NCT05163795已完成不适用
Prediction of Fracture Nonunion Leading to Secondary Surgery in Patients With Distal Femur Fractures - Statistical Analysis Plan
Töölö Hospital1 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2019年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Reoperation
研究概览
简要总结
Here the investigators describe the statistical analysis plan for the study assessing the prediction of fracture nonunion leading to secondary surgery in patients with distal femur fractures.
详细描述
See attached PDF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years
- •AO/OTA type A or C distal femur fracture
- •Fracture located on the metaphyseal area of the distal femur (square method)
- •Operative treatment in the Helsinki University Hospital with a distal femur anatomic lateral locking plate
- •Operative treatment within 1 month after trauma
- •Operative treatment between years 2009 and 2018
排除标准
- •Stress fracture
- •Pathological fracture
- •An epicondylar or subchondral fracture
- •A ligament sprain in distal femur
- •Treatment with a double-plating method or with both plate and nail
- •Non-surgical treatment and patients who died before the treatment
- •Treatment with an unconventional plate (other than distal femur plate)
- •Patients whose follow-up criteria not fulfilled
结局指标
主要结局
Reoperation
时间窗: Within 36 months after the initial trauma
Reoperation due to fracture nonunion
次要结局
未报告次要终点
研究者
Heini Sainio
Principal Investigator, Resident in Orthopedics and Traumatology
Töölö Hospital
研究点 (1)
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