The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)
1 other identifier
interventional
250
1 country
11
Brief Summary
Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
11 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
November 17, 2017
CompletedFirst Posted
Study publicly available on registry
November 21, 2017
CompletedStudy Start
First participant enrolled
April 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2034
ExpectedDecember 15, 2025
December 1, 2025
7.8 years
November 17, 2017
December 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
International Knee Documentation Committee Subjective Score (IKDC) (Survey)
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.
Time points up to two years
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)
This is an examination performed of the knee. Scores are one of four measures: A (Normal), B (Nearly Normal), C (Abnormal) and D (Severely Abnormal). A is the best outcome and D is the worst.
Time points up to two years.
Secondary Outcomes (2)
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Time points up to two years
Repair Failure
Two years
Study Arms (1)
Bridge-Enhanced ACL Restoration (BEAR)
EXPERIMENTALThe BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into
Interventions
In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (11)
Scripps Health
San Diego, California, 92121, United States
Florida Orthopedic Institute
Tampa, Florida, 33637, United States
Emory University School Of Medicine
Atlanta, Georgia, 30329, United States
Ochsner Sports Medicine Institute
New Orleans, Louisiana, 70121, United States
MedStar Health Surgery Center of Timonium
Lutherville, Maryland, 21093, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Virtua Health
Marlton, New Jersey, 08053, United States
Cynthia Chrostek
Providence, Rhode Island, 02903, United States
Orthopedic Institute of Sioux Falls
Sioux Falls, South Dakota, 57105, United States
UT Southwestern
Dallas, Texas, 75390, United States
Inova Sports Medicine
Fairfax, Virginia, 22031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2017
First Posted
November 21, 2017
Study Start
April 17, 2018
Primary Completion
January 31, 2026
Study Completion (Estimated)
April 17, 2034
Last Updated
December 15, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share