Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier:
NCT00749996
First received: September 9, 2008
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.


Condition Intervention Phase
Sciatica
Back Pain
Device: DIAM™ Spinal Stabilization System
Procedure: Herniectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Herniectomy vs. Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

Resource links provided by NLM:


Further study details as provided by Medtronic Spinal & Biologics ECA:

Primary Outcome Measures:
  • To demonstrate a statistically significant difference in the relief of back pain between both treatment groups. The endpoint will be the difference between baseline and 6-month of the patient's back-pain score on a Visual Analogue Scale (VAS). [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To demonstrate a statistically significant difference in the reduction of disability between both treatment groups. The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI). [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 165
Study Start Date: November 2006
Study Completion Date: June 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational group
Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
Device: DIAM™ Spinal Stabilization System
The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
Active Comparator: Control group
Single level herniectomy
Procedure: Herniectomy
Herniectomy is defined as the "removal of the extruded/protruded/sequestrated disc material". This is done by probing the annulus and disc space and removing all mobile disc fragments.

Detailed Description:

This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups:

Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a history of sciatica (radicular pain) for at least 6 weeks, but not more than 1 year secondary to one symptomatic lumbar disc herniation at the levels L2-L5 as confirmed by patient history and clinical evaluation, and without major neurological impairment (i.e. not less than M 3/5; Medical Research Council Classification);
  • Has a history of continuous low back pain for no more than 1 year secondary to lumbar degenerative disc disease (intermittent back pain may occur for more than a year);
  • Has pre-treatment back pain score greater than or equal to 3, concomitant with leg pain score greater than or equal to 6. Leg pain score must be greater than back pain score (pain intensity score measured on a 10 cm VAS scale);
  • Has one symptomatic disc herniation: protrusion, extrusion or sequestration (Milette & Fardon, 2001) as confirmed by MRI at the target level;
  • Evidence of disc degeneration ≤ Grade IV at the target and adjacent levels as confirmed by MRI (Pfirrmann, 2001);
  • Has an Oswestry Disability Index (ODI) score ≥ 34%;
  • Has been treated non-operatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, hydrotherapy, acupressure/acupuncture, massage, bracing and/or spinal injections) for at least 6 continuous weeks unless strong clinical grounds for expediting surgery;
  • Patient male or female, age 20-60 years inclusive and is skeletally mature;
  • Is willing and able to comply with the study plan and able to provide an informed consent;

Exclusion Criteria:

  • Has a primary diagnosis of spinal disorder other than degenerative disc at the involved level;
  • Has a symptomatic disc herniation at more than one lumbar level;
  • Requires a herniectomy at more than one lumbar level;
  • Has a disc degeneration at the treated and adjacent levels > Grade IV (Pfirrmann, 2001);
  • Has a decrease of disc height ≥ 30% as measured by the center of the disc space, and compared to the disc space at the next superior spinal level;
  • Has Modic changes on MRI greater than Grade I at the target level;
  • Has Modic changes on MRI at the adjacent levels;
  • Has an advanced degree of retrolisthesis as shown by lateral X-rays (> 25%, i.e. grade I as per Meyerding);
  • Has a clinical evidence of lysis, antero listhesis or scoliosis (Cobb angle more than 10°);
  • Has signs of segmental instability: more than 4 mm of translation or more than 10° angular motion between adjacent end plates (comparing flexion and extension views);
  • Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta);
  • Has had any previous lumbar spine surgery;
  • Has a Waddell signs of inorganic behaviour score greater than or equal to 3;
  • Has evidence of an active disruptive psychiatric disorder, cognitive impairment or other known condition, significant enough to impact the perception of pain, precludes surgical procedure, clinical evaluation and/or ability to evaluate treatment outcome as determined by investigator;
  • Has a known allergy to silicone, polyethylene, or titanium;
  • Is an alcohol and /or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse;
  • Has obesity defined by BMI greater than or equal to 35;
  • Inability to complete the questionnaires;
  • Planned pregnancy during the course of the study;
  • Previous enrollment into a spine study;
  • Vulnerable patients or unable to exercise free informed consent;
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749996

Locations
Belgium
Cliniques Universitaires Bruxelles Hôpital Erasme
Brussels, Belgium
AZ Sint-Lucas
Gent, Belgium
Hôpital de la Citadelle
Liège, Belgium
AZ Sint-Elisabeth Hospital
Zottegem, Belgium
Czech Republic
University Hospital Olomouc, dept of Neurosurgery
Olomouc, Czech Republic
Germany
Otto-Von-Guericke Universität
Magdeburg, Germany
CA NCH Klinikum rechts der Isar/München
München, Germany
Medizinisches Zentrum Kreis Aachen
Wuerselen, Germany
Italy
Anthea Casa di Cura
Bari, Italy
Istituto Ortopedico Galeazzi
Milan, Italy
Poland
St. Luke Hospital, University of Rzeszow, dept of Neurosurgery
Tarnow, Poland
Spain
Hospital Universitari Bellvitge
Barcelona, Spain
Hospital de León
Leon, Spain
Switzerland
Hôpital Fribourgeois
Fribourg, Switzerland
Hôpitaux Universitaires de Genève
Geneva, Switzerland
Hirslanden Klinik St. Anna
Lucerne, Switzerland
United Kingdom
Chase Farm Hospital
Enfield, United Kingdom
St. Georges Hospital
London, United Kingdom
Greater Manchester Neuroscience Center
Salford, United Kingdom
Sponsors and Collaborators
Medtronic Spinal & Biologics ECA
Investigators
Principal Investigator: Ferdiand Krappel, Dr. Spitalzentrum Oberwallis, Brig
  More Information

No publications provided

Responsible Party: Medtronic Spinal & Biologics ECA
ClinicalTrials.gov Identifier: NCT00749996     History of Changes
Other Study ID Numbers: DIAM™ Study
Study First Received: September 9, 2008
Last Updated: November 22, 2013
Health Authority: Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission
Switzerland: Ethikkommission
Belgium: Institutional Review Board
Italy: Ministry of Health
Italy: Ethics Committee
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Back Pain
Sciatica
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuralgia
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 17, 2014