NCT02557113已完成不适用
Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
Mohammad ARAB MOTLAGH0 个研究点目标入组 36 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- CT-Scan evaluation
研究概览
简要总结
Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification
排除标准
- •More Than 2 Vertebral Body Fractures
- •Fractures of Vertebral Body Based on Malignancy
- •Previous Spinal Operation
- •Spinal Infection
- •Spinal Deformity (scoliosis)
结局指标
主要结局
CT-Scan evaluation
时间窗: One week
Number of Cement Extravasation in each Vertebral Body
次要结局
- Visual Analogue Scale(3 Months)
研究者
Mohammad ARAB MOTLAGH
Dr. med.
Johann Wolfgang Goethe University Hospital
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