NCT02292004

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

Bridge-Enhanced ACL Repair-Safety Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Miach Orthopaedics · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.)

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 observational study of 20 patients: 10 experimental and 10 control.

Conditions

• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Tear

Interventions

Type	Name	Description
DEVICE	ACL Repair with MIACH Scaffold	Surgical insertion of the MIACH scaffold to promote ACL healing/repair
PROCEDURE	Standard ACL Reconstruction	Standard surgical reconstruction of the ACL with autograft hamstring tendon

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-03-19
• Completion: 2026-12-31
• First posted: 2014-11-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study