NCT01220921已完成3 期
Neurosurgery Patient Outcomes in Treating Spinal Disorders
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 25
- 主要终点
- Site and Physician Compliance
研究概览
简要总结
The creation of a multi-center cooperative research group encompassing academic and community-based spinal practices . . .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade I degenerative or isthmic spondylolisthesis recalcitrant to non-invasive therapies for at least 3 months or Lumbar degenerative disc herniation with radiculopathy refractory to non-invasive therapies for at least 6 weeks
排除标准
- •History of previous lumbar spine surgery
- •Significant motor weakness (3/5) (i.e. foot drop)
- •Cancer, infection, or fracture
- •Pregnancy
结局指标
主要结局
Site and Physician Compliance
时间窗: 1 Year
Goal = 80% compliance in enrolling 20 patients over 1 year with completed outcomes instruments
SF-36 version 1
时间窗: 1-Year
Health-realted quality of life outcome measure
次要结局
- Oswestry Disability Index (ODI)(1 Year)
- Visual Analog Pain Score(1 Year)
- Return to Work(1 Year)
- 30 day complications(30 days)
- Delayed Surgical Complications(1 year)
研究者
研究点 (25)
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