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Clinical Trials in the USA / NCT05398341
Active, not recruiting Observational

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

NCT05398341 · tracked via the Priya Life Science USA tracker
Sponsor
Miach Orthopaedics
Phase
Observational
Started
2023-02-28
Last updated
2026-06-09

Condition(s) studied

Anterior Cruciate Ligament Injuries

Investigational drug(s) / intervention(s)

The BEAR® Implant

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.

Study summary

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

Eligibility

Sex
ALL
Min age
14 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2 — 2 Years
    This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.
  • Knee laxity based on the Lachman test at 1 year — 1 year
    The Lachman will be performed during physical exam.

Trial sites (8)

FacilityCityRegionStatus
Stanford Redwood City California
Steamboat Orthopaedic and Spine Institute Steamboat Springs Colorado
Advent Health Orlando Florida
Virtua Health Marlton New Jersey
Hospital for Special Surgery New York New York
Victory Sports Medicine Skaneateles New York
Duke University Durham North Carolina
Oregon Health & Science University (OHSU) Portland Oregon

More Miach Orthopaedics trials in the USA

Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial) Active, not recruiting
Bridge-Enhanced ACL Repair vs ACL Reconstruction Active, not recruiting
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05398341 on ClinicalTrials.gov ↗ ← All trials in the USA