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

Phase

NA

Gender

ALL

Min Age

14 Years

Max Age

35 Years

Download Date

2025-05-25

Principal Investigator

N/A

Intervention

Intervention Type

DEVICE

PROCEDURE

Intervention Name

BEAR Scaffold

Tendon Graft

Contact

For more information and to contact the study team:

Bridge-Enhanced ACL Repair vs ACL Reconstruction NCT02664545