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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

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date December 17, 2015
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • 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.
  • 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.
  • EuroQol (EQ-5D) [ Time Frame: 2 years ]
    Measurement of quality of life
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • 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.
  • 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.
  • EuroQol (EQ-5D) [ Time Frame: 2 years ]
    Measurement of quality of life
  • SF-36 [ Time Frame: 2 years ]
    The Short Form (36) Health Survey is a patient-reported survey of patient health.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Swedish Spinal Stenosis Study
Official Title  ICMJE Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lumbar Spinal Stenosis
Intervention  ICMJE
  • Procedure: Decompression without fusion
    Decompressive surgery of both central and lateral component of the stenosis.
  • 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.
Study Arms  ICMJE
  • Experimental: Decompression without fusion
    Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.
    Intervention: Procedure: Decompression without fusion
  • Experimental: Decompression with fusion
    Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.
    Intervention: Procedure: Decompression with fusion
Publications * Försth P, Ólafsson G, Carlsson T, Frost A, Borgström F, Fritzell P, Öhagen P, Michaëlsson K, Sandén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 22, 2013)
245
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994512
Other Study ID Numbers  ICMJE SS 01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Uppsala University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP