A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Grip strength
研究概览
简要总结
Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires.
At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint
- •The treating Consultant surgeon believes that they would benefit from operative fixation of the fracture
- •Aged over 18years (either sex) and able to give informed consent
排除标准
- •The fracture extends more than 3 cm from the radio-carpal joint
- •The fracture open with a Gustillo grading greater than 1
- •There are contra-indications to general anaesthetic
- •There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
结局指标
主要结局
Grip strength
时间窗: 1 year post-operatively
Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
次要结局
- Pinch strength(1 year post-operatively)
- Wrist arc motion(1 year post-operatively)
- Patient rated wrist evaluation (PRWE)(1 year post-operatively)
- Disabilities of Arm, Shoulder and Hand Score (DASH)(1 year post-operatively)
- EQ-5D(1 year post-operatively)
研究者
Caroline Plant
Mrs Caroline Plant
University of Warwick