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| Name | Class |
|---|---|
| National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2) | UNKNOWN |
| National Research Independent Operations Management | OTHER |
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The primary objective of the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.
This study will enhance the understanding of the variability, progression and treatment of spinal disease with the ultimate goal of better guiding and assessing therapeutic intervention. Researchers will collect complications and safety following cervical and lumbar surgeries to determine best options for patients. Prospective reports will be collected on patients undergoing lumbar or cervical spinal surgery. Patients will be enrolled in registry after signing informed consent. Data will be collected at various time points. The registry will serve as a database of cervical and lumbar surgeries in which retrospective analysis and exploratory analysis of specific research questions can be answered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar | Patients undergoing lumbar spinal surgery | ||
| Cervical | Patients undergoing cervical spine surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale (VAS) from baseline at 4 weeks | Pain intensity scale taken at baseline and 4 weeks after surgery | baseline and 4 weeks after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 3 months | Pain intensity scale taken at baseline and 3 months after surgery | baseline and 3 months after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 6 months | Pain intensity scale taken at baseline and 6 months after surgery | baseline and 6 months after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 12 months | Pain intensity scale taken at baseline and 12 months after surgery | baseline and 12 months after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 24 months | Pain intensity scale taken at baseline and 24 months after surgery | baseline and 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Oswestry Disability index at 4 weeks | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery. | baseline and 4 weeks after surgery |
| Fusion at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 10,000 patients undergoing lumbar or cervical surgery will be screened to decide whether they meet the inclusion and exclusion criteria of the study/patient registry. Patients who meet the study criteria will be informed by the investigator and should read the 'patient information' document. Patients must give their written informed consent to be enrolled into this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina R Cook, PhD | Contact | 615-712-9574 | ccook@dc2healthcare.com | |
| Risa Tyo, PharmD | Contact | 615-712-9574 | rtyo@dc2healthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DC2 Healthcare | Recruiting | Nashville | Tennessee | 37211 | United States |
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| Label | URL |
|---|---|
| DC2 Healthcare | View source |
| NRIOM | View source |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 6 months post-op |
| Length of hospital stay | Date of discharge will be recorded, an average of one to three days | one to three days following surgery |
| Revision surgery within 30 days | 30 days after surgery |
| Return to work | Time off of work and whether patient returned restricted or unrestricted | 4 weeks after surgery |
| Return to normal/usual activity | Time between surgery and resuming normal activity for patient | 4 weeks after surgery |
| Complications | 24 hours after surgery |
| Change from baseline in Oswestry Disability index at 3 months | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery. | baseline and 3 months after surgery |
| Change from baseline in Oswestry Disability index at 6 months | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery. | baseline and 6 months after surgery |
| Change from baseline in Oswestry Disability index at 12 months | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery. | baseline and 12 months after surgery |
| Change from baseline in Oswestry Disability index at 24 months | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery. | baseline and 24 months after surgery |
| Return to work | Time off of work and whether patient returned restricted or unrestricted | 3 months after surgery |
| Return to work | Time off of work and whether patient returned restricted or unrestricted | 6 months after surgery |
| Return to work | Time off of work and whether patient returned restricted or unrestricted | 12 months after surgery |
| Return to work | Time off of work and whether patient returned restricted or unrestricted | 24 months after surgery |
| Return to normal/usual activity | Time between surgery and resuming normal activity for patient | 3 months after surgery |
| Return to normal/usual activity | Time between surgery and resuming normal activity for patient | 6 months after surgery |
| Return to normal/usual activity | Time between surgery and resuming normal activity for patient | 12 months after surgery |
| Return to normal/usual activity | Time between surgery and resuming normal activity for patient | 24 months after surgery |
| Complications | 4 weeks after surgery |
| Complications | 3 months after surgery |
| Complications | 6 months after surgery |
| Complications | 12 months after surgery |
| Complications | 24 months after surgery |