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

BMC Musculoskeletal Disorders

Kari Indrekvam¹  Jørn Aaen¹  Tore Solberg²  Greger Lønne³  Oliver Grundnes⁴  Jens Ivar Brox⁵  Christian Hellum⁶  Erland Hermansen⁷  Ivar Magne Austevoll⁷  Frode Rekeland⁷  Morten Fagerland⁸  Kjersti Storheim⁹ 

[1] Department of Clinical Medicine, University of Bergen;Department of Neurosurgery, University Hospital of Northern Norway;Department of Orthopedic Surgery, Innlandet Hospital Trust;Department of Orthopedics, Akershus University Hospital;Department of Physical Medicine and Rehabilitation, Oslo University Hospital;Division of Orthopaedic Surgery, Oslo University Hospital;Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital;Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital;Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital;

关键词: Spinal stenosis;    Degenerative spondylolisthesis;    Randomized controlled trial;    Decompression;    Fusion;    Clinical outcomes;   

DOI  :  10.1186/s12891-018-2384-0

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown