Randomized Controlled Trial

. 2017 Mar 21;18(1):121.

doi: 10.1186/s12891-017-1491-7.

Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study)

Erland Hermansen^{1

2

3

4}, Ivar Magne Austevoll^{5

6}, Ulla Kristina Romild⁷, Frode Rekeland^{5

6}, Tore Solberg^{8

9

10}, Kjersti Storheim¹¹, Oliver Grundnes¹², Jørn Aaen¹³, Jens Ivar Brox¹⁴, Christian Hellum¹⁴, Kari Indrekvam^{5

6}

Affiliations

¹ Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway. erland.hermansen@helse-bergen.no.
² Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway. erland.hermansen@helse-bergen.no.
³ Department of Clinical Medicine, University of Bergen, Bergen, Norway. erland.hermansen@helse-bergen.no.
⁴ Department of Orthopaedics, Oslo University Hospital, Oslo, Norway. erland.hermansen@helse-bergen.no.
⁵ Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.
⁶ Department of Clinical Medicine, University of Bergen, Bergen, Norway.
⁷ Department of Research, Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway.
⁸ Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway.
⁹ Department of Clinical Medicine, University of Tromsø The Arctic University of Norway, Tromsø, Norway.
¹⁰ Norwegian National Registry for spine surgery, University Hospital of North Norway, Tromsø, Norway.
¹¹ Communication and Research Unit for Musculoskeletal Disorders (FORMI), Oslo University Hospital and University of Oslo, Oslo, Norway.
¹² Department of Orthopedics, Akershus University Hospital, Lørenskog, Norway.
¹³ Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
¹⁴ Department of Physical Medicine and Rehabilitation, University of Oslo, Oslo, Norway.

PMID: 28327114
PMCID: PMC5361830
DOI: 10.1186/s12891-017-1491-7

Randomized Controlled Trial

Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study)

Erland Hermansen et al. BMC Musculoskelet Disord. 2017.

. 2017 Mar 21;18(1):121.

doi: 10.1186/s12891-017-1491-7.

Authors

Affiliations

¹ Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway. erland.hermansen@helse-bergen.no.
² Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway. erland.hermansen@helse-bergen.no.
³ Department of Clinical Medicine, University of Bergen, Bergen, Norway. erland.hermansen@helse-bergen.no.
⁴ Department of Orthopaedics, Oslo University Hospital, Oslo, Norway. erland.hermansen@helse-bergen.no.
⁵ Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.
⁶ Department of Clinical Medicine, University of Bergen, Bergen, Norway.
⁷ Department of Research, Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway.
⁸ Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway.
⁹ Department of Clinical Medicine, University of Tromsø The Arctic University of Norway, Tromsø, Norway.
¹⁰ Norwegian National Registry for spine surgery, University Hospital of North Norway, Tromsø, Norway.
¹¹ Communication and Research Unit for Musculoskeletal Disorders (FORMI), Oslo University Hospital and University of Oslo, Oslo, Norway.
¹² Department of Orthopedics, Akershus University Hospital, Lørenskog, Norway.
¹³ Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
¹⁴ Department of Physical Medicine and Rehabilitation, University of Oslo, Oslo, Norway.

PMID: 28327114
PMCID: PMC5361830
DOI: 10.1186/s12891-017-1491-7

Abstract

Background: There are several posterior decompression techniques for lumbar spinal stenosis (LSS). There is a trend towards performing less invasive surgical procedures, but no multicentre randomized controlled trials have evaluated the relative efficacy of these techniques at short and long-term.

Method/design: A multicentre randomized controlled trial [the Spinal Stenosis Trial (SST) (part of the NORDSTEN study)] including 465 patients aged 18-80 years with neurogenic claudication or radiating pain and MRI findings indicating lumbar spinal stenosis without spondylolisthesis is performed to compare three posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy and spinous process osteotomy. The primary outcome is change in Oswestry Disability Index (ODI 2 years postoperatively). Secondary outcomes are change in EQ-5D, Zurich Claudication Questionnaire, and Numeric Rating Scale for leg-pain and back-pain. Also recorded were Global Perceived Effect score, complications, length of hospital stay, reoperation rate 2 years postoperatively, difference in recurrence of symptoms or postoperative instability, and MRI change in the dural sac area. Further, a 5 and 10 years follow-up is planned with the same outcome measures.

Discussion: Newer and less invasive techniques are increasingly favoured in surgery for LSS. This trial will compare the clinical and radiological results of three different techniques, and may contribute to better clinical decision making in the surgical treatment of LSS.

Trial registration: ClinicalTrials.gov reference: NCT02007083 (November 22, 2013).

Keywords: Laminotomy; Lumbar spinal stenosis; Osteotomy; Randomized controlled trial; Surgical treatment.

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Figures

**Fig. 1**
Patient flow through the trial. (PROM: Patient Reported Outcome Measures)

See this image and copyright information in PMC

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Dural Sac Cross-sectional area change from preoperatively and up to 2 years after decompressive surgery for central lumbar spinal stenosis: investigation of operated levels, data from the NORDSTEN study.
Hermansen E, Myklebust TÅ, Austevoll IM, Hellum C, Storheim K, Banitalebi H, Indrekvam K, Brisby H. Hermansen E, et al. Eur Spine J. 2024 Jun;33(6):2234-2241. doi: 10.1007/s00586-024-08251-4. Epub 2024 Apr 8. Eur Spine J. 2024. PMID: 38587545 Clinical Trial.
Navigated minimally invasive unilateral laminotomy with crossover for intraoperative prediction of outcome in degenerative lumbar stenosis.
Cardali SM, Cacciola F, Raffa G, Conti A, Caffo M, Germanò A. Cardali SM, et al. J Craniovertebr Junction Spine. 2018 Apr-Jun;9(2):107-115. doi: 10.4103/jcvjs.JCVJS_45_18. J Craniovertebr Junction Spine. 2018. PMID: 30008529 Free PMC article.
The Norwegian degenerative spondylolisthesis and spinal stenosis (NORDSTEN) study: study overview, organization structure and study population.
Indrekvam K, Bånerud IF, Hermansen E, Austevoll IM, Rekeland F, Guddal MH, Solberg TK, Brox JI, Hellum C, Storheim K. Indrekvam K, et al. Eur Spine J. 2023 Dec;32(12):4162-4173. doi: 10.1007/s00586-023-07827-w. Epub 2023 Jul 3. Eur Spine J. 2023. PMID: 37395780

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Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study)

Affiliations

Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study)

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