NCT05668117已完成不适用
RFN-Advanced Retrograde Femoral Nailing System (RFNA) - Early Usage Case-Series Utilizing the Retrograde Femoral Nail-Advanced for Fixation and Stabilization of the Distal Femur and Femoral Shaft
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Union
研究概览
简要总结
This study is a retrospective chart review of the safety and performance Standard of Care data on individuals that have previously been implanted with the femur nail of the RFNA System for the internal fixation of the femur. Demographics, medical history, primary diagnosis, mechanism of injury, type of injury, clinical and radiographic evaluation of bone consolidation, and device-related adverse events were collected. Descriptive statistics were applied to the data collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subjects 18 years or older at the time of index procedure
- •Subjects who received the Depuy Synthes Advanced Retrograde Nail in accordance with the indications for use.
- •Subjects who have at least 6 months of follow-up.
排除标准
- •Subject with less than 6 months of follow up, pathologic fractures, and patients < 18 years of age will be excluded from the study.
结局指标
主要结局
Union
时间窗: 6 months
Rate of fracture union
次要结局
- Malunion(6 months)
- Implant breakage(6 months)
- Infection(6 months)
- Implant removal(6 months)
研究者
Clay Spitler
Associate Professor
University of Alabama at Birmingham
研究点 (1)
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