NOC2 Spine Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products

Conditions
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Spinal Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing lumbar or cervical surgery Understand and sign informed consent Exclusion Criteria: There are no specific exclusion criteria
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lumbar<br>Patients undergoing lumbar spinal surgery | |
| Cervical<br>Patients undergoing cervical spine surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar, Cervical, Spine, Spinal Disease