PMCF Study - Verification of Activa IM-Nail™ Safety and Clinical Performance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 17
- 主要终点
- Refracture rate
研究概览
简要总结
The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.
详细描述
Residual risk related to re-fracture rate will be addressed by this PMCF study. The research question is, if the re-fracture risk with Activa IM-nail is in line with the other treatment methods, namely ESIN.
Primary objective: will be to assess clinical outcome by determining re-fracture rate of all treated patients, difference of re-fracture rate depending on the fracture type determined by X-ray (e.g. greenstick vs. non-greenstick fracture), subject's age, BMI, surgical technique, immobilization time and bony union formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diaphyseal forearm fractures (radius or ulna or both)
- •Patients from 3 years to under 13 years, but the age limits depend on the biological development of the child and in addition
排除标准
- •multifragmentary fractures, metaphyseal and epiphyseal fractures
- •Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection, or where a patient's cooperation cannot be guaranteed.
结局指标
主要结局
Refracture rate
时间窗: First year after operation
Assessment of refracture rate
次要结局
- Absorption of implant(One and two years after operation)
- Bony union(One year after operation)
- Monteggia lesion and equivalent(2 years after operation)
- Cost effectiveness(1 year after operation)
研究者
Thomas Klestil
Univ.-Prof. DDr. Thomas Klestil
Danube University Krems