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Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

Bridge-Enhanced ACL Repair-Safety Study

NCT02292004•Miach Orthopaedics

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.

Eligibility

Age

18 - 35 years

Sex

ALL

Healthy Volunteers

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

•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
+7 more criteria

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Key Dates

Start Date

January 1, 2015

Primary Completion Date

March 19, 2018

Completion Date

December 31, 2026

Last Updated

December 17, 2025

Enrollment

ACTUAL participants

Conditions

Anterior Cruciate Ligament InjuryAnterior Cruciate Ligament Tear

Interventions

ACL Repair with MIACH Scaffold

DEVICE

Standard ACL Reconstruction

PROCEDURE

Vitamin D to Improve Quadricep Muscle Strength

NCT05174611

Anterior Cruciate Ligament InjuriesQuadriceps Muscle Atrophy+2 more

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ACTIVE_NOT_RECRUITINGNA

Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction

NCT07475351

Anterior Cruciate Ligament (ACL) ReconstructionAnterior Cruciate Ligament Injury

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Vitamin D to Improve Quadricep Muscle Strength

Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction

Relationship Between Muscle Strength and Balance

Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength

Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

Werewolf Flow 50 During ACL Reconstruction