MIACH Scaffold for ACL Tear
(BEAR Trial)
What You Need to Know Before You Apply
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.)
Who Is on the Research Team?
Lyle Micheli, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- MIACH Scaffold
Find a Clinic Near You
Who Is Running the Clinical Trial?
Miach Orthopaedics
Lead Sponsor