Bridge-Enhanced ACL Repair vs ACL Reconstruction

M

Miach Orthopaedics

Status

Active, not recruiting

Conditions

Anterior Cruciate Ligament Tear

Treatments

Procedure: Tendon Graft
Device: BEAR Scaffold

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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