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

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:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Intrinsic Therapeutics:

Primary Outcome Measures:

Improvement of primary pain score outcomes [ 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 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

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

Contacts

Contact: Keisha K. Smith	781-932-0222 ext 135
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	Recruiting
Aalst, Belgium
Contact: Hilde Keymeulen +3253724160
Principal Investigator: Frederic Martens, MD
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
Klinikum Augsburg	Recruiting
Augsburg, Germany
Contact: Claudia Fischer +498214002251
Principal Investigator: Volkmar Heidecke, MD
UKB Berlin	Not yet recruiting
Berlin, Germany
Contact: Marco Danne, MD +493056813721
Sub-Investigator: Marco Danne, MD
Charité - Universitätsmedizin Berlin	Recruiting
Berlin, Germany
Contact: Anett Übelacker +4930450660349
Principal Investigator: Peter Vajkoczy, Prof. Dr.
Klinikum Deggendorf	Recruiting
Deggendorf, Germany
Contact: Adisa Kursumovic, MD +4999113803601
Principal Investigator: Stefan Rath, Prof. Dr.
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	Active, not recruiting
Kiel, Germany
St. Bonifatius Hospital GmbH	Recruiting
Lingen, Germany
Contact: Peter D. Klassen, MD +49 059 1 9100
Principal Investigator: Peter D. Klassen, MD
UMM Mannheim	Recruiting
Mannheim, Germany
Contact: Martin B. Barth, MD +4917664617548
Principal Investigator: Martin B. Barth, MD
Netherlands
SLAZ Amsterdam	Recruiting
Amsterdam, Netherlands
Contact: Gert J. Bouma, MD +31 20 510 8740
Principal Investigator: Gert J. Bouma, MD
MCH Westeinde	Not yet recruiting
Den Haag, Netherlands
Contact: Jasper Wolfs, MD +31703302000
Principal Investigator: Jasper Wolfs, MD
MCH Antoniushove	Not yet recruiting
Leidschendam, Netherlands
Contact: Mark Arts, MD +31 70 3574444
Principal Investigator: Mark Arts, MD
Switzerland
KSA Aarau	Recruiting
Aarau, Switzerland
Contact: Javier Fandino, Prof. Dr. +4162 838 66 93
Principal Investigator: Javier Fandino, Prof. Dr.

Sponsors and Collaborators

Intrinsic Therapeutics

More Information

Additional Information:

Patient information This link exits the ClinicalTrials.gov site

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 27, 2012
Health Authority:	Germany: Ethics Commission Austria: Ethikkommission Belgium: Ethics Committee Netherlands: Medical Ethics Review Committee (METC) Switzerland: Ethikkommission

Additional relevant MeSH terms:

Hernia
Intervertebral Disk Displacement
Pathological Conditions, Anatomical

Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013