Clinical Study of Bilateral Decompression With Interbody Fusion for Spondylolisthesis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- visual analog scale for low back pain and leg pain
研究概览
简要总结
Laminectomy with PLIF has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft-tissue structures. The investigators plan to compare the clinical and radiographic outcomes of bilateral decompression with transforaminal lumbar interbody fusion and laminectomy with posterior lumbar interbody fusion in the treatment of degenerative spondylolisthesis.
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
- Single (Outcomes Assessor)
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
- •lumbar spondylolisthesis
- •symptoms of low back pain and/or neurogenic claudication with or without radiculopathy referable to the lumbar spine,
- •at least 3 months of failed conservative therapies
排除标准
- •multilevel lumbar degenerative diseases
- •history of previous lumbar surgery
结局指标
主要结局
visual analog scale for low back pain and leg pain
时间窗: 2 years postoperatively
Oswestry disability index
时间窗: 2 years postoperatively
Zurich claudication questionnaire
时间窗: 2 years postoperatively
SF-36 score
时间窗: 2 years postoperatively
Fusion rate
时间窗: 2 years postoperatively
次要结局
- Surgery procedure duration(Intraoperation)
- Estimated blood loss(Intraoperation)
- Length of postoperative hospital stay(1 week after hospital discharge)
- Complication(2 years postoperatively)
- Disc space height measured by X ray(2 years postoperatively)
- Lumbar lordosis measured by X ray(2 years postoperatively)
- Degree of spondylolisthesis measured by X ray(2 years postoperatively)
研究者
Xiaofei Cheng
M.D.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University