NCT05398341

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Miach Orthopaedics · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Anterior Cruciate Ligament Injuries

Interventions

Type	Name	Description
DEVICE	The BEAR® Implant	The BEAR Implant is a bovine collagen-based implant. The bovine tissue is sourced from countries that are free of bovine spongiform encephalopathy \[BSE\] and is further treated to remove bovine cell fragments and DNA. The BEAR® (Bridge Enhanced ACL Restoration) Implant is a bovine extracellular matrix collagen-based implant for treatment of anterior cruciate ligament (ACL) injuries. The BEAR® Implant is indicated for skeletally mature subjects at least 14 years of age with a complete rupture of the ACL. Subjects must have an ACL stump attached to the tibia to construct the repair.

Timeline

• Start date: 2023-02-28
• Primary completion: 2026-10-30
• Completion: 2027-01-30
• First posted: 2022-05-31
• Last updated: 2025-08-03

Locations

9 sites across 1 country: United States