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

Anterior Cruciate Ligament Injury Clinical Trial

Official title:
Bridge-Enhanced ACL Repair-Safety Study

Clinical Trial 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.)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02292004
Study type Interventional
Source Miach Orthopaedics
Contact
Status Active, not recruiting
Phase N/A
Start date January 2015
Completion date February 2025
View Details
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