临床试验/NCT02798614

NCT02798614已完成不适用

A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures

Uppsala University Hospital0 个研究点目标入组 109 人开始时间: 2002年9月最近更新: 2016年6月16日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Uppsala University Hospital
入组人数: 109
主要终点: Radiographic displacement

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.

详细描述

Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months

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: None

入排标准

年龄范围: 50 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Distal radius fracture with intact ulna (except for processus styloideus ulnae)
•Dorsal angulation 5-40 degrees
•Axial compression < 4 mm
•Intra articular step-off < 1 mm
•Low energy trauma
•Closed fracture
•Suitable for treatment with closed reduction and plaster cast fixation

排除标准

•Fracture older than 3 Days
•Previously fractured ipsi- or contralateral wrist
•Inflammatory joint disorder

结局指标

主要结局

Radiographic displacement

时间窗: At admission, 10 days, 1 month and 12 months

Change in dorsal angulation, radial angulation and axial compression between follow-ups.

次要结局

Assessment of pain intensity(10 days, 1, 4 and 12 months)
Range of motion(Uninjured side. Injured side at 1, 4 and 12 months)
Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.(12 months)
Grip strength(Uninjured side. Injured side at 1, 4 , 12 months)

研究者

发起方

Uppsala University Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Albert Christersson

Uppsala University Hospital

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