NCT00546949
Terminated
Not Applicable
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lumbar Spinal Stenosis
- Sponsor
- Norwegian University of Science and Technology
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Claudication
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)
Investigators
Eligibility Criteria
Inclusion Criteria
- •neurogenic intermittent claudication due to lumbar spinal stenosis
- •diagnosed on MRI in maximum two levels
- •walking distance on 250 metres
- •symptom relief on flexion of the lumbar spine
- •duration of the symptoms more than 6 months
- •non-operative treatment is tried or considered as not indicated
Exclusion Criteria
- •vascular claudicatio intermittens
- •spinal stenosis on more than 2 levels
- •cauda equina syndrome
- •severe paresis
- •clinical monoradiculopathy
- •grave scoliosis
- •previous lumbar surgery
- •degenerative spondylolisthesis more than 25%
- •spondylolysis with listhesis
- •osteoporotic fracture in lumbal column
Outcomes
Primary Outcomes
Claudication
Time Frame: 2 years
Zürich Claudication Questionnaire
Secondary Outcomes
- self-evaluated health condition(2 years)
Study Sites (1)
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