NCT03937310Unknown不适用
What is the Role of Next-generation Sequencing in Non-union of Orthopaedic Cases
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Treatment failure
研究概览
简要总结
The purpose of this study is to investigate the role of genetic testing to look for possible infection as a cause for failure of non-healing fractures. The study aims to compare the results of genetic testing known as NGS to standardized clinical laboratory tests for diagnosing infections to see if NGS may be a better diagnostic tool.
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
- •Nonunions will be defined as a failure to progress towards expected union within an anticipated timeframe, and this judgment will be made by the attending caring for each patient. No specific timeframe or arbitrary cut points will be defined to allow for the considerable variation in fracture healing and different anatomical sites.
- •Presumed Septic and Aseptic nonunions
- •>18 years old and able to provide informed consent
排除标准
- •Pathological fractures at index injury
- •Patients on antibiotic therapy <2 weeks prior to surgery
- •INCLUSION/ EXCLUSION CRITERIA FOR CONTROL GROUP:
- •Patients undergoing surgical intervention for nonunion following a traumatic closed long bone fractures (femur shaft, tibia, humerus)
- •>18 years old and able to provide informed consent
- •Pathological fractures at index injury
- •Patients on antibiotic therapy <2 weeks prior to surgery
结局指标
主要结局
Treatment failure
时间窗: 6 months post-op
Need for additional re-operation or intervention within follow-up period
次要结局
未报告次要终点
研究者
研究点 (1)
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