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| Sponsor: | Norwegian University of Science and Technology |
|---|---|
| Information provided by: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00546949 |
Purpose
The purpose of this study is to compare two operation methods on lumbar spinal stenosis; minimal invasive decompression to X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and nevrogenic intermittent claudicatio.
| Condition | Intervention |
|---|---|
|
Lumbar Spinal Stenosis Radiculopathy Decompression, Surgical |
Procedure: Minimal invasive decompression Procedure: Interspinous Process Decompression (IPD) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS) |
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Minimal invasive decompression
|
Procedure: Minimal invasive decompression
foraminotomy, arcotomy, microscopic decompression
Other Name: mini-invasive decompression
|
|
Active Comparator: 2
X-stop, an interspinous decompression device
|
Procedure: Interspinous Process Decompression (IPD)
Interspinous device
Other Name: X-stop
|
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Øystein Nygaard, PhD | +4773866687 | oystein.nygaard@ntnu.no |
| Contact: Hege Andresen | +4790205421 | Hege.Andresen@stolav.no |
| Norway | |
| Nastional Senter for Spinal Disorders | Recruiting |
| Trondheim, Norway, 7006 | |
| Contact: Øystein Nygaard, PhD +4773866687 oystein.nygaard@ntnu.no | |
| Principal Investigator: | Greger Lønne, MD | Norwegian University of Sciense and Technology |
More Information
| Responsible Party: | Oystein Nygaard, Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00546949 History of Changes |
| Other Study ID Numbers: | NSSL-16279 |
| Study First Received: | October 18, 2007 |
| Last Updated: | August 9, 2011 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
|
x-stop lumbar decompression spinal stenosis radiculopathy |
|
Constriction, Pathologic Spinal Stenosis Radiculopathy Pathological Conditions, Anatomical Spinal Diseases |
Bone Diseases Musculoskeletal Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |