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).
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.



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.



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.



ClinicalTrials.gov reference: NCT02007083 (November 22, 2013).
Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway. erland.hermansen@helse-bergen.no.|Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway. erland.hermansen@helse-bergen.no.|Department of Clinical Medicine, University of Bergen, Bergen, Norway. erland.hermansen@helse-bergen.no.|Department of Orthopaedics, Oslo University Hospital, Oslo, Norway. erland.hermansen@helse-bergen.no.
Erland
0000-0003-0956-5035
E
Hermansen
Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.|Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Ivar Magne
IM
Austevoll
Department of Research, Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway.
Ulla Kristina
UK
Romild
Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.|Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Frode
F
Rekeland
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.
Tore
T
Solberg
Communication and Research Unit for Musculoskeletal Disorders (FORMI), Oslo University Hospital and University of Oslo, Oslo, Norway.
Kjersti
K
Storheim
Department of Orthopedics, Akershus University Hospital, Lørenskog, Norway.
Oliver
O
Grundnes
Department of Orthopedic Surgery, Ålesund Hospital, Møre and Romsdal Hospital Trust, Ålesund, Norway.
Jørn
J
Aaen
Department of Physical Medicine and Rehabilitation, University of Oslo, Oslo, Norway.
Jens Ivar
JI
Brox
Department of Physical Medicine and Rehabilitation, University of Oslo, Oslo, Norway.
Christian
C
Hellum
Kysthospitalet in Hagevik, Orthopedic Clinic, Haukeland University Hospital, Bergen, Norway.|Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Kari
K
Indrekvam
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001696:Biomechanical Phenomena; D002985:Clinical Protocols; D019299:Decompression, Surgical / Q000009:adverse effects / Q000379:methods*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007796:Laminectomy / Q000009:adverse effects; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009664:Norway; D010027:Osteotomy / Q000009:adverse effects; D010147:Pain Measurement; D020127:Recovery of Function; D012107:Research Design; D013130:Spinal Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
Laminotomy; Lumbar spinal stenosis; Osteotomy; Randomized controlled trial; Surgical treatment