A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 主要终点
- intraoperative reduction time
研究概览
简要总结
In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.
详细描述
In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.
排除标准
- •patients refused to participate in the clinical trial;
- •condylar fracture dislocation was not obvious, conservative treatment can be used;
- •mandibular condylar comminuted fracture;
- •mandibular condyle need to be reconstructed.
结局指标
主要结局
intraoperative reduction time
时间窗: intraoperative
次要结局
未报告次要终点
研究者
Junhui Cui
Principal investigator
West China Hospital