Type II Pediatric Supracondylar Humerus Fracture Management and Outcomes: A Prospective Multi-centre Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Change in Lateral Humerocapitellar Angle
研究概览
简要总结
The treatment of pediatric supracondylar humerus fractures is controversial, but despite the injury's high incidence there is a lack of high level evidence to guide operative versus non-operative decision making for displaced fractures with an intact posterior cortex (Gartland Type II). This study aims to prospectively compare clinical, functional, and radiographic outcomes between operatively and non-operatively treated patients using a prospective multi-centre cohort design.
详细描述
Purpose:
The purpose of this prospective multi-center observational study is to compare the clinical, functional, and radiographic parameters and outcomes between operatively and non-operatively treated Type II supracondylar humerus fractures in skeletally immature patients. The secondary aim of the study is to develop and deploy an effective pediatric orthopaedic elbow trauma database as part of the Canadian Pediatric Orthopaedic Group (CPOG) that can be used to prospectively collect multi-center anonymized patient data and functional outcomes.
Hypothesis:
We hypothesize that non-operative treatment will be non-inferior to operative treatment.
Justification:
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
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 2-12 years
- •Isolated supracondylar humerus fracture
- •Gartland Type II extension-type fracture
- •Closed injury
排除标准
- •Neurovascular compromise
- •Underlying musculoskeletal disorder
结局指标
主要结局
Change in Lateral Humerocapitellar Angle
时间窗: 3 months
Change in the LHCA over the period of immobilization is the primary outcome being measured in this study, and will be measured on all radiographs. Maintenance of fracture reduction is assessed by the change in the LHCA between these two radiographs. This angle primarily assesses the reduction in the sagittal plane and thus is most sensitive to flexion and extension. The normal LHCA is considered to be 30 degrees of anterior angulation. It has been shown that with changes of less than 10 degrees, good elbow function can still be expected.
次要结局
- Baumann's Angle(3 months)
- Flynn's Elbow Score(1 year)
研究者
Christopher Reilly
Associate Professor
University of British Columbia