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Bridge-Enhanced ACL Repair vs ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT02664545
Recruitment Status : Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Miach Orthopaedics

Brief 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Device: BEAR Scaffold Procedure: Tendon Graft Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bridge-Enhanced ACL Repair (BEAR)
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.
Device: BEAR Scaffold
A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.

Active Comparator: Tendon Graft
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.
Procedure: Tendon Graft
A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)




Primary Outcome Measures :
  1. Patient Reported Outcomes Score [ Time Frame: 2 years after surgery ]
    This is a survey taken by patients to report how their knee is working for them.

  2. Instrumented Anteroposterior (AP) laxity testing [ Time Frame: 2 years after surgery ]
    This is a test of how stable the knee is.


Secondary Outcome Measures :
  1. Hamstring and Quadriceps Strength [ Time Frame: 3 months to 2 years out from surgery ]
    Measured by a hand-held dynamometer on both the involved and contralateral knees

  2. Patient Reported Outcomes Score [ Time Frame: Baseline, 6 months, 1 year and 6 and 10 years after surgery. ]
    This is a survey taken by patients to report how their knee is working for them

  3. X-ray Imaging [ Time Frame: Baseline and 2, 6 and 10 years after surgery. ]
    A semiflexed weight bearing MTP view, as well as a lateral projection

  4. MR imaging [ Time Frame: Baseline and 2, 6 and 10 years after surgery. ]
    MR imaging with the CISS sequence will be used to measure the volume and orientation of both the repaired knee and the contralateral knee



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Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664545


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Miach Orthopaedics
Investigators
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Principal Investigator: Dennis Krammer, MD Boston Children's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Miach Orthopaedics
ClinicalTrials.gov Identifier: NCT02664545    
Other Study ID Numbers: BEAR II TRIAL
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries