Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop

Study Overview
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Brief Summary
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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)

Official Title
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Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)

Conditions
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Lumbar Spinal Stenosis, Radiculopathy

Intervention / Treatment
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* Procedure: Minimal invasive decompression
* Procedure: Interspinous Process Decompression (IPD)


Participation Criteria
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Eligibility Criteria
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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 clinical and radiological (both) arthritis in the hip joint ASA >3 verified polyneuropathy on neurophysiological test

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: decompression<br>Minimal invasive decompression | Procedure: Minimal invasive decompression<br>* foraminotomy, laminotomy, microscopic decompression<br>* Other names: mini-invasive decompression;|
| Experimental: x-stop<br>X-stop, an interspinous decompression device | Procedure: Interspinous Process Decompression (IPD)<br>* Interspinous device<br>* Other names: X-stop;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Claudication | Zürich Claudication Questionnaire | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-evaluated health condition | SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decompression, Surgical, x-stop, lumbar decompression, spinal stenosis, radiculopathy