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

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).