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临床试验/NCT03154424
NCT03154424已完成不适用

Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study

Faculdade de Medicina do ABC0 个研究点目标入组 150 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
主要终点
Grip strenght

研究概览

简要总结

A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).

详细描述

Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested.

Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.

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, Care Provider, Investigator)

盲法说明

Patients were randomized by drawing lots currency (Face = A - treatment with fixation "non-bridging"; Crown = B - Treatment with the method "bridging"), which were printed and placed in sealed envelopes before the study started.

入排标准

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

入选标准

  • skeletally mature patients, elderly (60 y.o. or more)
  • all with a diagnosis of unstable distal radius fractures (AO type A or C)
  • associated a multiple injured ( polytrauma ).

排除标准

  • ongoing chemo or radiotherapy,
  • mental illness,
  • alcohol abuse.

结局指标

主要结局

Grip strenght

时间窗: 12 months

use the specific Jamar Hand Dynamometer to measure the arc of movement the wrist

次要结局

  • VAS (visual analog scale)(12 months)
  • range of wrist motion(12 months)
  • DASH Questionnaire(12 months)
  • Radiograph assesment(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcio Aurelio Aita

Affiliated Professor

Faculdade de Medicina do ABC

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