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【ChiCTR2000032800】Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

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基本信息

登记号

ChiCTR2000032800

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-05-11

临床申请受理号

靶点

适应症

Pilon骨折

试验通俗题目

Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

试验专业题目

Randomized Controlled Trial Comparing Open Reduction versus Ilizarov in the Management of AO Type C Pilon Fractures

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

75510

联系人通讯地址

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临床试验信息

试验目的

the aim of the study is to investigate the clinical effectiveness of ORIF versus Ilizarov for the management of Type C closed pilon fractures of the distal tibia

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

The patients were randomly allocated to either internal fixation or external fixation by a computer-generated sequence on a non-probability consecutive basis stratified by age and fracture type. Simple randomization was used in this study and delivered by a dedicated research officer to ensure that the allocation

盲法

Open label

试验项目经费来源

无

试验范围

目标入组人数

143;141

实际入组人数

第一例入组时间

2015-05-29

试验终止时间

2019-11-27

是否属于一致性

入选标准

The study included patients 18 years and older diagnosed with closed unilateral intraarticular pilon fracture of the distal tibia classified according to AO: AO 43 – C1, C2 and C3 (complete articular). Only unilateral fractures were included since problems may occur in rehabilitation with bilateral fractures which may compromise outcomes；

排除标准

The patients were excluded if they had a prior failed fixation; ipsilateral or contralateral lower limb fractures, dislocations, or both, pathological fracture; metabolic bone disease; or if the patient is/would be unable to understand instructions for treatment or was suffering from a mental illness, injury more than 21 days since injury, pre-existing (pre-injury) skin condition which precludes to open reduction and internal fixation or if the patient had multisystem injuries (polytrauma).；

研究者信息

研究负责人姓名

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试验机构

Jinnah Postgraduate Medical Centre, Karachi, Pakistan

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

75510

联系人通讯地址