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)

BMC Musculoskeletal Disorders

Study Protocol

Kjersti Storheim¹  Tore Solberg²  Jørn Aaen³  Erland Hermansen⁴  Oliver Grundnes⁵  Jens Ivar Brox⁶  Christian Hellum⁶  Ulla Kristina Romild⁷  Ivar Magne Austevoll⁸  Frode Rekeland⁸  Kari Indrekvam⁸ 

[1] Communication and Research Unit for Musculoskeletal Disorders (FORMI), Oslo University Hospital and University of Oslo, Oslo, Norway;Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway;Department of Clinical Medicine, University of Tromsø The Arctic University of Norway, Tromsø, Norway;Norwegian National Registry for spine surgery, University Hospital of North Norway, Tromsø, Norway;Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway;Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway;Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway;Department of Clinical Medicine, University of Bergen, Bergen, Norway;Department of Orthopaedics, Oslo University Hospital, Oslo, Norway;Department of Orthopedics, Akershus University Hospital, Lørenskog, Norway;Department of Physical Medicine and Rehabilitation, University of Oslo, Oslo, Norway;Department of Research, Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway;Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway;Department of Clinical Medicine, University of Bergen, Bergen, Norway;

关键词: Randomized controlled trial;    Lumbar spinal stenosis;    Surgical treatment;    Laminotomy;    Osteotomy;   

DOI  :  10.1186/s12891-017-1491-7

 received in 2016-11-25, accepted in 2017-03-15,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThere 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/designA 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.DiscussionNewer 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 registrationClinicalTrials.gov reference: NCT02007083 (November 22, 2013).

【 授权许可】

CC BY   
© The Author(s). 2017