Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Range of motion
研究概览
简要总结
Clavicle fractures in children are common. Typical treatment includes nonoperative treatment with a sling. Operative treatment is usually limited to open, unstable, fractures with either epidermal risks or neurovascular compromise. Orthopaedic literature has many studies that report the need for additional research for this prevalent fracture. This is an observational study evaluating the functional and patient reported outcomes of displaced clavicle fractures in adolescents. The results from this study will help the orthopedist understand the expected outcomes for a given pediatric patient with a clavicle fracture.
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
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-17 years old with fractures of the middle third of the clavicle
- •Displaced 100% the width of the clavicle or shortened 1 centimeter
- •Operative and non-operative treated clavicles will be eligible for enrollment
排除标准
- •Open clavicle fractures
- •Ipsilateral shoulder injuries
- •Fractures involving the lateral ligaments or the sternoclavicular joint
- •Bilateral clavicle fractures
- •Pathologic fractures
- •Refractures
- •Fractures with neurovascular compromise
- •Displaced fractures with impending skin compromise
- •If there has been more than 21 days between injury and enrollment
- •Patients with cognitive disabilities that inhibit the completion of the questionnaires
结局指标
主要结局
Range of motion
时间窗: at 1 year post injury
Range of motion measured by goniometer
Radiographic healing
时间窗: at 1 year post injury
Radiographic evidence of healing on 3 of 4 cortices
次要结局
- QuickDash(at 3 months, 6 months and 12 months)
- PODCI(at 3 months, 6 months and 12 months)