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ACTIVE NOT RECRUITING
NCT03348995
NA

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

Sponsor: Miach Orthopaedics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2018-04-17

Completion Date

2034-04-17

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

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.

Locations (11)

Scripps Health

San Diego, California, United States

Florida Orthopedic Institute

Tampa, Florida, United States

Emory University School Of Medicine

Atlanta, Georgia, United States

Ochsner Sports Medicine Institute

New Orleans, Louisiana, United States

MedStar Health Surgery Center of Timonium

Lutherville, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Virtua Health

Marlton, New Jersey, United States

Cynthia Chrostek

Providence, Rhode Island, United States

Orthopedic Institute of Sioux Falls

Sioux Falls, South Dakota, United States

UT Southwestern

Dallas, Texas, United States

Inova Sports Medicine

Fairfax, Virginia, United States