NOC2 Spine Registry
- Conditions
- Spinal Disease
- Registration Number
- NCT02187666
- Lead Sponsor
- DC2 Healthcare
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- Patients undergoing lumbar or cervical surgery
- Understand and sign informed consent
- There are no specific exclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
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 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 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 4 weeks baseline and 4 weeks after surgery Pain intensity scale taken at baseline and 4 weeks after surgery
- Secondary Outcome Measures
Name Time Method 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.
Revision surgery within 30 days 30 days after surgery Length of hospital stay one to three days following surgery Date of discharge will be recorded, an average of one to three days
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 Assesses impact of disability in terms of activities of daily living. To be taken at baseline and 6 months after surgery.
Return to work 24 months after surgery Time off of work and whether patient returned restricted or unrestricted
Return to normal/usual activity 24 months after surgery Time between surgery and resuming normal activity for patient
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 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.
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.
Trial Locations
- Locations (1)
DC2 Healthcare
🇺🇸Nashville, Tennessee, United States