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临床试验/NCT02977910
NCT02977910Unknown不适用

Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture

Liming Cheng0 个研究点目标入组 200 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
AOFAS score

研究概览

简要总结

Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.

详细描述

Comparative study for ankle fracture combined with deltoid ligament rupture: with & without repair of ligament

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, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • ankle fracture with deltoid ligament rupture

排除标准

  • ankle fracture without deltoid ligament rupture

结局指标

主要结局

AOFAS score

时间窗: 12 months after surgery

次要结局

未报告次要终点

研究者

发起方
Liming Cheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Liming Cheng

Director, Head of orthopedics, Pricipal investigator, Clinical professor

Shanghai Tongji Hospital, Tongji University School of Medicine

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