A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
NCT ID: NCT05398341
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2023-02-28
2027-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
NCT03348995
Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
NCT06041763
Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
NCT02292004
Bridge-Enhanced ACL Repair vs ACL Reconstruction
NCT02664545
A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction
NCT03776162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective Cohort
There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent.
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.
Retrospective Cohort
A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Willing and able to provide informed consent
3. Willing and able to complete required follow-up visits and assessments
1\. Underwent ACL surgery with the BEAR Implant
Exclusion Criteria
2. Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
14 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Miach Orthopaedics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Bridge Registry
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.