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【ChiCTR2000032843】To cast or not to cast distal radius fractures in the elderly

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基本信息

登记号

ChiCTR2000032843

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

2020-05-13

临床申请受理号

靶点

适应症

桡骨远端骨折

试验通俗题目

To cast or not to cast distal radius fractures in the elderly

试验专业题目

A Randomized Control Trial for Comparing the Patient Reported Outcomes in Distal radius Fractures managed by either cast immbolization or volar locking plate in the edlderl spinal anesthesia

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

75500

联系人通讯地址

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临床试验信息

试验目的

the authors aimed to performed a randomized control trial comparing casting with plating in the elderly population with the hypothesis that plating leads to a better patient satisfaction (SF-12 form), patient reported outcomes (PROMS) and clinical outcomes at 3 months, 6 months, 1-year and 2 year time period.

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期

随机化

computer-generated randomization

盲法

Open label

试验项目经费来源

Nil

试验范围

目标入组人数

549;547

实际入组人数

第一例入组时间

2015-02-18

试验终止时间

2020-04-20

是否属于一致性

入选标准

The study included patients that were 60 years and above of either gender Other parameters for the participants to be included in the trial were an isolated distal radius fracture (extra-articular or intra-articular) presented to the authors institute within seven days from the time of injury, stable fractures, unstable fractures which were defined as 1) an inadequate initial reduction i.e. not restoring the anatomical parameters or 2) an initial loss of reduction at one week (defined as more than 10° of dorsal angulation of the distal fracture fragment, 3 mm or more shortening of ulnar variance, articular step-off of more than 2 mm) 3) comminuted distal fragment.；

排除标准

Patients were excluded if they had a sustained an open fracture, bilateral fractures of the distal radius, and ipsilateral limb fractures/injuries, multiple injuries or polytrauma, if they presented more than two weeks after the injury, if the fracture extended more than 3 cm from the radiocarpal joint, impaired wrist function prior to trauma (e.g. rheumatoid arthritis, neurological disorders or previous malunion of the affected limb), if there was a contraindication to anesthesia, patients that could not complete the follow-up period, previous fractures of the wrist or patients that could not follow doctors instructions due to poor cognition such as patients with previous history of stroke or dementia.；

研究者信息

研究负责人姓名

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试验机构

Jinnah Postgraduate Medical Centre

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

75500

联系人通讯地址