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ACTIVE NOT RECRUITING
NCT02664545
NA

Bridge-Enhanced ACL Repair vs ACL Reconstruction

Sponsor: Miach Orthopaedics

View on ClinicalTrials.gov

Summary

The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.

Official title: A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)

Key Details

Gender

All

Age Range

14 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2016-04

Completion Date

2028-05-31

Last Updated

2025-12-30

Healthy Volunteers

Yes

Interventions

DEVICE

BEAR Scaffold

A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.

PROCEDURE

Tendon Graft

A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States