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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 including a post-approval amendment with follow-up visits at 7 & 10 years for eligible subjects.

Official Title
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A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid® to Discectomy for Primary Lumbar Disc Herniation: Extended Follow-Up of the Barricaid® Annular Closure Device (ACD) Randomized Control Trial (RCT) Postmarket Cohort for Lumbar Disc Herniation and Interaction With Other Risk Factors

Conditions
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Lumbar Disc Herniation

Intervention / Treatment
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* Device: Barricaid
* Device: Standard of Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barricaid Device<br>Intervention: Barricaid Device | Device: Barricaid<br>* Annular closure device<br>|
| Active Comparator: Standard of Care<br>Standard (Limited) Discectomy Only | Device: Standard of Care<br>* Standard Limited discectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined success of multiple clinical outcomes, including Oswestry disability index, Visual Analog Scale (VAS), and multiple radiographically confirmed measures | 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 | 24 months | 
| No radiographic evidence of recurrent disc herniation | 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). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Back Pain Improvement | 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. | 24 months | 
| Oswestry Disability Index (ODI) Improvement | 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. | 24 months | 
| Reoperation | 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. | 24 months | 
| Visual Analog Scale (VAS) LEG Pain Improvement | 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. | 24 months | 
| Disc Height Maintenance | 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. | 24 months |