NCT03348995

The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Miach Orthopaedics · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Detailed description

The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Conditions

• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DEVICE	Bridge-Enhanced ACL Restoration (BEAR)	In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.

Timeline

• Start date: 2018-04-17
• Primary completion: 2026-01-31
• Completion: 2034-04-17
• First posted: 2017-11-21
• Last updated: 2025-12-15

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study