National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Disease
- Sponsor
- DC2 Healthcare
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Change in Visual Analogue Scale (VAS) from baseline at 24 months
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing lumbar or cervical surgery
- •Understand and sign informed consent
Exclusion Criteria
- •There are no specific exclusion criteria
Outcomes
Primary Outcomes
Change in Visual Analogue Scale (VAS) from baseline at 24 months
Time Frame: baseline and 24 months after surgery
Pain intensity scale taken at baseline and 24 months after surgery
Change in Visual Analogue Scale (VAS) from baseline at 6 months
Time Frame: 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 3 months
Time Frame: 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 12 months
Time Frame: 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 4 weeks
Time Frame: baseline and 4 weeks after surgery
Pain intensity scale taken at baseline and 4 weeks after surgery
Secondary Outcomes
- Change from baseline in Oswestry Disability index at 4 weeks(baseline and 4 weeks after surgery)
- Revision surgery within 30 days(30 days after surgery)
- Length of hospital stay(one to three days following surgery)
- Fusion at 6 months(6 months post-op)
- Complications(24 months after surgery)
- Change from baseline in Oswestry Disability index at 6 months(baseline and 6 months after surgery)
- Return to work(24 months after surgery)
- Return to normal/usual activity(24 months after surgery)
- Change from baseline in Oswestry Disability index at 24 months(baseline and 24 months after surgery)
- Change from baseline in Oswestry Disability index at 3 months(baseline and 3 months after surgery)
- Change from baseline in Oswestry Disability index at 12 months(baseline and 12 months after surgery)