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Swedish Spinal Stenosis Study (SSSS)

Primary Purpose

Lumbar Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decompression without fusion
Decompression with fusion
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Spinal Stenosis focused on measuring Spinal stenosis, Decompression, Fusion, Olisthesis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Decompression without fusion

    Decompression with fusion

    Arm Description

    Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.

    Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.

    Outcomes

    Primary Outcome Measures

    Oswestry Disability Index (ODI)
    A difference in ODI of 12 at follow up between the two interventions is considered as significant.

    Secondary Outcome Measures

    Back pain
    The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
    Leg pain
    The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
    EuroQol (EQ-5D)
    Measurement of quality of life
    Swiss Spinal Stenosis Questionnaire
    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.

    Full Information

    First Posted
    November 19, 2013
    Last Updated
    December 16, 2015
    Sponsor
    Uppsala University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01994512
    Brief Title
    Swedish Spinal Stenosis Study
    Acronym
    SSSS
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Uppsala University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Spinal Stenosis
    Keywords
    Spinal stenosis, Decompression, Fusion, Olisthesis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    245 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Decompression without fusion
    Arm Type
    Experimental
    Arm Description
    Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.
    Arm Title
    Decompression with fusion
    Arm Type
    Experimental
    Arm Description
    Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.
    Intervention Type
    Procedure
    Intervention Name(s)
    Decompression without fusion
    Intervention Description
    Decompressive surgery of both central and lateral component of the stenosis.
    Intervention Type
    Procedure
    Intervention Name(s)
    Decompression with fusion
    Intervention Description
    Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.
    Primary Outcome Measure Information:
    Title
    Oswestry Disability Index (ODI)
    Description
    A difference in ODI of 12 at follow up between the two interventions is considered as significant.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Back pain
    Description
    The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
    Time Frame
    2 years
    Title
    Leg pain
    Description
    The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
    Time Frame
    2 years
    Title
    EuroQol (EQ-5D)
    Description
    Measurement of quality of life
    Time Frame
    2 years
    Title
    Swiss Spinal Stenosis Questionnaire
    Description
    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.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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)

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27074066
    Citation
    Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.
    Results Reference
    derived

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