NCT02664545

Bridge-Enhanced ACL Repair vs ACL Reconstruction

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)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Miach Orthopaedics · Industry
• Sex: All
• Age: 14 Years – 35 Years
• Healthy volunteers: Accepted

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.

Detailed description

Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).

Conditions

• Anterior Cruciate Ligament Tear

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-06-19
• Completion: 2028-05-31
• First posted: 2016-01-27
• Last updated: 2025-12-30
• Results posted: 2024-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study