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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Intrinsic Therapeutics
Sponsor:
Information provided by (Responsible Party):
Intrinsic Therapeutics
ClinicalTrials.gov Identifier:
NCT01283438
First received: January 6, 2011
Last updated: May 29, 2014
Last verified: May 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: 500
Study Start Date: December 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (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

Contacts
Contact: Ivan Grzan 781-932-0222 ext 171

Locations
Austria
LKH Graz Recruiting
Graz, Austria
Contact: Karin Pistracher, MD    +4331638582044      
Principal Investigator: Sandro Eustacchio, MD         
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria
Contact: Claudius Thomé, Prof. Dr.    +496213832360      
Principal Investigator: Claudius Thomé, Prof. Dr.         
Belgium
OLV Aalst Active, not recruiting
Aalst, Belgium
ZNA Middleheim Recruiting
Antwerp, Belgium
Contact: Robert Hes, MD    +32 03 280 31 11      
Principal Investigator: Robert Hes, MD         
AZ Nikolaas Recruiting
Sint Niklaas, Belgium
Contact: Erik Van de Kelft    +3237602172      
Sub-Investigator: David Van der Planken, MD         
Germany
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock Recruiting
Rostock, Mecklenburg-Vorpommern, Germany, D-18055
Contact: Susanne Fröhlich, MD    +493814949317      
Principal Investigator: Susanne Fröhlich, MD         
Sub-Investigator: Dorit Panser-Schulz, MD         
Neurochirurgische Universitätsklinik Knappschafts-Krankenhaus Bochum-Langendreer Recruiting
Bochum, North Rhine-Westphalia, Germany, 44892
Contact: Martin B. Barth, MD    +4923429980268      
Principal Investigator: Martin B. Barth, MD         
Sub-Investigator: Christopher Brenke, MD         
Klinikum Augsburg Recruiting
Augsburg, Germany
Contact: Claudia Fischer    +498214002251      
Principal Investigator: Volkmar Heidecke, MD         
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Heike Schneider    +4930450660349      
Principal Investigator: Peter Vajkoczy, Prof. Dr.         
UKB Berlin Withdrawn
Berlin, Germany
Klinikum Deggendorf Active, not recruiting
Deggendorf, Germany
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Richard Bostelmann, MD    +492118118391      
Principal Investigator: Richard Bostelmann, MD         
Asklepios Westklinikum Hamburg Recruiting
Hamburg, Germany
Contact: Hans-Peter Köhler, MD    +494081912645      
Sub-Investigator: Ekkehard von Saldern, MD         
UNI Kiel Recruiting
Kiel, Germany
Contact: Hubertus M. Medhorn, Prof. Dr.    +49431 597 4800      
Principal Investigator: Hubertus M. Medhorn, Prof. Dr.         
St. Bonifatius Hospital GmbH Active, not recruiting
Lingen, Germany
UMM Mannheim Active, not recruiting
Mannheim, Germany
Netherlands
SLAZ Amsterdam Recruiting
Amsterdam, Netherlands
Contact: Gert J. Bouma, MD    +31 20 510 8740      
Principal Investigator: Gert J. Bouma, MD         
MCH Westeinde Recruiting
Den Haag, Netherlands
Contact: Jasper Wolfs, MD    +31703302000      
Principal Investigator: Jasper Wolfs, MD         
MCH Antoniushove Recruiting
Leidschendam, Netherlands
Contact: Mark Arts, MD    +31 70 3574444      
Principal Investigator: Mark Arts, MD         
Isala Klinieken Recruiting
Zwolle, Netherlands, 8025AB
Contact: Mirjam de Wit    +31384245000      
Principal Investigator: Wimar A van den Brink, MD         
Sub-Investigator: Dharmin Nanda, MD         
Switzerland
KSA Aarau Active, not recruiting
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: May 29, 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
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014