A Prospective Randomized Trial Comparing the Effect of Minimally Invasive Locking Plate Fixation and Reamed Intramedullary Nail Fixation on Patients With Gustilo I-III A Open Tibia Fracture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- LEFS
研究概览
简要总结
The best treatment for the open tibia fractures remains controversial. It is unknown whether minimally invasive locking plate or reamed intramedullary nail fixation will result in lower complication rates and better function.
详细描述
The best fixation method for open tibial fractures remains controversial. The current standard treatment options recommended the use of intramedullary nail for treating such fractures. Recent studies also showed favorable results for the use of plates in managing open tibial fractures. However, it is unknown whether locking plate or intramedullary nail fixation will result in lower complication rates and better function.
This study is a prospective, randomized trial to compare the safety and efficiency of minimally invasive plate osteosynthesis and reamed intramedullary nails in treating type I-II open tibial shaft fractures. The investigators hypothesize that neither intervention resulted in a superior disability rating at 12 months. Outcomes evaluated will include the rate of infection, the number of re-hospitalization for the complication, the time to bone healing, Patient-Reported outcome and quality of life and other complications.
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
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
- •Ages 18 - 60 years inclusive
- •Open diaphyseal fracture
- •Gustilo-Anderson Type I, II, IIIA
排除标准
- •Closed, periarticular or pathological fracture
- •Gustilo-Anderson Type IIIB,IIIC
- •Patients with concomitant fractures in the ipsilateral limb
- •The patient is unable to medically tolerate general anesthesia
- •The patient is unable to provide informed consent or comply with completing questionnaires
- •Tibia already infected as diagnosed by a surgeon
- •The patient has been diagnosed with a severe psychiatric condition
结局指标
主要结局
LEFS
时间窗: 12 months
failure.
次要结局
- EQ-5D(12 months)