Evaluating the Efficacy of the TracPatch Wearable Technology on Patients Undergoing Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Range of Motion
研究概览
简要总结
Total Knee Arthroplasty is becoming an increasingly common operation. An important part of a successful overall patient outcome is regaining functional range of motion after surgery. Wearable devices for fitness have become increasingly common. This study seeks to utilize wearable technology to enhance the post-operative rehabilitation experience by allowing patients and surgeons to monitor patient recovery in real time. The Consensus TracPatch is a wearable device which utilizes an accelerometer, temperature sensor and step count to monitor patient recovery. This tool provides critical, real-time information that may offer a more complete source of data to understand a patient's postoperative clinical and rehabilitation course and guide physician postoperative management. The study hypothesizes that this new technology will improve patient postoperative mobility and patient-physician communication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Surgical candidate for total knee arthroplasty
- •Greater than 18 years of age
- •Have signed the written informed consent form
- •Have consistent access to an iOS or Android device with Bluetooth capability
排除标准
- •Unwilling or unable to provide consent
- •Not fluent in the language of the informed consent form (English and Spanish)
- •Prisoners
- •Pregnant women
- •Wards of the state
- •Have previously undergone a TKA on that ipsilateral knee
- •Deformities of > 10 degrees valgus or varus or flexion contractures of > 10 degrees.
- •Considered by the surgeon to be a complex arthroplasty
研究组 & 干预措施
Wearable Technology Group
Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.
干预措施: Consensus TracPatch (Device)
Current Standard of Care Group
Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.
结局指标
主要结局
Range of Motion
时间窗: Up to 6 weeks after surgery
Range of motion, including flexion and extension of the knee will be measured with a goniometer in degrees. Measured in degrees, the patients range of motion in the operative knee will be measured before surgery and continuously by the TracPatch monitor up to six weeks post-operatively.
次要结局
- Visual Analogue Score(Up to 6 weeks after surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)(Up to 6 weeks after surgery)
- Patient-Reported Outcome Measurement Information System (PROMIS)(Up to 6 weeks after surgery)
研究者
Victor Hugo Hernandez
Assistant Professor, Arthroplasty & Joint Reconstruction
University of Miami