This trial is active, not recruiting.

Condition lumbar disc herniation
Treatments barricaid, standard of care
Phase phase 4
Sponsor Intrinsic Therapeutics
Start date December 2010
End date October 2016
Trial size 550 participants
Trial identifier NCT01283438, EUBARD-CP-001


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Intervention: Barricaid Device
CE Marked Device
(Active Comparator)
Standard (Limited) Discectomy Only
standard of care
Standard Limited discectomy

Primary Outcomes

Composite of pain, function and safety
time frame: 24 months
No evidence of recurrent herniation.
time frame: 24 months

Secondary Outcomes

Visual Analog Scale (VAS) Back Pain Improvement
time frame: 24 months
Disc Height Maintenance
time frame: 24 months
Oswestry Disability Index (ODI) Improvement
time frame: 24 months

Eligibility Criteria

All participants from 21 years up to 75 years old.

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).

Additional Information

Official title A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Intrinsic Therapeutics.