An interventional study of Decompression without fusion and Decompression with fusion in Lumbar Spinal Stenosis, sponsored by Uppsala University. Completed. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-17.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 245 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion.
Procedure: Decompression without 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.
Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.
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
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
No study locations are listed for this record.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Uppsala University