Evidence map›Paper›PMID 30611229›Full record

ArticleBMC musculoskeletal disorders2019

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

Ivar Magne Austevoll, Erland Hermansen, Morten Fagerland, Frode Rekeland, Tore Solberg, Kjersti Storheim, Jens Ivar Brox, Greger Lønne, Kari Indrekvam, Jørn Aaen and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC musculoskeletal disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02051374 (Degenerative Lumbar Spondylolisthesis), which is not on this map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02051374 naactive not recruitingnot on this map

Degenerative Lumbar Spondylolisthesis: Is Only Decompression Good Enough? A Prospective Randomized Clinical Multi- Institutional Trial

TypeinterventionalSponsorHaukeland University HospitalRan2014 to 2028Enrolled267ConditionsLumbar Degenerative SpondylolisthesisArmsDecompression alone, Decompression followed by fusion with instrumentation
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Clinical and MRI findings in lumbar spinal stenosis: baseline data from the NORDSTEN study.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022
    Trial
  5. Radiographic phenotype-driven clustering in lumbar decompression: comparative study of outcome and reoperation risk.The spine journal : official journal of the North American Spine Society · 2026
    Article
  6. Article
  7. Article
  8. The Norwegian degenerative spondylolisthesis and spinal stenosis (NORDSTEN) study: study overview, organization structure and study population.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2023
    Article
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Ivar Magne AustevollKysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Hagavik, N- 5217, Bergen, Norway. imau@helse-bergen.no.
Erland HermansenKysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Hagavik, N- 5217, Bergen, Norway.
Morten FagerlandOslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, N-0424, Oslo, Norway.
Frode RekelandKysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Hagavik, N- 5217, Bergen, Norway.
Tore SolbergDepartment of Neurosurgery, University Hospital of Northern Norway, N-9019, Tromsø, Norway.
Kjersti StorheimResearch and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital, N-0424, Oslo, Oslo, Norway.
Jens Ivar BroxDepartment of Physical Medicine and Rehabilitation, Oslo University Hospital, N-0424, Oslo, Norway.
Greger LønneDepartment of Orthopedic Surgery, Innlandet Hospital Trust, N-2609, Lillehammer, Lillehammer, Norway.
Kari IndrekvamDepartment of Clinical Medicine, University of Bergen, N- 5007, Bergen, Norway.
Jørn AaenDepartment of Clinical Medicine, University of Bergen, N- 5007, Bergen, Norway.
Oliver GrundnesDepartment of Orthopedics, Akershus University Hospital, N-1474, Lørenskog, Oslo, Norway.
Christian HellumDivision of Orthopaedic Surgery, Oslo University Hospital, N-0424, Oslo, Norway.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFusion 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.

methodsThe 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.

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

Indexed as

Decompression, SurgicalDisability EvaluationEquivalence Trials as TopicHumansMulticenter Studies as TopicNorwayPain MeasurementRecovery of FunctionSpinal FusionSpinal StenosisSpondylolisthesisTime FactorsTreatment OutcomeClinical outcomesDecompressionDegenerative spondylolisthesisFusionNORDSTENRandomized controlled trialSpinal stenosis

Identifiers

PMID30611229
PMCPMC6320633

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.