Status:
ACTIVE_NOT_RECRUITING
Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
Lead Sponsor:
Miach Orthopaedics
Conditions:
Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Tear
Eligibility:
All Genders
18-35 years
Phase:
NA
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 under...
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 observati...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02292004
Start Date
January 1 2015
End Date
December 31 2026
Last Update
December 17 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115