跳至主要内容
临床试验/NCT01085669
NCT01085669Unknown不适用

Infection Rate of VEPTR-Implants in Children With Severe Spinal and Thoracic Deformities

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年9月最近更新:
适应症

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

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

研究者

申办方类型
Other

研究点 (1)

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