MIACH Scaffold for ACL Tear
(BEAR Trial)
Trial Summary
What is the purpose of this trial?
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.)
Research Team
Lyle Micheli, MD
Principal Investigator
Boston Children's Hospital
Eligibility Criteria
This trial is for individuals with a complete ACL tear confirmed by MRI, and the injury must have occurred within the last 90 days. Participants should still have some ACL tissue visible on pre-operative MRI.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo ACL repair surgery using the MIACH scaffold or standard ACL reconstruction
Post-operative Monitoring
Participants are monitored for safety and early efficacy, including inflammatory reactions, muscle atrophy, and excessive pain
Follow-up
Participants are monitored for long-term outcomes such as AP knee laxity
Treatment Details
Interventions
- MIACH Scaffold
Find a Clinic Near You
Who Is Running the Clinical Trial?
Miach Orthopaedics
Lead Sponsor