Open Reduction and Internal Fixation of Lateral Humeral Condyle Fractures With Absorbable Screws in Children
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 主要终点
- Elbow Motion angle in degree
研究概览
简要总结
Lateral humeral condyle fractures are the second most common elbow fractures in children. Displaced and rotated fractures require stabilization and reduction. Kirschner wires (K-wires) are most commonly used for fracture fixation. Here, the investigators introduce a new fixation method involving absorbable screws. The investigators aimed to determine if it is feasible to treat lateral humeral condyle fractures with absorbable screws by comparing the functional outcomes obtained using screw fixation vs. K-wire fixation.
详细描述
Methods: Between May 2007 and September 2010, 86 participants (age, 1.6-13 years; average age, 6.7 years) were randomly divided into two groups. All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III. Closed reduction failed in all participants. Therefore, open reduction was performed under general anesthesia. One absorbable screw was used for fixation in the experimental group, while two 1.8-mm K-wires were used in the control group. At 4-6 weeks postoperatively, the participants' plaster casts were removed, and functional training was started.
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
- Single (Investigator)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants had been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
排除标准
- •participants had not been diagnosed with lateral condyle fractures classified as Jacobs type II (unstable) or III
结局指标
主要结局
Elbow Motion angle in degree
时间窗: 6 months after surgery.
The orginal position was anatomy position （neutral position），Then，test the angle measured in degree of the elbow motion flexion, pronation and supination
Strength in Newton (N)
时间窗: 6 months after surgery.
Compared to the normal hand, the investigators defined it normal to moderate loss and severe loss
Pain
时间窗: 6 months after surgery.
According to the level 0 \~ 10 to pain grading:0 to 3 for mild pain,4 to 6 for moderate pain,7 or more for severe pain
stability
时间窗: 6 months after surgery.
Compared to the normal hand, the investigators defined the elbow stability from normal to mild loss , moderate loss and severe loss
次要结局
未报告次要终点
研究者
Yuxi Su
Vice chief of the orthopeadic department of Children's Hospital of Chongqing Medical Univeristy
Children's Hospital of Chongqing Medical University