Efficacy of Self - Adjustable Clavicular Brace Versus Standard Clavicular Brace for Treatment of Mid Shaft Clavicle Fracture: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- DASH
研究概览
简要总结
A randomized control trial was conducted to compare the outcomes of conservative management for closed midshaft clavicular fractures using self-adjustable clavicular brace and standard clavicular brace.
详细描述
Ten patients aged 18-75 years with midshaft clavicle fractures were enrolled in the study during February 2022 to February 2023. 6 patients were managed with standard clavicular brace and 4 patients with self-adjustable clavicular brace. All patients were scheduled for follow-up appointments at 1 week, 2 weeks, 4 weeks, 6 weeks and 12 weeks. Results were assessed based on clinical, functional and radiographic outcomes using the DASH questionnaire, pain, measured by VAS, analgesic usage, displacement, shortening, time to union, and patient satisfaction,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with aged between 18 - 75 years old
- •Closed isolated fracture midshaft of clavicle within 9 days after the injury date
排除标准
- •After bracing, fracture displacement and/or shortening > 2 cm or fracture comminution > 3 fragments
- •Segmental fracture
- •Open fracture
- •Impending open fracture (soft tissue compromise/skin lesion)
- •Ipsilateral upper extremities fracture which disturbs clavicular bracing
- •Floating shoulder which surgical treatment is indicated.
- •Patients with other injuries (e.g. head injury, chest and abdomen injury) which interrupted clavicular bracing
- •Pathologic fracture
- •Patient has limitation for clavicular brace application
- •Pregnant women
研究组 & 干预措施
standard clavicular brace
干预措施: Clavicular brace (Device)
self-adjustable clavicular brace
干预措施: Clavicular brace (Device)
结局指标
主要结局
DASH
时间窗: 1, 2, 4, 6, 12 week
DISABILITIES OF THE ARM, SHOULDER AND HAND
次要结局
- Pain, analgesic usage, radiographic outcomes, time to union, and patient satisfaction(1, 2, 4, 6, 12 week)
研究者
Thanachai Klongsangsorn
MD
Prince of Songkla University