Spinal Disease
Conditions
Keywords
Cervical, Lumbar, Spine, Spinal Disease
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Neurosurgical and Orthopedic Optimum Care Continuum (NOC2)
National Research Independent Operations Management
DC2 Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing lumbar or cervical surgery * Understand and sign informed consent
Exclusion criteria
* There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS) from baseline at 4 weeks | baseline and 4 weeks after surgery | Pain intensity scale taken at baseline and 4 weeks after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 3 months | baseline and 3 months after surgery | Pain intensity scale taken at baseline and 3 months after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 6 months | baseline and 6 months after surgery | Pain intensity scale taken at baseline and 6 months after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 12 months | baseline and 12 months after surgery | Pain intensity scale taken at baseline and 12 months after surgery |
| Change in Visual Analogue Scale (VAS) from baseline at 24 months | baseline and 24 months after surgery | Pain intensity scale taken at baseline and 24 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Revision surgery within 30 days | 30 days after surgery | — |
| Return to work | 4 weeks after surgery | Time off of work and whether patient returned restricted or unrestricted |
| Change from baseline in Oswestry Disability index at 3 months | baseline and 3 months after surgery | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 3 months after surgery. |
| Return to normal/usual activity | 4 weeks after surgery | Time between surgery and resuming normal activity for patient |
| Change from baseline in Oswestry Disability index at 12 months | baseline and 12 months after surgery | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 12 months after surgery. |
| Change from baseline in Oswestry Disability index at 24 months | baseline and 24 months after surgery | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 24 months after surgery. |
| Change from baseline in Oswestry Disability index at 6 months | baseline and 6 months after surgery | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery. |
| Complications | 24 hours after surgery | — |
| Change from baseline in Oswestry Disability index at 4 weeks | baseline and 4 weeks after surgery | Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 4 weeks after surgery. |
| Fusion at 6 months | 6 months post-op | — |
| Length of hospital stay | one to three days following surgery | Date of discharge will be recorded, an average of one to three days |
Countries
United States
Contacts
Primary ContactChristina R Cook, PhD
Backup ContactRisa Tyo, PharmD
Outcome results
None listed