Swedish Spinal Stenosis Study (SSSS)

December 16, 2015 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
EuroQol (EQ-5D)
Time Frame: 2 years
Measurement of quality of life
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SS 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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