Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pseudoclaudication in one or both legs and backpain (VAS>30)
- •MRI with 1-2 adjacent stenotic segments (area <0.75 mm2)between L2 and sacrum
- •Duration of symptoms >6 months
- •Informed consent
排除标准
- •Spondylolysis
- •Degenerative lumbar scoliosis (Cobb angle >20 deg)
- •History of lumbar spinal surgery for spinal stenosis or instability
- •Stenosis not caused by degenerative changes
- •Stenosis caused by herniated disc
- •Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders
- •History of vertebral compression fractures in affected segments
- •Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: 2 years
A difference in ODI of 12 at follow up between the two interventions is considered as significant.
次要结局
- EuroQol (EQ-5D)(2 years)
- Back pain(2 years)
- Leg pain(2 years)
- Swiss Spinal Stenosis Questionnaire(2 years)