Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 主要终点
- Radiological evaluation
研究概览
简要总结
Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 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
Radiological evaluation
时间窗: 12 months
Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray
次要结局
- Visual Analogue Scale(12 months)
研究者
Mohammad ARAB MOTLAGH
MD PhD
Johann Wolfgang Goethe University Hospital