Swedish Spinal Stenosis Study

N/ACompletedNCT01994512

Uppsala University245 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Lumbar Spinal Stenosis

Interventions

Decompression without fusionPROCEDURE

Decompressive surgery of both central and lateral component of the stenosis.

Decompression with fusionPROCEDURE

Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

A difference in ODI of 12 at follow up between the two interventions is considered as significant.

Time frame: 2 years

Secondary Outcomes

Back pain

The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.

Time frame: 2 years

Leg pain

The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.

Time frame: 2 years

EuroQol (EQ-5D)

Measurement of quality of life

Time frame: 2 years

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.

Time frame: 2 years

Data from ClinicalTrials.gov

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