Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mayo Elbow Performance Score (MEPS)
研究概览
简要总结
The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.
详细描述
The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute Lateral humeral condyle fracture
- •Fracture <5 days old
- •Fracture with <5 mm of displacement on plain radiographs
- •Parental informed consent obtained
排除标准
- •Contraindication(s) to performing an MRI
- •Unable to participate in follow-up
- •Existing bone pathology
- •Previous ipsilateral elbow fracture
结局指标
主要结局
Mayo Elbow Performance Score (MEPS)
时间窗: 2 years
MEPS consists of three domains; pain, elbow range of motion (ROM) and stability. The total score ranges from 0-100 with higher scores indicating better function. If the total score ranges between 75 and 100, the result is good (satisfactory); 50-74, fair (acceptable); \<50, poor (unsatisfactory).
次要结局
- Secondary fracture displacement(2 years)
- MRI results(2 weeks)
- Pain scale (age <5 years)(2 years)
- Pain scale (age >4 years)(2 years)
- Radiographic results(2 years)
- Pain scale (age >8 years)(2 years)
研究者
Morten Jon Andersen
Consultant Orthopedic Surgeon
Children's Fractures Interest Group, Denmark