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Sponsor decision.
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Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIA Disc NP | Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIA Disc NP (HCT/P) | Other | VIA Disc NP - Allograft tissue injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reporting of daily function | Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain. | 1, 3, 6, 12, 24, & 36 months |
| Patient self-reported back pain | Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). | 1, 3, 6, 12, 24, & 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient self-reported mental health | Change in patient reported anxiety and depression scores. Four question scale used for patient self-reporting of anxiety and depression which ranges from 0-2 (normal), mild (3-5), moderate (6-8), and severe (9-12). | 1, 3, 6, 12, 24, & 36 months |
| Resource Utilization |
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Inclusion Criteria:
Exclusion Criteria:
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Registry will include at least 10,000 patients diagnosed with and treated for back pain across approximately 200 selected sites.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Finstein, MHA | Vivex Biologics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gateway Pain Solutions | Mesa | Arizona | 85206 | United States | ||
| Source Healthcare |
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Patient reported assessment of healthcare and resources utilized questions to treat ongoing back pain post treatment. |
| 1, 3, 6, 12, 24, & 36 months |
| Santa Monica |
| California |
| 90403 |
| United States |
| Interventional Pain Management | Walnut Creek | California | 94598 | United States |
| MD Pain | Englewood | Colorado | 80112 | United States |
| Western Rockies Interventional Pain Specialists | Grand Junction | Colorado | 81505 | United States |
| The Denver Spine & Pain Institute | Greenwood Village | Colorado | 80111 | United States |
| International Spine, Pain & Performance Center | Washington D.C. | District of Columbia | 20006 | United States |
| The Orthopedic Institute | Gainesville | Florida | 32607 | United States |
| Southwest Florida Pain Center | Port Charlotte | Florida | 33948 | United States |
| FAST MD | Tampa | Florida | 33609 | United States |
| Florida Spine & Pain Specialists | Tampa | Florida | 33614 | United States |
| Florida Pain Medicine | Wesley Chapel | Florida | 33544 | United States |
| Orthopaedic Research Foundation | Indianapolis | Indiana | 46278 | United States |
| Anesthesiology & Pain Consultants | Lafayette | Louisiana | 70508 | United States |
| Interventional Pain Specialists | Opelousas | Louisiana | 70570 | United States |
| Michigan Interventional Pain Center | Brownstown | Michigan | 48183 | United States |
| Forest Health | Ypsilanti | Michigan | 48198 | United States |
| Nevada Advanced Pain Specialists | Reno | Nevada | 89511 | United States |
| Ainsworth Institute of Pain Management | New York | New York | 10022 | United States |
| Premier Pain Solutions | Asheville | North Carolina | 28803 | United States |
| Crystal Coast Pain Management | New Bern | North Carolina | 28560 | United States |
| Premier Pain | Loveland | Ohio | 45140 | United States |
| Invictus Healthcare System | Tulsa | Oklahoma | 74133 | United States |
| Center for Interventional Pain Spine | Chadds Ford | Pennsylvania | 19317 | United States |
| Atlantic Coast Pain Management | Conway | South Carolina | 29526 | United States |
| Southeastern Spine Institute | Mt. Pleasant | South Carolina | 29464 | United States |
| Specialist in Pain Management | Chattanooga | Tennessee | 37404 | United States |
| Vertex Spine | Franklin | Tennessee | 37067 | United States |
| Ortho Spine Surgery Institute | North Richland Hills | Texas | 76182 | United States |
| MD SpineCare and DC Medical Solutions | San Antonio | Texas | 78229 | United States |
| Advanced Spine and Pain Center | San Antonio | Texas | 78258 | United States |
| The Sprintz Center for Pain | Shenandoah | Texas | 77384 | United States |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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