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Completed

NCT Number: NCT01994512

Swedish Spinal Stenosis Study

A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis Spondylolisthesis Spondylolysis Spondylosis

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pseudoclaudication in one or both legs and backpain (VAS>30)
  • MRI with 1-2 adjacent stenotic segments (area <0.75 mm2)between L2 and sacrum
  • Duration of symptoms >6 months
  • Informed consent

Exclusion criteria

  • Spondylolysis
  • Degenerative lumbar scoliosis (Cobb angle >20 deg)
  • History of lumbar spinal surgery for spinal stenosis or instability
  • Stenosis not caused by degenerative changes
  • Stenosis caused by herniated disc
  • Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders
  • History of vertebral compression fractures in affected segments
  • Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)

Treatment and study plan

Decompression without fusion

Procedure

Decompressive surgery of both central and lateral component of the stenosis.

Decompression with fusion

Procedure

Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 2 years

    A difference in ODI of 12 at follow up between the two interventions is considered as significant.

Secondary outcomes

  1. Back pain

    Time frame: 2 years

    The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.

  2. Leg pain

    Time frame: 2 years

    The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.

  3. EuroQol (EQ-5D)

    Time frame: 2 years

    Measurement of quality of life

  4. Swiss Spinal Stenosis Questionnaire

    Time frame: 2 years

    A disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis. The Swiss Spinal Stenosis Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with lumbar spinal stenosis.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.

Acronym: SSSS

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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