CTRI/2023/03/051079招募中4 期
A Prospective Single-arm, post marketing clinical follow-up study to evaluate the safety and performance of Fibula Plate System
Auxein Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Subject is willing and able to give written informed consent for
- •participation in the study.
- •Male or Female, aged between 18-65 years, skeletally mature patient.
- •Patient schedule for surgery after trauma using fibula plate implants.
排除标准
- •Patient with a fracture line more than 9 cm from the tip of the fibula, associated tibial pilon fractures, associated talar fractures and pathological fractures.
- •Patient with Mental Disorders as well as comprehensive legal support.
- •Lack of willingness to make a commitment to return for required follow up visits.
- •Pregnant Female.
- •Drug and/or alcohol abuse.
- •Morbid obesity.
研究者
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