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临床试验/NCT03364595
NCT03364595Unknown不适用

Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

Peking University People's Hospital0 个研究点目标入组 60 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
Union rate

研究概览

简要总结

To compare the effect of Operative Plate Fixation Versus Replacement for Mason Type III Fracture of Radial Head

详细描述

From April 2015 to October 2016, patients with comminuted radial head fractures diagnosed as Mason type III are retrospectively included in this study, they were treated with either operative plate or radial head replacement. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(Mayo score) between the 2 groups at 1 year after surgery.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women aged 18 to 65 years of age with Mason Type III radial head fracture are confirmed by radiograph within 1 month post injury Provision of informed consent

排除标准

  • Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

结局指标

主要结局

Union rate

时间窗: 1 year after surgery

Union rate of the fracture from X-ray

次要结局

  • Functional score(1 year after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Yichong

Department of orthopaedics and trauma

Peking University People's Hospital

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