Utilizing the Retrograde Femoral Nail-Advanced for Fixation of Distal Femur and Femoral Shaft Fractures: A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Healing Rates
研究概览
简要总结
This project consists of a prospective and retrospective case series design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have a distal femur or femoral shaft fracture requiring surgical fixation. Patients who consent to study participation will recieve the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation. Data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. Given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Distal femur or femoral shaft fracture requiring surgery
- •Evaluation and treatment at UCSD
- •Age 18 years or older
- •Ability to understand the content of the patient information/Informed Consent Form
- •Signed and dated IRB-approved written informed consent
排除标准
- •Any not medically managed severe systemic disease
- •their doctor has decided that it is in the patient's best interest to receive a different method of fixation
- •Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
- •Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it
- •Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
研究组 & 干预措施
Retrograde Femoral Nail-Advanced
干预措施: RFN-Advanced Retrograde Femoral Nailing System (Procedure)
结局指标
主要结局
Healing Rates
时间窗: 2 years
次要结局
- Pain Score (0-10,0=no pain, 10=most severe)(1 year)
- Number of Complications(1 year)
研究者
William Kent
Assistant Professor of Orthopaedic Surgery
University of California, San Diego