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临床试验/NCT03358784
NCT03358784Unknown不适用

A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.

Peking University People's Hospital0 个研究点目标入组 300 人开始时间: 2018年3月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
Postoperative complications

研究概览

简要总结

To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus

详细描述

From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • three or four part fractures of proximal humerus

排除标准

  • Severe comminuted fractures of proximal humerus
  • past history of injured-side shoulder surgery
  • Patients who cannot tolerate surgery

结局指标

主要结局

Postoperative complications

时间窗: 6 months after surgery

Postoperative complications were observed

次要结局

  • EQ-5D(6 months after surgery)
  • ASES score(6 months after surgery)

研究者

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

Zhang Peixun

Department of orthopaedics and trauma

Peking University People's Hospital

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