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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.date.accessioned2019-10-04T08:55:35Z
dc.date.available2019-10-04T08:55:35Z
dc.date.issued2019-01-05
dc.description.abstract<p><i>Background - </i>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. <p><i>Methods - </i>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. <p>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. <p><i>Conclusion - </i>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_US
dc.description.sponsorshipWestern Regional Health Authority, Norwayen_US
dc.descriptionSource at <a href=https://doi.org/10.1186/s12891-018-2384-0>https://doi.org/10.1186/s12891-018-2384-0</a>.en_US
dc.identifier.citationAustevoll, I.M., Hermansen, E., Fagerland, M., Rekeland, F., Solberg, T., Storheim, K., ... Hellum, C. (2019). Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial. <i>BMC Musculoskeletal Disorders, 20</i>, 7. https://doi.org/10.1186/s12891-018-2384-0en_US
dc.identifier.cristinIDFRIDAID 1665300
dc.identifier.doi10.1186/s12891-018-2384-0
dc.identifier.issn1471-2474
dc.identifier.urihttps://hdl.handle.net/10037/16325
dc.language.isoengen_US
dc.publisherBMCen_US
dc.relation.journalBMC Musculoskeletal Disorders
dc.rights.accessRightsopenAccessen_US
dc.subjectVDP::Medical disciplines: 700::Clinical medical disciplines: 750::General surgery: 780en_US
dc.subjectVDP::Medisinske Fag: 700::Klinisk medisinske fag: 750::Generell kirurgi: 780en_US
dc.subjectSpinal stenosisen_US
dc.subjectDegenerative spondylolisthesisen_US
dc.subjectRandomized controlled trialen_US
dc.subjectDecompressionen_US
dc.subjectFusionen_US
dc.subjectClinical outcomesen_US
dc.subjectNORDSTENen_US
dc.titleDecompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trialen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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