Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Infection rate of VEPTR Implants
研究概览
简要总结
The study is conducted to analyse the infection rate in children treated with VEPTR-Implants for severe spine or thoracic deformities.
详细描述
Spinal and thoracic deformities in children can be treated with vertical expandable prosthetic titanium ribs (VEPTR©, Synthes GmbH®) to stimulate thoracic and spinal growth. With these implants children's symptoms and conditions can be slowed, halted or even reversed. Because of the dynamic character of the deformity and the growth of the children, the implants have to be lengthened about every half a year. With each operation there is a small risk of infection, which might increase with number of previous surgeries. Implant associated infections are often not clinical apparent and only found in microbiological analysis. To objectify the infection rate, identify potential precursors of infections and the relevance of asymptomatic infections in children with these implants a prospective study is conducted.
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
- 1 Year 至 30 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients admitted at the University Children's Hospital Basel in whom a VEPTR©-implant or parts of it will be removed.
排除标准
- •obvious contamination of an explanted component occurred in the operating room.
结局指标
主要结局
Infection rate of VEPTR Implants
时间窗: two years
次要结局
未报告次要终点
