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Sponsored by: |
Medtronic Spine LLC |
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Information provided by: | Medtronic Spine LLC |
ClinicalTrials.gov Identifier: | NCT00558129 |
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 |
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Lumbar Spinal Stenosis |
Device: X-STOP® Procedure: Laminectomy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Trial Comparing X-STOP® Interspinous Process Decompression® System Versus Laminectomy for Treatment of Neurogenic Intermittent Claudication |
Estimated Enrollment: | 154 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2011 |
Arms | Assigned Interventions |
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1: Experimental
X-STOP® PEEK IPD
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Device: X-STOP®
Surgical implantation of X-STOP IPD device
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2: Active Comparator
Laminectomy
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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.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Longhi | 408-548-6542 | michael.longhi@medtronic.com |
Contact: Talat Ashraf, MD | 408-548-6512 | talat.ashraf@medtronic.com |
United States, Arizona | |
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center | Recruiting |
Phoenix, Arizona, United States, 85013 | |
Contact: Volker Sonntag, MD | |
Contact: Jill Danielson, RN, MS |
Principal Investigator: | Volker Sonntag, MD | Barrow Neurological Institute, St. Joseph's Hospital and Medical Center |
Responsible Party: | Medtronic Spine LLC ( Medtronic Spine LLC ) |
Study ID Numbers: | LSS0702 |
Study First Received: | November 12, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00558129 |
Health Authority: | United States: Institutional Review Board |
Lumbar Spinal Stenosis X-STOP® IPD Interspinous process decompression Neurogenic Intermittent Claudication |
Spinal Diseases Arterial Occlusive Diseases Signs and Symptoms Musculoskeletal Diseases Vascular Diseases |
Intermittent Claudication Constriction, Pathologic Arteriosclerosis Bone Diseases Spinal Stenosis |
Cardiovascular Diseases |