Swedish Spinal Stenosis Study

Lumbar Spinal Stenosis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994512
• Other study ID #: SS 01
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: December 16, 2015
• Start date: October 2006
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish Research Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: June 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Decompression without fusion
Decompressive surgery of both central and lateral component of the stenosis.
• Decompression with fusion
Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	A difference in ODI of 12 at follow up between the two interventions is considered as significant.	2 years	No
Secondary	Back pain	The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.	2 years	No
Secondary	Leg pain	The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.	2 years	No
Secondary	EuroQol (EQ-5D)	Measurement of quality of life	2 years	No
Secondary	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.	2 years	No