NCT01609712Unknown不适用
Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
University Hospital, Bonn1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume.
Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture.
In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 50 years
- •VAS over 49, ODI over 29
- •radiographic evidence of A 1.1, 1.2, 1.3 fractures
- •patients mentally capable to sign informed consent
排除标准
- •high-energy trauma
- •known tumor involvement
- •osteonecrotic fractures
- •burst fractures or pedicle fractures
- •previous surgical treatment for a vertebral body compression fracture
- •patient has paget's disease
- •BMI > 35
- •uncontrolled diabetes HbAc1c > 7%
- •severe cardiopulmonary disease
- •Myelopathy
- •long-time steroid therapy
研究者
Robert Pflugmacher
PD Dr. med.
University Hospital, Bonn
研究点 (1)
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