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【ChiCTR2000032970】Plaster Immobilization versus Volar Plating for Distal Radius Fractures in the Superelderly

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基本信息

登记号

ChiCTR2000032970

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

2020-05-17

临床申请受理号

靶点

适应症

远端骨折

试验通俗题目

Plaster Immobilization versus Volar Plating for Distal Radius Fractures in the Superelderly

试验专业题目

Plaster Immobilization versus Volar Plating for Distal Radius Fractures in the Superelderly

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

We hypothesise that in this age group, casting is as effective as surgical management in clinical outcomes and therefore may be preferable in the super elderly for whom the risk of anaesthesia would be significant

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

The patients were randomly allocated by a computer in a 1:1 ratio to open reduction and volar plate fixation or plaster immobilization stratified by AO fracture type, gender, number of comorbidities, body mass index, American Society of Anesthetist grade.

盲法

Open label

试验项目经费来源

Nil

试验范围

目标入组人数

87;72

实际入组人数

第一例入组时间

2016-05-27

试验终止时间

2020-03-14

是否属于一致性

入选标准

Patients aged 75 years and older with an isolated closed unilateral distal radius fracture were included in the study. These fractures were either: 1. Extra-articular fractures, having a dorsal displacement of more than 20 degrees (with or without a displaced intra-articular component) with dorsal cortical comminution as seen on the lateral radiograph; 2. Displaced intra-articular fractures with an articular step-off or gap in the radiocarpal joint surface.；

排除标准

1. Patients with an unacceptable closed fracture reduction; 2. Multiple injuries; 3. Patients with open distal radius fractures; 4. Other fractures of the affected extremity (except for a fracture of the ulnar styloid process); 5. Patients with impaired wrist function prior to trauma (e.g. rheumatoid arthritis, neurological disorders or previous malunion of the affected limb); 6. Proximal metaphyseal fractures (>2.5 cm from the articular surface); 7. Substantial pre-existing radiographic abnormality; 8. AO type B; 9. Bilateral injuries; 10. Previous fractures of the distal part of the radius of the same or contralateral limb; 11. Patients who are unable to consent to treatment.；

研究者信息

研究负责人姓名

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试验机构

巴基斯坦卡拉齐真纳教学医学中心研究生医学中心

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