Overview
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
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 be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent. A retrospective cohort will be available for all subjects treated with a BEAR Implant at each participating site. There is no control group.
Eligibility
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:
- 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