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| Sponsor: | Paradigm Spine |
|---|---|
| Information provided by: | Paradigm Spine |
| ClinicalTrials.gov Identifier: | NCT00534235 |
Purpose
To evaluate the safety and effectiveness of the coflex device compared to the control.
| Condition | Intervention |
|---|---|
|
Lumbar Spinal Stenosis |
Device: coflex Procedure: fusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
| Official Title: | A Multicenter, Prospective, Randomized, Clinical Trial Comparing Stabilization With Coflex vs. Pedicle Screw Fixation and Fusion After Decompression for at Least Moderate Lumbar Spinal Stenosis |
| Estimated Enrollment: | 460 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: coflex
stabilization with coflex
|
Device: coflex
stabilization with coflex
|
|
Active Comparator: fusion
pedicle screw fixation and fusion after decompression
|
Procedure: fusion
pedicle screw fixation and posterolateral fusion after decompression
|
The objective of this clinical trial is to evaluate the safety and effectiveness of the coflex device compared to a surgical control, posterolateral fusion with autograft bone and pedicle screw fixation, following decompressive laminectomy for the treatment of one or two level lumbar stenosis from L1-L5 that requires surgical decompression, and in patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 1 epidural steroid injection and at least 6 months of conservative treatment.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: coflex Spine Study | coflexstudy@paradigmspine.com |
| United States, Arizona | |
| Recruiting | |
| Phoenix, Arizona, United States | |
| United States, California | |
| Recruiting | |
| Colton, California, United States | |
| Recruiting | |
| Irvine, California, United States | |
| Recruiting | |
| Los Angeles, California, United States | |
| Recruiting | |
| Rancho Mirage, California, United States | |
| Recruiting | |
| San Diego, California, United States | |
| United States, Colorado | |
| Recruiting | |
| Loveland, Colorado, United States | |
| United States, Florida | |
| Recruiting | |
| Sarasota, Florida, United States | |
| Recruiting | |
| Tampa, Florida, United States | |
| United States, Maryland | |
| Recruiting | |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Recruiting | |
| Newton, Massachusetts, United States | |
| United States, Michigan | |
| Recruiting | |
| Royal Oak, Michigan, United States | |
| United States, Nevada | |
| Recruiting | |
| Las Vegas, Nevada, United States | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States | |
| United States, Oregon | |
| Recruiting | |
| Bend, Oregon, United States | |
| United States, Texas | |
| Recruiting | |
| Austin, Texas, United States | |
| Recruiting | |
| Dallas, Texas, United States | |
| Recruiting | |
| San Antonio, Texas, United States | |
| Recruiting | |
| Sherman, Texas, United States | |
| Recruiting | |
| Tyler, Texas, United States | |
| Study Director: | Paradigm Spine | Paradigm Spine |
More Information
| ClinicalTrials.gov Identifier: | NCT00534235 History of Changes |
| Other Study ID Numbers: | PS-001 |
| Study First Received: | September 20, 2007 |
| Last Updated: | June 2, 2009 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
back pain lumbar stenosis spine spinal back pain low back pain lumbar pain spinal stenosis lumbar stenosis |
lumbar spinal stenosis canal stenosis spinal canal stenosis lumbar canal stenosis central canal stenosis spinal canal pinched nerve pinched nerves pinched nerve root pinched nerve roots |
|
Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |