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临床试验/NCT02557113
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

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

发起方
Mohammad ARAB MOTLAGH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohammad ARAB MOTLAGH

Dr. med.

Johann Wolfgang Goethe University Hospital

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