Radiographic and Clinical Comparison of Post-reduction Splinting Constructs in the Treatment of Acute Displaced Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Displacement of fracture, measured by volar tilt
研究概览
简要总结
Subjects with acute, displaced distal radius fractures will be randomized at the time of emergency room evaluation to one of two commonly accepted splinting methods for displaced distal radius fractures: sugar tong splints or volar/dorsal clam shell splints. Reduction will be performed in the usual, standard fashion and the selected splint applied. Standard radiographic measurements of alignment, including radial height, volar tilt and inclination will be measured on pre- and post- reduction radiographs by a single reviewer- who will be blinded to splint application type. At the first fracture follow-up visit, typically occurring between 5-10 days, as in standard practice, repeat radiographs of the wrist will be taken, and the same reviewer will measure alignment. As a secondary outcome, patients will also complete the disabilities of the arm, shoulder and hand (DASH) questionnaire at this visit, to compare patients' ability to perform activities of daily living with their respective splints.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute, displaced distal radius fracture
- •isolated injury
排除标准
- •polytrauma
- •non-displaced fracture
- •prior wrist fracture
结局指标
主要结局
Displacement of fracture, measured by volar tilt
时间窗: 1 Week
\> 5 degrees of radial inclination lost from immediate post-reduction radiographs A t-test will be performed with a p value \< 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Displacement of fracture, measured by radial height
时间窗: 1 Week
\>2 mm of radial height lost from immediate post-reduction radiographs A t-test will be performed with a p value \< 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Displacement of fracture, measured by radial inclination
时间窗: 1 Week
\> 10 degrees of volar tilt lost from immediate post-reduction radiographs A t-test will be performed with a p value \< 0.05 to determine significance in loss of reduction A t-test will also be performed comparing individual parameters between the 2 splinting methods
Disabilities of the Arm, Shoulder,and Hand (DASH) outcome score
时间窗: 1 Week
30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
次要结局
未报告次要终点