Comparison of the Minimally Invasive Surgery Versus Open Reduction in the Surgery of the Pilon Fractures
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Healing
研究概览
简要总结
The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation.
The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.
详细描述
Several surgical techniques exist and among plate osteosynthesis, there is a minimally invasive method and the open reduction method.
Investigators think that the minimally invasive method with intern plate is more efficient than the open reduction method.
These techniques may better preserve perifracture soft tissues, hematoma. It may lead to a smaller muscle detachment.
The minimally invasive technique allows a more efficient vascularization of the fracture site, what would increase bone healing and the functional prognosis of tibial pilon lesions.
It's all these issues investigators would like to assess with a randomized study.
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
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18-year-old with opened or closed pilon fracture Cauchoix type 1,
- •signed patient consent
排除标准
- •Open pilon fracture cauchoix type 2 or 3,
- •infection of the operating site,
- •previous osseous disease
- •patient who are unwilling or unable to give consent
研究组 & 干预措施
minimally invasive method
The patients are treated with minimally invasive method
干预措施: minimally invasive method (Procedure)
open reduction method
The patients are treated with open reduction method
干预措施: open reduction method (Procedure)
结局指标
主要结局
Healing
时间窗: at 45 days
Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number.
次要结局
- AOFAS clinical score(pre op, 45 days, 3, 6 and 12 months)
- Radiologic evaluation(pre op 45 days, 3, 6 and 12 months)
- The Foot & Ankle Disability Index(pre op 45 days, 3, 6 and 12 months)
- Complications(pre op 45 days, 3, 6 and 12 months)
- Nach mazur and al score(pre op 45 days, 3, 6 and 12 months)
- Pain(pre op 45 days, 3, 6 and 12 months)