Study 18 of 26 for search of: "Sciatica"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
This study is currently recruiting participants.
Verified by Medtronic Spine, Biologics & Navigation, September 2008
Sponsored by: Medtronic Spine, Biologics & Navigation
Information provided by: Medtronic Spine, Biologics & Navigation
ClinicalTrials.gov Identifier: NCT00749996
  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
Lumbar Degenerative Disc Disease
Device: DIAM™ Spinal Stabilization System
Procedure: Herniectomy
Phase IV

MedlinePlus related topics: Sciatica
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Herniectomy vs. Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease

Further study details as provided by Medtronic Spine, Biologics & Navigation:

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 ]

Estimated Enrollment: 268
Study Start Date: November 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: 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.
2: 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.

  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 Modic16 changes on MRI greater than Grade I at the target level;
  • Has Modic16 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

Contacts
Contact: Liliana Rincon Kohli +41 21 803 8042 liliana.rincon.kohli@medtronic.com

Locations
Belgium
AZ Sint-Lucas Recruiting
Gent, Belgium
Principal Investigator: Giovanni Alessi, MD            
Cliniques Universitaires Bruxelles Hôpital Erasme Recruiting
Brussels, Belgium
Principal Investigator: Oliver De Witte, MD            
Hôpital de la Citadelle Recruiting
Liege, Belgium
Principal Investigator: Jean-Michel Remacle, MD            
Germany
Otto-von-Guericke Universität Recruiting
Magdeburg, Germany
Principal Investigator: Boris Jöllenbeck, MD            
Klinikum rechts der Isar der Technischen Universität München Recruiting
Munich, Germany
Principal Investigator: Bernhard Meyer, MD, Prof.            
Medizinisches Zentrum Kreis Aachen Recruiting
Wuerselen, Germany
Principal Investigator: Ferdinand A. Krappel, MD            
Italy
Istituto Ortopedico Galeazzi Recruiting
Milan, Italy
Principal Investigator: Marco Brayda-Bruno, MD            
Anthea Casa di Cura Recruiting
Bari, Italy
Principal Investigator: Antonello Ceddia, MD            
Villa Maria Pia Hospital Not yet recruiting
Turin, Italy
Principal Investigator: Antonio Fabrizi, MD            
Spain
Hospital Universitari Bellvitge Recruiting
Barcelona, Spain
Principal Investigator: Juan J. Acebes, MD            
Hospital de León Recruiting
Leon, Spain
Principal Investigator: Javier Fernández, MD            
Switzerland
Hôpital Fribourgeois Recruiting
Fribourg, Switzerland
Principal Investigator: Gianluca Maestretti, MD            
Hirslanden Klinik St. Anna Recruiting
Lucerne, Switzerland
Principal Investigator: Oliver Hausmann, MD, PD            
Hôpitaux Universitaires de Genève Active, not recruiting
Geneva, Switzerland
United Kingdom
St. Georges Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Jason Bernard, MD            
Chase Farm Hospital Recruiting
Enfield, United Kingdom
Principal Investigator: Timothy Bull, MD            
Wellington Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Lester Wilson, MD            
Sponsors and Collaborators
Medtronic Spine, Biologics & Navigation
Investigators
Principal Investigator: Ferdinand A. Krappel, MD Medizinisches Zentrum Kreis Aachen
  More Information

Responsible Party: Medtronic Spine, Biologics and Navigation ( Medtronic Europe Sàrl )
Study ID Numbers: DIAM™ Study
Study First Received: September 9, 2008
Last Updated: September 14, 2008
ClinicalTrials.gov Identifier: NCT00749996  
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

Study placed in the following topic categories:
Spinal Diseases
Sciatica
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on January 16, 2009