Herniectomy Versus Herniectomy With a Spinal Stabilization System for the Treatment of Complex Disc Disease
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.
Device: DIAM™ Spinal Stabilization System
|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|
- 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 ]The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.
- 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 ]
The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI).
The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability.
|Study Start Date:||November 2006|
|Study Completion Date:||June 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749996
|Cliniques Universitaires Bruxelles Hôpital Erasme|
|Hôpital de la Citadelle|
|AZ Sint-Elisabeth Hospital|
|University Hospital Olomouc, dept of Neurosurgery|
|Olomouc, Czech Republic|
|CA NCH Klinikum rechts der Isar/München|
|Medizinisches Zentrum Kreis Aachen|
|Anthea Casa di Cura|
|Istituto Ortopedico Galeazzi|
|St. Luke Hospital, University of Rzeszow, dept of Neurosurgery|
|Hospital Universitari Bellvitge|
|Hospital de León|
|Hôpitaux Universitaires de Genève|
|Hirslanden Klinik St. Anna|
|Chase Farm Hospital|
|Enfield, United Kingdom|
|St. Georges Hospital|
|London, United Kingdom|
|Greater Manchester Neuroscience Center|
|Salford, United Kingdom|
|Principal Investigator:||Ferdiand Krappel, Dr.||Spitalzentrum Oberwallis, Brig|