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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intrinsic Therapeutics
ClinicalTrials.gov Identifier:
NCT01283438
First received: January 6, 2011
Last updated: November 26, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Lumbar Disc Herniation
Device: Barricaid
Device: Standard of Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

Resource links provided by NLM:


Further study details as provided by Intrinsic Therapeutics:

Primary Outcome Measures:
  • Composite of pain, function and safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • No evidence of recurrent herniation. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual Analog Scale (VAS) Back Pain Improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Disc Height Maintenance [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Oswestry Disability Index (ODI) Improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Barricaid Device
Intervention: Barricaid Device
Device: Barricaid
CE Marked Device
Active Comparator: Standard of Care
Standard (Limited) Discectomy Only
Device: Standard of Care
Standard Limited discectomy

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283438

Locations
Austria
LKH Graz
Graz, Austria
Medizinische Universität Innsbruck
Innsbruck, Austria
Belgium
OLV Aalst
Aalst, Belgium
ZNA Middleheim / AZ Klina
Antwerp, Belgium
AZ Nikolaas
Sint Niklaas, Belgium
France
CHRU Lille, Hôpital Roger Salengro
Lille, France, 59037
Germany
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
Rostock, Mecklenburg-Vorpommern, Germany, D-18055
Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer
Bochum, North Rhine-Westphalia, Germany, 44892
Klinikum Augsburg
Augsburg, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Klinikum Deggendorf
Deggendorf, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Asklepios Westklinikum Hamburg
Hamburg, Germany
UNI Kiel
Kiel, Germany
St. Bonifatius Hospital GmbH
Lingen, Germany
UMM Mannheim
Mannheim, Germany
Netherlands
SLAZ Amsterdam
Amsterdam, Netherlands
MCH Westeinde
Den Haag, Netherlands
MCH Antoniushove
Leidschendam, Netherlands
Isala Klinieken
Zwolle, Netherlands, 8025AB
Switzerland
KSA Aarau
Aarau, Switzerland
Sponsors and Collaborators
Intrinsic Therapeutics
  More Information

Additional Information:
No publications provided

Responsible Party: Intrinsic Therapeutics
ClinicalTrials.gov Identifier: NCT01283438     History of Changes
Other Study ID Numbers: EUBARD-CP-001
Study First Received: January 6, 2011
Last Updated: November 26, 2014
Health Authority: Germany: Ethics Commission
Austria: Ethikkommission
Belgium: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Switzerland: Ethikkommission

Additional relevant MeSH terms:
Hernia
Intervertebral Disc Displacement
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015