Bridge-Enhanced ACL Repair vs ACL Reconstruction

Miach Orthopaedics

Status: Active, not recruiting

Conditions: Anterior Cruciate Ligament Tear

Treatments: Device: BEAR Scaffold; Procedure: Tendon Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT02664545

BEAR II TRIAL

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 14 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Bridge-Enhanced ACL Repair (BEAR)

Experimental group

Description:

The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.

Treatment:

Device: BEAR Scaffold

Tendon Graft

Active Comparator group

Description:

ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.

Treatment:

Procedure: Tendon Graft