Status:
ACTIVE_NOT_RECRUITING
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
Lead Sponsor:
Miach Orthopaedics
Conditions:
Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
12-80 years
Phase:
NA
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 pati...
Detailed Description
The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (BEAR) as defined by an 11.5 point difference on the IKDC...
Eligibility Criteria
Inclusion
- ACL tear, within 50 days of injury, at least 5% of the ACL attached to the tibia.
- \-
Exclusion
- Prior surgery on the affected knee, history of knee infection, use of tobacco, use of corticosteroid, chemotherapy, allergy to bovine products or gelatin, history of anaphylaxis, BMI over 35, moderate osteoarthritis.
- \-
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 17 2034
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03348995
Start Date
April 17 2018
End Date
April 17 2034
Last Update
December 15 2025
Active Locations (11)
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1
Scripps Health
San Diego, California, United States, 92121
2
Florida Orthopedic Institute
Tampa, Florida, United States, 33637
3
Emory University School Of Medicine
Atlanta, Georgia, United States, 30329
4
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121