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dc.contributor.authorAustevoll, Ivar Magne
dc.contributor.authorHermansen, Erland
dc.contributor.authorFagerland, Morten
dc.contributor.authorRekeland, Frode
dc.contributor.authorSolberg, Tore
dc.contributor.authorStorheim, Kjersti
dc.contributor.authorBrox, Jens Ivar
dc.contributor.authorLønne, Greger
dc.contributor.authorIndrekvam, Kari
dc.contributor.authorAaen, Jørn
dc.contributor.authorGrundnes, Oliver
dc.contributor.authorHellum, Christian
dc.identifier.citationAustevoll, I. M., et al. (2019). "Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial." BMC Musculoskelet Disord 20(1): 7.en
dc.description.abstractBACKGROUND: 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. 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. METHODS: The 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. CONCLUSION: 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.en
dc.description.sponsorshipHelse Vest RHF (the Western Regional Health Authority) has provided funds for the present study. The funder has no influence on study design, management and interpretation of data or the decision to submit data.en
dc.rightsNavngivelse 4.0 Internasjonal*
dc.subjectSpinal stenosis, Degenerative spondylolisthesis, Randomized controlled trial, Decompression, Fusion, Clinical outcomes, NORDSTENen
dc.titleDecompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trialen
dc.rights.holder© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
dc.source.journalBMC Musculoskeletal Disordersen
cristin.unitnameDiv Lillehammer

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