NCT01574833已完成4 期
Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- percentage of patient achieving fracture union
研究概览
简要总结
The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture.
排除标准
- •Implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing
结局指标
主要结局
percentage of patient achieving fracture union
时间窗: 12 months
次要结局
- pain(12 months)
研究者
Jin XIONG
Professor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究点 (1)
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