Current Environment:

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

Minimum Age

14 Years

Maximum Age

35 Years

Download Date

September 14, 2021

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: