Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Shoulder function
研究概览
简要总结
The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.
详细描述
Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity.
There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a completely displaced middle third clavicle fracture, no cortical contact between main fragments
- •fresh fracture, treatment within seven days after injury
- •age between 18 and 70 years
- •provided informed consent
排除标准
- •fracture was not dislocated
- •multiple injured patient
- •associated neurovascular injury, or suspicion of it
- •reduced cooperation
- •cancer or any severe illness impairing health
- •pathological fracture
- •treatment seven days after injury
- •open fracture
- •corticosteroid or immunosuppressive medication
- •upper extremity fracture at same time
- •an earlier clavicle or shoulder region fracture
- •pregnancy
- •lack of consent
结局指标
主要结局
Shoulder function
时间窗: Two years
Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.
次要结局
- Complications(Continous till two years)
- Disabilities of the Arm, Shoulder and Hand (DASH)(Two years)
- Pain at rest and at activity(Two years)
- Pain at rest and activity(Six weeks)
- Disability of the Arm, Shoulder and Hand (DASH)(One year)
- Fracture healing(Two years)