Swedish Spinal Stenosis Study

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Procedure: Decompression without fusion; Procedure: Decompression with fusion

• Registration Number: NCT01994512
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2012-06
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Study Completion: 2014-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decompression without fusion	Decompression without fusion	Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.
Decompression with fusion	Decompression with fusion	Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	2 years	A difference in ODI of 12 at follow up between the two interventions is considered as significant.

Secondary Outcome Measures

Name	Time	Method
EuroQol (EQ-5D)	2 years	Measurement of quality of life
Back pain	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	2 years	The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
Swiss Spinal Stenosis Questionnaire	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.