Treatment of Medial Humeral Epicondyle Fractures in Children With Absorbable Cartilage Nails
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Pain Intensity
研究概览
简要总结
To compare surgical outcomes from medial epicondyle fracture fixation with absorbable cartilage nails to those from traditional Kirschner wire fixation.
详细描述
From August 2007 to January 2012, 32 patients undergoing surgery for medial humeral epicondyle fractures in our hospital were randomized into group A (traditional Kirschner wire) or group B (absorbable cartilage nail). The same surgical team performed the operations, and patients were followed for over a year. Group A had open reduction with K-wire fixation, and group B was fixed with absorbable cartilage nails. The Bede scoring system was used to evaluate elbow function at follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fractures with more than 2 mm of displacement were treated with cast immobilization
排除标准
- •fractures with less than 2 mm of displacement were treated with cast immobilization
研究组 & 干预措施
absorbable cartilage nail Group
10 males and 7 females, ages 7-15 years (average, 11.8), and 3 patients with elbow dislocation, the fractures were fixed by absorbable cartilage nail
干预措施: absorbable cartilage nail (Procedure)
traditional Kirschner wire Group
10 males and 5 females, ages 8-14 years (average, 12.6), and 4 patients with elbow dislocation, the fractures were fixed by traditional Kirschner wires
干预措施: traditional Kirschner wires (Procedure)
结局指标
主要结局
Pain Intensity
时间窗: on 12th month
Pain Intensity assessed with the Bede Scoring System
Elbow Motion
时间窗: on 12th month
Elbow Motion assessed in degrees
Stability
时间窗: on 12th month
Stability assessed using the following scoring system: Stable, Moderate Instability, Grossly Unstable.
Elbow Function evaluation
时间窗: on 12th month
A specific physician check the patients and ask them to perform the following activity.(comb hair,eat;perform hygiene;don shirt;don shoe)
次要结局
未报告次要终点
研究者
Guoxin Nan
Vice President of Department orthopeadic department
Children's Hospital of Chongqing Medical University