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analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| decompression | Active Comparator | Minimal invasive decompression |
|
| x-stop | Experimental | X-stop, an interspinous decompression device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal invasive decompression | Procedure | foraminotomy, laminotomy, microscopic decompression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Claudication | Zürich Claudication Questionnaire | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| self-evaluated health condition | SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greger Lønne, MD | Norwegian University of Sciense and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nastional Senter for Spinal Disorders | Trondheim | 7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25575084 | Result | Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard OP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.1097/BRS.0000000000000691. | |
| 25608246 | Result | Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, Nygaard OP. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-20. doi: 10.1097/BRS.0000000000000798. |
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| Interspinous Process Decompression (IPD) | Procedure | Interspinous device |
|
|
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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