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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 IM, Hermansen E, Fagerland M, Rekeland F, Solberg T, Storheim K, Brox JI, Lønne G, Indrekvam K, Aaen J, Grundnes O, Hellum C. Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial. BMC Musculoskeletal Disorders. 2019;20:7.eng
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 10years. 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. Trial registration: Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.eng
dc.publisherBioMed Centraleng
dc.rightsAttribution CC BYeng
dc.subjectSpinal stenosiseng
dc.subjectDegenerative spondylolisthesiseng
dc.subjectRandomized controlled trialeng
dc.subjectClinical outcomeseng
dc.titleDecompression alone versusdecompression with instrumental fusionthe NORDSTEN degenerativespondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trialeng
dc.typeJournal articleeng
dc.rights.holderCopyright The Author(s) 2019eng
bora.peerreviewedPeer reviewedeng
dc.type.documentJournal article
dc.relation.journalBMC Musculoskeletal Disorders

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