NCT00546949终止不适用
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Claudication
研究概览
简要总结
The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neurogenic intermittent claudication due to lumbar spinal stenosis
- •diagnosed on MRI in maximum two levels
- •walking distance on 250 metres
- •symptom relief on flexion of the lumbar spine
- •duration of the symptoms more than 6 months
- •non-operative treatment is tried or considered as not indicated
排除标准
- •vascular claudicatio intermittens
- •spinal stenosis on more than 2 levels
- •cauda equina syndrome
- •severe paresis
- •clinical monoradiculopathy
- •grave scoliosis
- •previous lumbar surgery
- •degenerative spondylolisthesis more than 25%
- •spondylolysis with listhesis
- •osteoporotic fracture in lumbal column
- •clinical and radiological (both) arthritis in the hip joint
- •verified polyneuropathy on neurophysiological test
研究组 & 干预措施
decompression
Active Comparator
Minimal invasive decompression
干预措施: Minimal invasive decompression (Procedure)
x-stop
Experimental
X-stop, an interspinous decompression device
干预措施: Interspinous Process Decompression (IPD) (Procedure)
结局指标
主要结局
Claudication
时间窗: 2 years
Zürich Claudication Questionnaire
次要结局
- self-evaluated health condition(2 years)
研究者
研究点 (1)
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