Bridge-Enhanced ACL Repair vs ACL Reconstruction

A Prospective, Randomized, Controlled, Clinical Trial Evaluating the Non-Inferiority of Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) to Anterior Cruciate Ligament Reconstruction With an Autologous Tendon Graft (ACLR)

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.

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).

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