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

Intrinsic Therapeutics554 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

554

Conditions

Lumbar Disc Herniation

Interventions

BarricaidDEVICE

Annular closure device

Standard of CareDEVICE

Standard Limited discectomy

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (21)

LKH Graz

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Outcomes

Primary Outcomes

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

Time frame: 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).

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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