292004
• Lead Sponsor: Miach Orthopaedics

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-17
• Study Start: 2015-01
• Primary Completion: 2018-03-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard ACL reconstruction	Standard ACL Reconstruction	Patients will undergo a standard ACL reconstruction surgery
ACL repair with MIACH scaffold	ACL Repair with MIACH Scaffold	Patients will undergo ACL repair surgery using the newly developed MIACH scaffold

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Muscle Atrophy	At 6-weeks post-op	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.
Implant failure	At 3-months post-op	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.
Inflammatory reaction	Surgery to 3-months post-op	Tense effusion limiting motion, fever or increased knee pain for more than three weeks after surgery and synovial fluid culture is negative for organisms.
Excessive Pain	Surgery to 3-months post-op	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.
Anteroposterior (AP) knee laxity	At 6- and 12-months post-op	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States