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).

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).

• Authors: Erland Hermansen, Ivar Magne Austevoll, Ulla Kristina Romild, Frode Rekeland, Tore Solberg, Kjersti Storheim, Oliver Grundnes, Jørn Aaen, Jens Ivar Brox, Christian Hellum, Kari Indrekvam
• Journal: BMC musculoskeletal disorders (BMC Musculoskelet Disord) Vol. 18 Issue 1 Pg. 121 (03 21 2017) ISSN: 1471-2474 [Electronic] England
• PMID: 28327114 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Biomechanical Phenomena
• Clinical Protocols
• Decompression, Surgical (adverse effects, methods)
• Disability Evaluation
• Female
• Humans
• Laminectomy (adverse effects)
• Lumbar Vertebrae (diagnostic imaging, physiopathology, surgery)
• Magnetic Resonance Imaging
• Male
• Middle Aged
• Norway
• Osteotomy (adverse effects)
• Pain Measurement
• Recovery of Function
• Research Design
• Spinal Stenosis (diagnostic imaging, physiopathology, surgery)
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome
• Young Adult