National Neurosurgical and Orthopedic Optimum Care Continuum Spine Registry Exposure for Various Implants/Products
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Scale (VAS) from baseline at 24 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lumbar or cervical surgery
- •Understand and sign informed consent
排除标准
- •There are no specific exclusion criteria
结局指标
主要结局
Change in Visual Analogue Scale (VAS) from baseline at 24 months
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: baseline and 4 weeks after surgery
Pain intensity scale taken at baseline and 4 weeks after surgery
次要结局
- 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)