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
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
研究组 & 干预措施
Weight-Bearing Feedback Delivered to Mobile Phone
The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. Feedback of this data can be delivered to the patient through a mobile phone application. For Arm A of the study, feedback is delivered to the patient's paired mobile phone, providing them information on how much weight they are exerting on their crutch/injured lower extremity.
干预措施: Weight-Bearing Feedback (Behavioral)
Weight-Bearing Feedback Delivered to Mobile Phone
The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. Feedback of this data can be delivered to the patient through a mobile phone application. For Arm A of the study, feedback is delivered to the patient's paired mobile phone, providing them information on how much weight they are exerting on their crutch/injured lower extremity.
干预措施: Smart Crutch Tip (Device)
No Weight-Bearing Feedback
The weight-bearing tracking system is attached to the patient's crutch and calculates how much weight is being put on the crutch. For Arm B, no feedback about weight-bearing status is delivered to the patient.
干预措施: Smart Crutch Tip (Device)
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)