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A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

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ClinicalTrials.gov Identifier: NCT01283438
Recruitment Status : Active, not recruiting
First Posted : January 26, 2011
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Intrinsic Therapeutics

Brief Summary:
A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Device: Barricaid Device: Standard of Care Phase 4

Detailed Description:
The Barricaid is indicated for patients with radiculopathy (with or without back pain), a positive Straight Leg Raise (L45, L5S1) or femoral stretch test (L12, L23, L34), and a posterior or posterolateral herniation at one level between L1 and S1 with radiographic confirmation of neural compression using MRI who are found to have an annular defect (post discectomy) which measures between 4mm and 6mm tall and between 6mm and 10mm wide, have a minimum posterior disc height of 5mm, and have failed at least 6 weeks of conservative treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
Actual Study Start Date : December 17, 2010
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Barricaid Device
Intervention: Barricaid Device
Device: Barricaid
CE Marked Device

Active Comparator: Standard of Care
Standard (Limited) Discectomy Only
Device: Standard of Care
Standard Limited discectomy




Primary Outcome Measures :
  1. Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures [ Time Frame: 24 months ]

    To be considered a success, a patient will have achieved success in each of the following outcomes:

    • 15 point (out of 100 point scale) improvement in Oswestry compared to pre-op
    • 20 point (on a 100 point scale) improvement in VAS Leg (based on the primary leg complaint; if both legs have a minimum of 40/100 pre-operatively, the average leg score will be used)
    • Maintenance of average disc height (75% or greater of preoperative disc height) compared to pre-op
    • No deterioration of neurological status at the index level measured by motor function
    • Device integrity and lack of implant migration (radiographic, implanted patients only)
    • No radiographically confirmed spontaneous fusion
    • No radiographically or surgically confirmed reherniation at the index level (on either side)
    • No secondary surgical interventions at the index level

  2. No radiographic evidence of recurrent disc herniation [ Time Frame: 24 months ]
    To be considered a success, a patient will have no evidence of recurrent disc herniation at the index level at any time up to and including the 24-month follow-up. Recurrent herniation may be confirmed surgically, or radiographically as determined by an independent review (unless surgically confirmed that the suspected herniation is not a herniation, e.g. scar tissue or residual nucleus material).


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) Back Pain Improvement [ Time Frame: 24 months ]
    Change in back pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on the VAS back at 24 months, relative to baseline.

  2. Oswestry Disability Index (ODI) Improvement [ Time Frame: 24 months ]
    Change in function as measured using the Oswestry Disability Index (ODI). The ODI is scored on a scale from 0% to 100%, with higher scores indicating higher levels of disability. A subject is a success if there is at least a 15 point improvement (decrease) in the ODI at the 24 month visit relative to baseline.

  3. Reoperation [ Time Frame: 24 months ]
    A subject will be deemed a success if they have not had a second operation at the index level by the 24 month visit. Rates of subject success in treatment and control will be compared at 24 months. A subject is a success if there is at least 75% of the pre-op disc height preserved at the 24 month visit.

  4. Visual Analog Scale (VAS) LEG Pain Improvement [ Time Frame: 24 months ]
    Change in leg pain as measured using a Visual Analog Scale (VAS), on a scale of 0-100, with lower values representing better outcome. A subject is a success if there is at least a 20 point improvement on VAS leg pain in the ipsilateral leg at 24 months, relative to baseline.

  5. Disc Height Maintenance [ Time Frame: 24 months ]
    A subject is a success if there is at least 75% of the pre-op disc height preserved as measured on MRI, at the 24 month visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 to 75 years old and skeletally mature (male or female).
  • Patients with posterior or posterolateral disc herniations at one level between L1 and S1 with radiographic confirmation of neural compression using Magnetic Resonance Imaging (MRI).
  • At least six (6) weeks of failed, conservative treatment prior to surgery
  • Oswestry Disability Index (ODI) Questionnaire score of at least 40/100 at baseline.
  • Visual Analog Scale (VAS) leg pain (one or both legs) of at least 40/100 at baseline.
  • Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria:

  • Spondylolisthesis Grade II or higher (25% slip or greater).
  • Prior surgery at the index lumbar vertebral level.
  • Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).
  • Any metabolic bone disease.
  • Subject has insulin-dependent diabetes mellitus.
  • Subject has been diagnosed with active hepatitis, acquired immunodeficiency syndrome (AIDS), or Human immunodeficiency virus (HIV).
  • Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.
  • Subject has a known allergy to titanium, polyethylene or polyester materials.
  • Any subject that cannot have a baseline MRI taken.
  • Subject is pregnant or interested in becoming pregnant in the next three (3) years.
  • Subject has active tuberculosis or has had tuberculosis in the past three (3) years.
  • Subject is currently involved in another investigational study.
  • Any contraindication for MRI or Computed tomography CT scan (e.g. claustrophobia, contrast allergy).

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): NCT01283438


Locations
Show Show 21 study locations
Sponsors and Collaborators
Intrinsic Therapeutics
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Intrinsic Therapeutics
ClinicalTrials.gov Identifier: NCT01283438    
Other Study ID Numbers: EUBARD-CP-001
First Posted: January 26, 2011    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical