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Swedish Spinal Stenosis Study (SSSS)

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ClinicalTrials.gov Identifier: NCT01994512
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbar Spinal Stenosis Procedure: Decompression without fusion Procedure: Decompression with fusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.
Study Start Date : October 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Decompression without fusion
Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.
Procedure: Decompression without fusion
Decompressive surgery of both central and lateral component of the stenosis.

Experimental: Decompression with fusion
Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.
Procedure: Decompression with fusion
Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01994512    
Other Study ID Numbers: SS 01
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Keywords provided by Uppsala University:
Spinal stenosis
Decompression
Fusion
Olisthesis
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases