Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Foot and ankle Outcome Score (FAOS)
研究概览
简要总结
This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Individuals receiving ORIF or PA for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at The University of Kansas Medical Center (KUMC) or Emory University Hospital.
排除标准
- •Anyone under the age of 18 years. Pregnant women.
结局指标
主要结局
Foot and ankle Outcome Score (FAOS)
时间窗: Collected only once; from 6 months post-op up to date of death from any cause
Foot and ankle injury patient reported outcome measure (Scores range from 0 to 100, with higher scores indicating better foot and ankle surgical outcomes)
Ankle range of motion
时间窗: Collected only once; from 6 months post-op up to date of death from any cause
Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors
Walking cadence
时间窗: Collected only once; from 6 months post-op up to date of death from any cause
Steps per minute as determined by the use of the Opal Sensors
12 Item Short Form Survey (SF-12)
时间窗: Collected only once; from 6 months post-op up to date of death from any cause
Patient reported outcome measures regarding health and daily activities (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)
Timed up-and-go
时间窗: Collected only once; from 6 months post-op up to date of death from any cause
Time it takes to stand from seated, walk 10 feet forward, turn around, and sit back down, unassisted (determined by the use of the Opal sensors).
次要结局
- Return to work time(From the date of surgery up until the date of death from any cause)
- Presence of infection and/or post-traumatic arthritis(From the date of surgery up until the date of death from any cause)
- Need for secondary operation(From the date of surgery up until the date of death from any cause)
研究者
Brent Wise
Assistant Professor
University of Kansas Medical Center