Intramedullary Nailing for Treatment of Unstable InterTrochanteric (INTUIT) Hip Fracture Outcome Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 92
- 试验地点
- 5
- 主要终点
- Mobility function as defined by the Timed Up & Go (TUG) frequency.
研究概览
简要总结
The primary objective of this study is to characterize patients' course of recovery in the year following the initial surgery for unstable intertrochanteric hip fractures treated with the InterTAN intramedullary hip screw device. This will be done by collecting patient outcome measures of health related quality of life and functional status including return to normal gait. Secondary objectives are to document any adverse events associated with the procedure, and to analyze differences in recovery due to differences in age, gender, co-morbidities, nutrition, residence and ambulation status, and use of mobility aids.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral unstable intertrochanteric hip fracture without other lower extremity fractures.
- •Community and household ambulators with or without assistive devices.
- •Age 50 years or greater.
排除标准
- •Stable intertrochanteric hip fracture.
- •Bilateral or two or more lower extremity fractures.
- •Non-functional ambulators or non-ambulators.
- •Age less than 50 years.
结局指标
主要结局
Mobility function as defined by the Timed Up & Go (TUG) frequency.
时间窗: Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months
次要结局
- EuroQol(Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months)
- Lower Extremity Activity Scale(Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months)
- Visual Analogue Score (VAS)(Baseline, Post-Operatively at 2 Weeks, 6 Weeks, 3 Months, 6 Months and 12 Months)
- Adverse Event(When necessary)