Abstract
BackgroundFusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. The present protocol describes an ongoing study with the primary aim of comparing the outcome between decompression alone and decompression with instrumented fusion. The secondary aim is to investigate whether predictors can be used to choose the best treatment for an individual. The trial, named the NORDSTEN-DS trial, is one of three studies in the Norwegian Degenerative Spinal Stenosis (NORDSTEN) study.MethodsThe NORDSTEN-DS trial is a block-randomized, controlled, multicenter, non-inferiority study with two parallel groups. The surgeons at the 15 participating hospitals decide whether a patient is eligible or not according to the inclusion and exclusion criteria. Participating patients are randomized to either a midline preserving decompression or a decompression followed by an instrumental fusion.Primary endpoint is the percentage of patients with an improvement in Oswestry Disability Index version 2.0 of more than 30% from baseline to 2-year follow-up. Secondary outcome measurements are the Zürich Claudication Questionnaire, Numeric Rating Scale for back and leg pain, Euroqol 5 dimensions questionnaire, Global perceived effect scale, complications and several radiological parameters. Analysis and interpretation of results will also be conducted after 5 and 10 years.ConclusionThe NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not. Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group.Trial registrationClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.
Highlights
Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS)
The NORDSTEN/DS trial has the potential to provide Level 1 evidence of whether decompression alone should be advocated as the preferred method or not
Further on the study will investigate whether predictors exist and if they can be used to make the appropriate choice for surgical treatment for this patient group
Summary
Fusion in addition to decompression has become the standard treatment for lumbar spinal stenosis with degenerative spondylolisthesis (DS). The evidence for performing fusion among these patients is conflicting and there is a need for further investigation through studies of high quality. Lumbar degenerative spondylolisthesis (LDS) is the forward slip of one vertebra over another caused by degeneration and instability of facet joints, and degeneration of ligaments and intervertebral discs [1]. Most patients suffer from symptoms related to a concomitant spinal stenosis, such as back pain, radiating pain to the lower extremities, and, typically, increased pain when walking upright and decreased pain when bending forward [2, 3]. Several cohort studies [9,10,11] and another recently published RCT [12], have introduced evidence against additional fusion when operating for LDS
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