A retrospective, multi-center, observational, real-world post-market clinical follow-up study to evaluate the safety & performance of Intramedullary nails used in the fixation of long bone fractures,including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 10
- 主要终点
- Rate of re-operation
研究概览
简要总结
Study Title: Intramedullary Nails PMCF Study: A retrospective, multi-center, observational, real-world postmarket clinical follow-up study to evaluate the safety & performance of Intramedullary nails used in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal
Study Design: A retrospective, multi-center, observational, real-world postMarket clinical follow-up study.
Objective: To evaluate the safety and performance of Intramedullary Nails used in the fixation of long bone fractures, including diaphyseal fractures in the humerus, tibia, femur, and shaft fractures 5 cm below the surgical neck, and 5 cm proximal to the distal end of the medullary canal.
Follow-ups: As this is a retrospective study, the patient’s records will be reviewed for only observations and the data will be collected over 2 years.
Indication: Intramedullary Nails indicated in the fixation of Long Bone Fractures, including Diaphyseal Fractures in the Humerus, Tibia, Femur, and Shaft Fractures 5 cm below the Surgical Neck and 5 cm proximal to the distal end of the Medullary Canal.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who have been treated with Intramedullary Nails and have completed a minimum of 02 year follow up.
排除标准
- •Asthis is a retrospective review of data, there are no formal exclusion criteria for the study.
结局指标
主要结局
Rate of re-operation
时间窗: Time Frame: Through 1 year
次要结局
- 1.Mean Operation Time in minutes(2.Post-operative hospital stay)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd