Swedish Spinal Stenosis Study (SSSS)
|ClinicalTrials.gov Identifier: NCT01994512|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : December 17, 2015
Information provided by (Responsible Party):
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||245 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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 :
- 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 :
- 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.
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