Lumbar Spinal Stenosis
Conditions
Keywords
Spinal stenosis, Decompression, Fusion, Olisthesis
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.
Interventions
PROCEDUREDecompression without fusion
Decompressive surgery of both central and lateral component of the stenosis.
PROCEDUREDecompression with fusion
Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 2 years | A difference in ODI of 12 at follow up between the two interventions is considered as significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed