Effect of rhBMP-2 or rhBMP-7 on Long Bone Fractures and Non-unions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Time to Union
研究概览
简要总结
Delayed fracture healing continues to cause significant patient morbidity and economic burden to society. Biological stimulation of acute fractures and non-unions includes application of rhBMP-2 and rhBMP-7. However, BMP use continues to be a matter of controversy as literature shows scarce evidence for treatment effectiveness. The aim of this study is to compare acute fractures and non-unions in the long bones humerus, femur and tibia with and without BMP treatment of acute fractures. Furthermore, the investigators want to identify complications and risk factors on union-rate and time to union.
详细描述
Primary Objective:
The primary objective is to assess time to union and union rate after rhBMP-2 and rhBMP-7 application at long bone fractures and non-unions.
Secondary Objective(s):
- Analysis of secondary complications
- Analysis of risk factors
Hypothesis and Statistical considerations and estimated enrollment:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long bone fracture or long bone non-union.
- •Signed informed consent, if required by IRB/EC
排除标准
- •Prisoner at date of inclusion
结局指标
主要结局
Time to Union
时间窗: 24 months
Time to Union in months
Union-rate
时间窗: 24 months
Union-rate in percentage
次要结局
- complications/Adverse Events related to implant or surgery(24 months)
- Risk factor analysis(24 months)