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

Intrinsic Therapeutics

Status and phase

Active, not recruiting

Phase 4

Conditions

Lumbar Disc Herniation

Treatments

Device: Standard of Care

Device: Barricaid

Study type

Interventional

Funder types

Industry

Identifiers

NCT01283438

EUBARD-CP-011

Details and patient eligibility

About

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.

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

Enrollment

554 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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).