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A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
Sponsor: Miach Orthopaedics
Summary
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2023-02-28
Completion Date
2027-01-30
Last Updated
2025-08-03
Healthy Volunteers
No
Conditions
Interventions
The BEAR® Implant
The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy \[BSE\] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.
Locations (9)
Stanford
Redwood City, California, United States
Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, United States
Advent Health
Orlando, Florida, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Virtua Health
Marlton, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
Victory Sports Medicine
Skaneateles, New York, United States
Duke University
Durham, North Carolina, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States