Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts |
More Miach Orthopaedics trials in the USA
Other trials for the same condition
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