NCT05370365已完成不适用
Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?
Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Patient Rated Wrist Evaluation (PRWE)
研究概览
简要总结
The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Data from the demographic data collection and the outcome parameters will be cleaned blindly from the treatment data
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 65 years with a low energy distal radius fracture
- •Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
- •Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm)
排除标准
- •History of ipsilateral fracture
- •Bilateral fracture
- •Open fracture
- •Other concomitant fracture (except ulnar styloid fracture)
- •Fracture AO B
- •Previous surgeries in this area
结局指标
主要结局
Patient Rated Wrist Evaluation (PRWE)
时间窗: 1 year
The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.
次要结局
- Quick Disability of Arm and Shoulder (QuickDASH)(1 year)
- Visual Analogue Scale (VAS)(1 year)
- Range Of Movement (ROM)(1 year)
- Complications(1 year)
研究者
研究点 (2)
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