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Open Access 01-12-2019 | Spondylolisthesis | Study protocol

Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial

Authors: Ivar Magne Austevoll, Erland Hermansen, Morten Fagerland, Frode Rekeland, Tore Solberg, Kjersti Storheim, Jens Ivar Brox, Greger Lønne, Kari Indrekvam, Jørn Aaen, Oliver Grundnes, Christian Hellum

Published in: BMC Musculoskeletal Disorders | Issue 1/2019

Abstract

Background

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.

Trial registration

ClinicalTrials.gov Identifier: NCT02051374. First Posted: January 31, 2014. Last Update Posted: February 14, 2018.

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Title: Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial
Authors: Ivar Magne Austevoll
Erland Hermansen
Morten Fagerland
Frode Rekeland
Tore Solberg
Kjersti Storheim
Jens Ivar Brox
Greger Lønne
Kari Indrekvam
Jørn Aaen
Oliver Grundnes
Christian Hellum
Publication date: 01-12-2019
Publisher: BioMed Central
Keywords: Spondylolisthesis
Spinal Stenosis
Published in: BMC Musculoskeletal Disorders / Issue 1/2019
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-018-2384-0

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Decompression alone versus decompression with instrumental fusion the NORDSTEN degenerative spondylolisthesis trial (NORDSTEN-DS); study protocol for a randomized controlled trial

Abstract

Background

Methods

Conclusion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Conclusion

Trial registration

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