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Sponsored by: |
Medtronic Spine, Biologics & Navigation |
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Information provided by: | Medtronic Spine, Biologics & Navigation |
ClinicalTrials.gov Identifier: | NCT00749996 |
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 |
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Sciatica Lumbar Degenerative Disc Disease |
Device: DIAM™ Spinal Stabilization System Procedure: Herniectomy |
Phase IV |
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 |
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 |
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1: Experimental
Investigational group: single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
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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.
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2: Active Comparator
Control group: single level herniectomy
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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.
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Ages Eligible for Study: | 20 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Liliana Rincon Kohli | +41 21 803 8042 | liliana.rincon.kohli@medtronic.com |
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 |
Principal Investigator: | Ferdinand A. Krappel, MD | Medizinisches Zentrum Kreis Aachen |
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 |
Spinal Diseases Sciatica Musculoskeletal Diseases Bone Diseases |