Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study
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
- 是
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
Marcio Aurelio Aita
Affiliated Professor
Faculdade de Medicina do ABC
