Prospective Comparative Study of Open and Minimally Invasive Surgical Techniques in the Treatment of Degenerative One-level Stenosis of Lumbar Spine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index (ODI)
研究概览
简要总结
The purpose of this study is to evaluate the clinical and radiological results of surgical treatment of one-level central stenosis of the lumbar spine using traditional open approach (PLIF) and a minimally invasive procedure (MIS TLIF). According to the hypothesis, we assume that unilateral approach of MIS TLIF allows for adequate bilateral decompression of one-level central stenosis of the lumbar spine. Using MIS TLIF it is possible to perform reliable fixation of a spine segment and the formation of a complete intervertebral bone fusion. The long-term clinical results of surgical treatment with minimally invasive technologies (MIS TLIF) and traditional open approach (PLIF) suspected to be comparable.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •syndrome of mono- or polyradicular compression of the nerve roots with / without a reflex pain syndromes, caused by stenosis of one lumbar spine segment;
- •intermittent claudication caused by stenosis of one lumbar spine segment;
- •one-level spine stenosis in combination with local segment instability or degenerative spondylolisthesis at the same spine segment, requiring fusion in only one lumbar segment
排除标准
- •bilateral foraminal lumbar spine stenosis;
- •lumbar spine stenosis more than one-level;
- •spondylolisthesis II degree and more;
- •sagittal imbalance;
- •fusion the same lumbar spine segment after surgery previously;
- •other diseases of the spine, including trauma, tumor and inflammatory diseases of the lumbar spine, etc.
结局指标
主要结局
Oswestry Disability Index (ODI)
时间窗: Day of hospital discharge (10-15 day after surgery)
Oswestry Disability Index - patient-reported physical and household activity. Minimum - 0 (the worst result, patient is not physically active). Maximum - 50 (the best result). Improvement of ODI post-operatively as compared to baseline
次要结局
- Bone fusion(12 months)
- MRI capacity spine canal(Day of hospital discharge (10-15 day after surgery))
- Surgery duration(Day of surgery)
- Oswestry Disability Index (ODI)(3, 6 and 12 months)
- VAS (back, leg)(Day of hospital discharge (10-15 day after surgery), 3, 6 and 12 months)
- Blood loss(Day of surgery)