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| Name | Class |
|---|---|
| SPIRITT Research | UNKNOWN |
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The purpose of the coflexCOMMUNITY observational study is to collect information on patients with spinal stenosis undergoing back surgery with the coflex® implant, and to look at their outcomes and the cost-effectiveness of this procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stenosis patients treated with coflex | Patients with a primary diagnosis of lumbar spinal stenosis treated with coflex after decompression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coflex | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the Oswestry Disability Index (ODI), compared to pre-surgery | The primary variable of performance is the assessment of Oswestry Low Back Pain Disability Index (ODI). It will be assessed if the improvement in ODI since the pre-surgery status is at least 15 points | 5 years |
| Patient has not undergone any reoperations, removals, revisions, or supplemental fixations; | Assessment of reoperations, revisions, removals, or supplemental fixation associated with the coflex device. | 5 years |
| Patient has not had any major device related complications | Assessment of major device-related complications, including but not limited to permanent new or increasing sensory or motor deficit at 2 years and 5 years. | 5 years |
| Patient has not undergone any Epidural injections | Assessment of lumbar epidural injections | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Zurich Claudication Questionnaire (ZCQ) | ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis. | 5 years |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort will be selected from clinic patients scheduled for surgery with coflex device after decompression
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neurology and Spine | Phoenix | Arizona | 85032 | United States | ||
| Arizona Brain and Spine |
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Assessment of the patient's Quality of Life as measured by the Health Outcomes Survey and EQ-5D-5L
| 5 years |
| VAS Leg Pain | Change in the assessment of leg pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale). | 5 years |
| VAS Back Pain | Change in the assessment of back pain compared to pre-surgery as measured by a Visual Analog Scale (VAS) (on the 100mm scale). | 5 years |
| Scottsdale |
| Arizona |
| 85225 |
| United States |
| Northwest NeuroSpecialists | Tucson | Arizona | 85741 | United States |
| The Spine Institute, Center for Spine Restoration | Santa Monica | California | 90403 | United States |
| Cantor Spine institute | Fort Lauderdale | Florida | 33306 | United States |
| Southeastern Integrated Medical | Gainesville | Florida | 32607 | United States |
| The Orthopaedic Institute | Gainesville | Florida | 32607 | United States |
| The BACK Center | Melbourne | Florida | 32901 | United States |
| All Florida Orthopaedics | St. Petersburg | Florida | 33703 | United States |
| Laser Spine Institute | Tampa | Florida | 33607 | United States |
| OrthoAtlanta | Lawrenceville | Georgia | 30046 | United States |
| Orthospine Center LTD | Palos Heights | Illinois | 60463 | United States |
| Orthopedic Center of Illinois | Springfield | Illinois | 62711 | United States |
| Brigham and Women's | Boston | Massachusetts | 02115 | United States |
| New England Orthopedic Surgeons | Springfield | Massachusetts | 01107 | United States |
| The Orthopedic Center of St. Louis | St Louis | Missouri | 63017 | United States |
| Orthopedic Sports Medicine & Spine Care Institute | St Louis | Missouri | 63122 | United States |
| North Jersey Brain and Spine Center | Oradell | New Jersey | 07649 | United States |
| IGEA Brain and Spine | Union | New Jersey | 07083 | United States |
| Spine and Orhtopedic Center of New Mexico | Roswell | New Mexico | 88201 | United States |
| Bassett Medical Center | Cooperstown | New York | 13326 | United States |
| Blue Ridge Bone and Joint | Arden | North Carolina | 28704 | United States |
| OrthoNeuro | Dublin | Ohio | 43017 | United States |
| Consulting Orthopaedic Associates | Sylvania | Ohio | 43560 | United States |
| OrthoTexas | Carrollton | Texas | 75010 | United States |
| Center for Spine Care | Dallas | Texas | 75287 | United States |
| NeoSpine | Seattle | Washington | 98372 | United States |
| Bighorn Medical Center | Cody | Wyoming | 82414 | United States |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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