A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)

Active, not recruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

February 28, 2023

Primary Completion Date

October 30, 2026

Study Completion Date

January 30, 2027

Conditions
Anterior Cruciate Ligament Injuries
Interventions
DEVICE

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."

Trial Locations (9)

10021

Hospital for Special Surgery, New York

13152

Victory Sports Medicine, Skaneateles

27705

Duke University, Durham

32804

Advent Health, Orlando

80487

Steamboat Orthopaedic and Spine Institute, Steamboat Springs

94063

Stanford, Redwood City

97239

Oregon Health & Science University (OHSU), Portland

02453

Boston Children's Hospital, Boston

08053

Virtua Health, Marlton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Miach Orthopaedics

INDUSTRY