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ACTIVE NOT RECRUITING
NCT02292004
NA

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

Sponsor: Miach Orthopaedics

View on ClinicalTrials.gov

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.)

Official title: Bridge-Enhanced ACL Repair-Safety Study

Key Details

Gender

All

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2015-01

Completion Date

2026-12-31

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

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

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States