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dc.contributor.authorAustevoll, Ivar Magneen_US
dc.contributor.authorHermansen, Erlanden_US
dc.contributor.authorFagerland, Mortenen_US
dc.contributor.authorRekeland, Frodeen_US
dc.contributor.authorSolberg, Toreen_US
dc.contributor.authorStorheim, Kjerstien_US
dc.contributor.authorBrox, Jens Ivaren_US
dc.contributor.authorLønne, Gregeren_US
dc.contributor.authorIndrekvam, Karien_US
dc.contributor.authorAaen, Jørnen_US
dc.contributor.authorGrundnes, Oliveren_US
dc.contributor.authorHellum, Christianen_US
dc.date.accessioned2019-09-10T09:17:50Z
dc.date.available2019-09-10T09:17:50Z
dc.date.issued2019-01-05
dc.PublishedAustevoll 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.identifier.issn1471-2474
dc.identifier.urihttps://hdl.handle.net/1956/20811
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: ClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.en_US
dc.language.isoengeng
dc.publisherBioMed Centraleng
dc.rightsAttribution CC BYeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/eng
dc.subjectSpinal stenosiseng
dc.subjectDegenerative spondylolisthesiseng
dc.subjectRandomized controlled trialeng
dc.subjectDecompressioneng
dc.subjectFusioneng
dc.subjectClinical outcomeseng
dc.subjectNORDSTENeng
dc.titleDecompression alone versusdecompression with instrumental fusionthe NORDSTEN degenerativespondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trialen_US
dc.typePeer reviewed
dc.typeJournal article
dc.date.updated2019-08-05T09:22:39Z
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright The Author(s) 2019
dc.identifier.doihttps://doi.org/10.1186/s12891-018-2384-0
dc.identifier.cristin1665300
dc.source.journalBMC Musculoskeletal Disorders


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