Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- AOFAS score
研究概览
简要总结
Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.
详细描述
Comparative study for ankle fracture combined with deltoid ligament rupture: with & without repair of ligament
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ankle fracture with deltoid ligament rupture
排除标准
- •ankle fracture without deltoid ligament rupture
结局指标
主要结局
AOFAS score
时间窗: 12 months after surgery
次要结局
未报告次要终点
研究者
Liming Cheng
Director, Head of orthopedics, Pricipal investigator, Clinical professor
Shanghai Tongji Hospital, Tongji University School of Medicine
