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Active, not recruiting Not applicable

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

NCT02292004 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2015-01
Last updated
2026-06-09

Condition(s) studied

Anterior Cruciate Ligament InjuryAnterior Cruciate Ligament Tear

Investigational drug(s) / intervention(s)

ACL Repair with MIACH ScaffoldStandard ACL Reconstruction

ACL Repair with MIACH Scaffold: Surgical insertion of the MIACH scaffold to promote ACL healing/repair

Standard ACL Reconstruction: Standard surgical reconstruction of the ACL with autograft hamstring tendon

Study 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.)

Eligibility

Sex
ALL
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Boston Children's Hospital Boston Massachusetts
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02292004 on ClinicalTrials.gov ↗ ← All trials in the USA