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

Conditions: Anterior Cruciate Ligament Injuries

Sex: All

Ages: 14 Years – N/A

Healthy volunteers: No

Enrollment: 300

Sponsor: Miach Orthopaedics

Location: Stanford Redwood City California

Summary

The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.

Eligibility Criteria

Inclusion Criteria for Prospective Cohort: 1. Scheduled to undergo ACL surgery with the BEAR Implant 2. Willing and able to provide informed consent 3. 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: 1. 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 2. Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05398341). StuddyBuddy aggregates publicly available trial information.