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

NCT05398341 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-08-03

No results posted yet for this study

Summary

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

Conditions

  • Anterior Cruciate Ligament Injuries

Interventions

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.

Sponsors & Collaborators

  • Miach Orthopaedics

    lead INDUSTRY

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2026-10-30
Completion
2027-01-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05398341 on ClinicalTrials.gov