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The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
Sponsor: Miach Orthopaedics
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
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