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| Sponsor: | Medtronic Spine LLC |
|---|---|
| Information provided by (Responsible Party): | Medtronic Spine LLC |
| ClinicalTrials.gov Identifier: | NCT00558129 |
Purpose
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.
| Condition | Intervention | Phase |
|---|---|---|
|
Lumbar Spinal Stenosis |
Device: X-STOP® Procedure: Laminectomy |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Trial Comparing X-STOP® Interspinous Process Decompression® System Versus Laminectomy for Treatment of Neurogenic Intermittent Claudication |
| Enrollment: | 0 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2011 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational
X-STOP® PEEK IPD
|
Device: X-STOP®
Surgical implantation of X-STOP IPD device
Other Name: X-STOP® PEEK IPD
|
|
Active Comparator: Control
Laminectomy
|
Procedure: Laminectomy
Standard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment.
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The clinical study described herein aims to compare surgical outcomes of X-STOP® Interspinous Process Decompression® (IPD) system implantation and conventional laminectomy in subjects requiring surgical intervention due to symptoms of lumbar spinal stenosis (LSS) and a confirmed diagnosis on MRI, X-ray or CT. Patients with LSS meeting entry criteria will be randomized to either X-STOP® IPD or laminectomy treatment. Patients will remain blinded to the procedure received. The primary study outcome is group differences in the Zurich Claudication Questionnaire (ZCQ) at 12 months post-operative. In addition, each subject will undergo follow-up assessment at 2 weeks and 2, 12 and 24 months post-operative. The secondary objective is to compare safety profiles and the radiographic outcomes between groups using pre- and post-operative MRI and flexion/extension X-rays, to measure changes in canal and neuroforaminal cross sectional areas and spinal stability, respectively.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Medtronic Spine LLC |
| ClinicalTrials.gov Identifier: | NCT00558129 History of Changes |
| Other Study ID Numbers: | LSS0702 |
| Study First Received: | November 12, 2007 |
| Last Updated: | January 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
|
Lumbar Spinal Stenosis X-STOP® IPD Interspinous process decompression Neurogenic Intermittent Claudication |
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Constriction, Pathologic Intermittent Claudication Spinal Stenosis Pathological Conditions, Anatomical Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Signs and Symptoms Spinal Diseases Bone Diseases Musculoskeletal Diseases |