Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in microcirculation (composite outcome measure)
研究概览
简要总结
In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human in-vivo setting for the first time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid.
- •Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
- •Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid.
- •Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.
排除标准
- •below 18 years of age
- •scar tissue above scaphoid or metacarpal bone
- •osteoporosis or comparable bone disease
- •medication that influences bones
结局指标
主要结局
Change in microcirculation (composite outcome measure)
时间窗: Baseline and 1 minute post-dose
* Bone blood flow \[arbitrary units AU\] * Bone blood velocity \[AU\] * Tissue oxygen saturation \[%\] * Relative postcapillary venous filling pressure \[AU\] (Composite outcome measure)
次要结局
未报告次要终点
研究者
Tobias Kisch
MD
University Hospital Schleswig-Holstein