A Prospective Cohort of Displaced Adolescent Midshaft Clavicle Fractures: Are Times to Return to Activities and Functional Outcomes Reasonable for This Population?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Malunion and/or non-union in this cohort
研究概览
简要总结
Outcomes for displaced midshaft clavicle fractures in adolescents are not defined. The current method of treatment for these fractures is non-operative management. There is recent Level 1 evidence in the adult literature to suggest that outcomes are superior when these fractures are managed surgically with open reduction and internal fixation.
详细描述
The study is a prospective observational cohort design of the natural history of adolescent clavicle fractures treated at the McGill University Health Centre. Surgeon choice will dictate treatment. There is no difference from the current normal therapy choice of each individual surgeon. Patients will be offered either operative or conservative management.
Operative Treatment: Patients with displaced midshaft clavicle fractures will be offered operative treatment which involves open reduction and internal fixation with a plate. This is the standard treatment for completely displaced fractures in the adult population at our Institution based on Level 1 evidence.
Conservative care: Patients will be treated in a sling for the acute phase of two weeks with progressive physiotherapy.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-18 years old
- •The only fracture present in that upper extremity
- •Individual and/or parents able to comply with follow-up
排除标准
- •Head injury
- •Prior injury, degenerative condition or congenital condition of the upper extremities
- •Systemic disease that may impair healing
- •Incapable of ensuring follow-up
结局指标
主要结局
Malunion and/or non-union in this cohort
时间窗: 3 months
Radiographic evaluation
次要结局
- Times to union (clinical and radiographic) following fracture(3 months)
研究者
Edward Harvey
Orthopaedic Surgeon
McGill University Health Centre/Research Institute of the McGill University Health Centre