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

Miach Orthopaedics

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Device: The BEAR® Implant

Study type: Observational

Funder types: Industry

Identifiers

NCT05398341

Bridge Registry

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 2 patient groups

Prospective Cohort

Description:

There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent.

Treatment:

Device: The BEAR® Implant

Retrospective Cohort

Description:

A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group.

Treatment:

Device: The BEAR® Implant