NCT05825079已完成不适用
A Randomized, Parallel, Two Arm, Unblinded Single-center Study of the Effects of Patient-provided Feedback on Fracture Healing and Weight-bearing Status in Orthopedic Patients Undergoing Operative Fixation or Non-operative Treatment of Isolated Tibial Plateau, Pilon, and Other Ankle Fractures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12
研究概览
简要总结
The goal of this study is to determine if weight-bearing crutch technology that delivers active feedback to patients during their treatment will impact patient compliance with physician instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Willing and able to participate in study and complete consent
- •Will undergo treatment of an isolated tibial plateau, pilon, or ankle fracture and placed in a non-weightbearing status with the use of crutches at NYU.
- •Have access and use of a mobile phone (exclusively iOS and/or Android devices)
排除标准
- •Patients with concomitant TBI
- •Polytrauma patients
- •Pathologic fractures
- •Prisoners
结局指标
主要结局
Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12
时间窗: Week 2, Week 12
Average weight put on crutch measured using the Smart Crutch Tip.
次要结局
- Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12(Baseline, Week 12)
- Time to Recovery(Up to Week 12)
- Percent (%) of Participants with Injury Complications(Up to Week 12)
- Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity Injury(Up to Week 12)
研究者
研究点 (1)
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