A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)
1 other identifier
observational
300
1 country
9
Brief Summary
The purpose of the Bridge Registry is to assess real-world performance of the FDA approved BEAR Implant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
February 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2027
August 3, 2025
May 1, 2025
3.7 years
May 26, 2022
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at year 2
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.
2 Years
Knee laxity based on the Lachman test at 1 year
The Lachman will be performed during physical exam.
1 year
Secondary Outcomes (7)
IKDC Subjective Knee Evaluation Score and Physical Exam at 6, 9 and 12 months post-surgery and according to standard of care
6-12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) domains: Symptoms/Stiffness, Pain, Knee Related Quality of Life, and Knee Related Sports/Recreational Activities starting at 6, 9, 12 months and at 2 years after surgery
6 months- 2 years post surgery
Marx Activity Score at 6, 9, 12 months and at 2 years after surgery
6 months thru 2 years
Return to Sports Index (RSI) at 6, 9, 12 months and at 2 years after surgery
6 months thru 2 years
VAS (Visual Analog Scale) Pain Score from post op through the first 12 months (approximately every 12 weeks) and at 2 years after surgery
1 year
- +2 more secondary outcomes
Study Arms (2)
Prospective Cohort
There will be a prospective cohort for all subjects scheduled to undergo ACL surgery with the BEAR Implant that are willing to provide consent.
Retrospective Cohort
A retrospective cohort will be available for all subjects treated with the BEAR Implant at each participating site. There is no control group.
Interventions
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.
Eligibility Criteria
The registry will enroll consecutive subjects who meet the inclusion criteria with an expected sample size of up to 750 subjects.
You may qualify if:
- Scheduled to undergo ACL surgery with the BEAR Implant
- Willing and able to provide informed consent
- Willing and able to complete required follow-up visits and assessments
- \. Underwent ACL surgery with the BEAR Implant
You may not qualify if:
- 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
- Known allergy to bovine collagen, bovine gelatin or other bovine-derived products as contraindicated in the BEAR Implant labeling
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2022
First Posted
May 31, 2022
Study Start
February 28, 2023
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
January 30, 2027
Last Updated
August 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share