Status:
ACTIVE_NOT_RECRUITING
A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
Lead Sponsor:
Miach Orthopaedics
Conditions:
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
14+ years
Brief Summary
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
Detailed Description
This is an observational study, where the BEAR Implant will be evaluated in a real-world setting. The registry seeks to enroll consecutive uses of the BEAR Implant at participating sites. There will b...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Prospective Cohort:
- Scheduled to undergo ACL surgery with the BEAR Implant
- Willing and able to provide informed consent
- Willing and able to complete required follow-up visits and assessments
- Inclusion Criteria for Retrospective Cohort:
- 1\. Underwent ACL surgery with the BEAR Implant
- Exclusion Criteria:
- The subject is participating in another ACL trial or any other clinical trial where the study procedure or treatment might confound the study end point
- Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
Exclusion
Key Trial Info
Start Date :
February 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05398341
Start Date
February 28 2023
End Date
January 30 2027
Last Update
August 3 2025
Active Locations (9)
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1
Stanford
Redwood City, California, United States, 94063
2
Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, United States, 80487
3
Advent Health
Orlando, Florida, United States, 32804
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02453