ACTIVE_NOT_RECRUITING

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

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Conditions

Anterior Cruciate Ligament InjuriesACLACL surgeryACL tearTorn ACLBEAR ImplantBEAR ACLBEAR restorationBridge-enhanced ACL restorationACL restorationACL implant bridge

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-02-28
Study Completion:2027-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05398341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 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. 2. Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling

Contacts and Locations

Study Locations (Sites)

Stanford
Redwood City, California, 94063
United States
Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, 80487
United States
Advent Health
Orlando, Florida, 32804
United States
Boston Children's Hospital
Boston, Massachusetts, 02453
United States
Virtua Health
Marlton, New Jersey, 08053
United States
Hospital for Special Surgery
New York, New York, 10021
United States
Victory Sports Medicine
Skaneateles, New York, 13152
United States
Duke University
Durham, North Carolina, 27705
United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Miach Orthopaedics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28
Study Completion Date2027-01-30

Study Record Updates

Study Start Date2023-02-28
Study Completion Date2027-01-30

Terms related to this study

Keywords Provided by Researchers

  • ACL
  • ACL surgery
  • ACL tear
  • Torn ACL
  • BEAR Implant
  • BEAR ACL
  • BEAR restoration
  • Bridge-enhanced ACL restoration
  • ACL restoration
  • ACL implant bridge

Additional Relevant MeSH Terms

  • Anterior Cruciate Ligament Injuries