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

Launched by MIACH ORTHOPAEDICS · May 26, 2022

Keywords

ClinConnect Summary

The Bridge Registry is a clinical trial aimed at studying the effectiveness of a special device called the BEAR Implant, which is used in surgery for knee injuries, specifically for repairing the anterior cruciate ligament (ACL). This trial is looking to see how well the BEAR Implant works in real-life situations after it has been approved for use by the FDA. They are currently recruiting participants of all genders, aged 13 and older, who are planning to have ACL surgery using the BEAR Implant and are able to attend follow-up appointments.

To participate, individuals must be scheduled for surgery with the BEAR Implant and agree to take part in follow-up evaluations. However, people who are involved in other clinical trials or have known allergies to certain animal products that the BEAR Implant contains cannot participate. Those who join the study can expect to undergo their normal surgery and then provide information on their recovery and outcomes over time. This helps researchers understand how well the BEAR Implant works outside of the controlled clinical trial environment.

Gender

ALL

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