NCT02350621Unknown不适用
Cervical Foraminal Stenosis and Radiculopathy - Anterior Cervical Discectomy and Fusion (ACDF) Versus Minimal Invasive Posterior Cervical Foraminotomy miPCF).
Stockholm Spine Center AB0 个研究点目标入组 80 人开始时间: 2015年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Neck Disability Index
研究概览
简要总结
A prospective randomized clinical trial. Cervical spondylotic foraminal stenosis with radiculopahty. Comparison results between 2 treatment options: ACDF and minimal invasive posterior cervical foraminiotomy.
80 patients to be followed for 2 years. Parameters to study: NDI, VAS, EQ-5D, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cervical radiculopathy on 1 or 2 levels correlated on MRI and CT Arm pain more than 30 (VAS). Duration more than 3 months.
排除标准
- •Myelopathy. Soft disc hernia. Previous neck surgery. Tumors, infection, WAD, trauma, generalized pain syndrome.
研究组 & 干预措施
ACDF
Active Comparator
Anterior Cervical Discectomy and Fusion
干预措施: ACDF (Procedure)
miPCF
Active Comparator
minimal invasive Posterior Cervical Foraminotomy
干预措施: minimal invasive Posterior Cervical Foraminotomy (Procedure)
结局指标
主要结局
Neck Disability Index
时间窗: 24 months
次要结局
未报告次要终点
研究者
Andreas Selander
MD
Stockholm Spine Center AB
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