Spine Registry Exposure for: Lumbar and Cervical Surgery Utilizing IOM
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 from baseline in Neurological Assessment at 6 weeks
研究概览
简要总结
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the optimal management of the surgical patient.
详细描述
Prospective reports will be collected on approximately 10,000 patients undergoing lumbar or cervical spinal surgery using intraoperative monitoring. Patients will be enrolled in registry after signing informed consent. Data will be collected prior to surgery, during surgery, immediately following surgery and 4 to 6 weeks post surgery. The registry will serve as a database for surgeries using IOM.
Specific outcome measures will be: neurological assessment, length of hospital stay, pain intensity, and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lumbar or cervical surgery
- •Utilization of IOM
- •Understand and sign informed consent
排除标准
- •There are no specific exclusion criteria
结局指标
主要结局
Change from baseline in Neurological Assessment at 6 weeks
时间窗: baseline and 6 weeks
Motor, Reflex, and Sensory testing will be assessed for change from baseline, within 6 weeks but not less than 4 weeks
Change in Pain Intensity from Baseline at 24 hours
时间窗: baseline and 24 hours from time of surgery
Pain intensity will be measured by Visual Analogue Scale (VAS) for change from baseline and 24 hours after surgery
Change from baseline in Neurological Assessment at 24 hours
时间窗: baseline and 24 hours from time of surgery
Motor, Reflex, and Sensory testing will be assessed for change from baseline and 24 hours after surgery
Complications
时间窗: 6 weeks after surgery
within 6 weeks after surgery but not less than 4 weeks
Change in Pain Intensity from Baseline at 6 weeks
时间窗: baseline and 6 weeks
Pain intensity will be measured by Visual Analogue Scale (VAS) within 6 weeks but not less than 4 weeks
次要结局
未报告次要终点