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临床试验/NCT00635297
NCT00635297暂停不适用

Percutaneous Vertebroplasty.Study of Refracture Rates After Prophylactic Vertebroplasty of Adjacent Vertebrae

Ullevaal University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
100
试验地点
2
主要终点
Refracture rate based on MRI and CT after 3 months and one year

研究概览

简要总结

Percutaneous vertebroplasty is a treatment for painful osteoporotic compression fractures. Multiple reports have shown as high as 20 % refracturerates in vertebrae adjacent to those that have been treated with percutaneous vertebroplasty.

The purpose of the study is to determine if prophylactic vertebroplasty of unfractured vertebrae adjacent to the treated fractured vertebrae can reduce the rates of refracture in adjacent vertebrae.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CT and MRI proven non healed painful osteoporotic compression fracture in the thoracic and lumbar spine.

排除标准

  • Infection
  • High grade spinal stenosis
  • Contraindications to MRI

结局指标

主要结局

Refracture rate based on MRI and CT after 3 months and one year

时间窗: 3 months and one year

次要结局

  • Pain relief after the procedure based on VAS(3 months and one year)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other

研究点 (2)

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