Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- patient-perceived disability measured by the PRWE and DASH questionnaires
研究概览
简要总结
The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.
详细描述
We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).
排除标准
- •Previous displaced fracture of the distal radius.
- •Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
研究组 & 干预措施
ORIF
Open reduction and internal fixation with a volar plate
干预措施: open reduction and internal fixation with a volar plate (Procedure)
plaster treatment
Closed reduction and plaster treatment
干预措施: closed reduction and plaster treatment (Procedure)
结局指标
主要结局
patient-perceived disability measured by the PRWE and DASH questionnaires
时间窗: one year after wrist fracture
次要结局
- impairments (grip strength and range of motion compared with the uninjured wrist)(one year after wrist fracture)
研究者
Sara Severin Wahlgren
MD
Danderyd Hospital