Summary
The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.
Conditions
Anterior Cruciate Ligament Tear
Recruitment Status
Active, not recruiting
Detailed Description
Enrolled patients will be randomized to either the Bridge-Enhanced ACL Repair (BEAR) technique (new treatment) or an ACL reconstruction (current gold standard of treatment).
Eligibility Criteria
Inclusion Criteria:
Age: 14 to 35 years of age.
Sex: Both male and female
ACL: Complete tear
Time from injury to surgery: ≤45 days
MRI: ACL tissue present on pre-operative MRI - at least 50% of the ACL length must still be attached to the tibial plateau
Exclusion Criteria:
Prior surgery on affected knee
Prior joint infection on affected knee
Regular use of tobacco or nicotine
Use of corticosteroid within last 3 months
History of chemotherapy treatment
History of sickle cell disease
History of anaphylaxis
Any condition that could affect healing or infection risk (Diabetes, inflammatory arthritis, etc)
Operative posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
Grade III medial collateral ligament injury
Complete patellar dislocation
Known allergy to bovine, beef or cow products
Intervention
Intervention Type
Intervention Name
Device
BEAR Scaffold
Procedure
Tendon Graft
Phase
Not Applicable
Gender
All
Min Age
14 Years
Max Age
35 Years
Download Date
January 10, 2024
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: