Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Disability with use of QuickDASH
研究概览
简要总结
AIM:
The aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population.
NULL HYPOTHESIS:
Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway and 10.9 in the United States) 6 months after injury when treated symptomatically with a removable brace.
详细描述
Fractures of the distal scaphoid tubercle are uncommon and seem relatively benign. Not a lot is known in literature about this specific type of avulsion fracture and the treatment. Some surgeons recommend a cast for 4 to 6 weeks while others treat their patients with a removable brace. The only non-union reported in literature is Jonssen who published a case in 1990 about a non-union of a tubercle fracture in a patient with repeated trauma. Kraus et al studied 81 cases of acute scaphoid fractures and found 4 cases of tubercle avulsion fractures in this group. We suspect some patients will not seek care for this condition as it hurts for a bit and then causes no problems.
Response variables:
- Quick DASH measured 6 months after injury
- 11-point ordinal measure of overall pain intensity 6 months after trauma
Explanatory variables:
- Socio-demographics
- Age, sex, ethnicity, race, marital status, education, work status
- Questionnaires
- Quick DASH after trauma (< 2 weeks)
- 11-point ordinal measure of overall pain intensity 6 months after trauma
- 11-point ordinal measure of satisfaction with treatment 6 months after trauma
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
- •Age > 18 years
- •Fracture of the distal tubercle of the scaphoid on radiographs
- •Interval between injury and diagnosis of less than 2 months
- •English or Spanish fluency and literacy
排除标准
- •Pregnant women
- •Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)
- •Patients with other fractures or injuries
结局指标
主要结局
Disability with use of QuickDASH
时间窗: 2 weeks
次要结局
- Overall Pain Intensity(6 months)
- Satisfaction with Treatment(6 months)
研究者
David C. Ring, MD
Chief of Hand and Upper Extremity Service
Massachusetts General Hospital