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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 | Other | VIA Disc NP - Allograft tissue injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) | 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 months |
| Oswestry Disability Index (ODI) | 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 months |
| Patient Satisfaction | Patient reported assessment of treatment regarding their experience with the procedure. Four different responses, which range from Not at all satisfied (worst) to Extremely Satisfied (best). | 1, 3, 6, & 12 months |
| Frequency of Pain Medication Use | Assesses the frequency and type of pain medication administered to participants at baseline and follow-up visits scheduled at 1, 3, 6, and 12 months. Data will be collected to track changes in pain medication usage over time. | 1, 3, 6, & 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants diagnosed with and treated for back pain.
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Zaccari | Sponsor - Vivex Biologics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mocek Spine | Little Rock | Arkansas | 72205 | United States | ||
| MD Pain |
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| Englewood |
| Colorado |
| 80112 |
| United States |
| Western Rockies Interventional Pain | Grand Junction | Colorado | 81505 | United States |
| Premier Spine and Pain Institute | Thornton | Colorado | 80229 | United States |
| The Orthopedic Institute | Gainesville | Florida | 32605 | United States |
| Raso Pain Center | Jupiter | Florida | 33477 | United States |
| Interventional Spine Care of the Palm Beaches | West Palm Beach | Florida | 33407 | United States |
| Horizon Clinical Research | Jasper | Georgia | 30143 | United States |
| The Orthopedic Research Foundation, Inc. | Fishers | Indiana | 46278 | United States |
| Interventional Pain Specialists - Pain Clinic | Opelousas | Louisiana | 70570 | United States |
| Paradigm Health System | Slidell | Louisiana | 70461 | United States |
| Premier Pain Solutions | Asheville | North Carolina | 28803 | United States |
| Comprehensive Pain Consultants of the Carolinas | Hendersonville | North Carolina | 28791 | United States |
| Crystal Coast Pain Management | Morehead City | North Carolina | 28557 | United States |
| Crystal Coast Pain Management | New Bern | North Carolina | 28560 | United States |
| Align Interventional Pain | Edmond | Oklahoma | 73013 | United States |
| Atlantic Coast Spine & Pain | Conway | South Carolina | 29526 | United States |
| Renew Pain Solutions | Greenville | South Carolina | 29607 | United States |
| Specialists in Pain Managment | Chattanooga | Tennessee | 37404 | United States |
| Freedom Spine | Boerne | Texas | 78006 | United States |
| Corpus Chrisi Pain Medicine | Corpus Christi | Texas | 78415 | United States |
| Advanced Spine and Pain Center | San Antonio | Texas | 78240 | United States |
| Pain and Wellness Institute of Texas | Spring Branch | Texas | 80700 | United States |
| Precision Spine Care | Tyler | Texas | 75701 | 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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