NCT00916539已完成不适用
Non-displaced Scaphoid Fractures: A Clinical Trial of Cast Immobilization Including vs. Excluding the Thumb
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Extent of Union
研究概览
简要总结
This trial is trying to understand if immobilization of the thumb after a non-displaced scaphoid fracture affects recovery. The standard of care overseas is a cast that allows for free movement of the thumb, and in the United States it is a cast that immobilizes the thumb. This study is attempting to understand if there is a difference.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Isolated fracture of the scaphoid
- •No displacement of the scaphoid fracture on CT scan
排除标准
- •Associated ipsilateral ligament injury or fracture
- •Pregnant Patient
研究组 & 干预措施
Cast that immobilizes the thumb
Experimental
Cast that immobilizes the thumb
干预措施: Cast that immobilizes the thumb (Device)
Cast that does not immobilize the thumb
Active Comparator
Cast that does not immobilize the thumb
干预措施: Cast that does not immobilize the thumb (Device)
结局指标
主要结局
Extent of Union
时间窗: 10 weeks
The investigators looked at the extent of fracture union after immobilization.
次要结局
- DASH Questionnaire(6 months)
- Modified Mayo Wrist Score(6 months)
- Grip Strength(6 months)
- Visual Analog Scale for Pain(6 months)
- Range of Motion: Flexion(6 months)
- Range of Motion: Extension(6 months)
- Range of Motion: Ulnar Deviation(6 months)
- Range of Motion: Radial Deviation(6 months)
研究者
David C. Ring, MD
Principal Investigator; Director of Research, Hand Service
Massachusetts General Hospital
研究点 (1)
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