Does an Active Range of Motion Monitor Improve Outcomes and Decrease Cost for Patients Undergoing Total Knee Arthroplasty?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Veterans RAND 12 (VR-12)
研究概览
简要总结
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA.
详细描述
The purpose of this study is to study the efficacy of a remote range of motion monitor, the Knee Glider, alongside a patient engagement platform, Force Therapeutics, on clinical improvements and cost following primary TKA. Patients will be given the opportunity to participate, and enrolled and consented participants will be treated and followed by physicians from OSI Orthopedic & Sports Medicine. Upon consent, patients will be randomized to receive the active range of motion monitor (the knee glider) two weeks prior to surgery, near day of surgery to use postoperatively, or standard of care (no knee glider). All patients enrolled in the study will have access to Force Therapeutics, patient engagement and outcome collection system utilized by OSI Orthopedic & Sports Medicine. Enrolled subjects will be followed from the time of consent, through 6 months following surgery. Patients who are randomized into groups receiving the knee glider will receive the knee glider for up to 4 weeks following surgery, and compliance will be monitored. The hypothesis of this study is that patients who utilize an active range of motion monitor (the knee glider) will have improved clinical outcomes over patients receiving standard of care.
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
- Single (Participant)
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 who have undergone Total Knee Arthroplasty (TKA) and have agreed to participate in this study.
排除标准
- •Individuals who have not undergone TKA.
结局指标
主要结局
Veterans RAND 12 (VR-12)
时间窗: 6 Months Post Op
The Veterans RAND 12 Item Health Survey (VR-12) is a patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Discharge Services Utilization & Cost
时间窗: 12 Weeks Post Op
The Discharge Services Utilization \& Cost survey is intended collect patient discharge information. The survey consists of 16 questions asking about where they went for physical therapy, how much it costs, and if any adverse events resulted in admission to an Emergency Room or Urgent Care.
Knee Injury and Osteoarthritis Outcome Score (KOOS Jr.)
时间窗: 6 Months Post Op
Intended to elicit people's opinions about the difficulties they experience due to problems with their knee and covers aspects of pain, functional limitations and knee-related quality of life. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Range of Motion via the Knee Glider
时间窗: 12 Weeks Post Op
Daily Knee Flexion and Extension for the duration of utilizing the knee glider
Knee Glider Satisfaction
时间窗: 12 Weeks Post Op
The Knee Glider Satisfaction questionnaire is a 4 question survey asking about patient experience using the glider.
Baseline Patient Characteristics
时间窗: Baseline
Intended to collect patient demographics, contact information, birth date, surgery date, age and other baseline demographic variables.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 6 Months Post Op
1. The WOMAC is a disease-specific tool used for people with hip or knee OA to measure physical function, pain, and stiffness in the past 48 hours. 2. The WOMAC is a self-administered instrument containing 24 items measuring 3 subscales: physical function (17 items), pain (5 items), and stiffness (2 items). 3. Scores can be calculated for each subscale and a total score is calculated by adding all 3 subscale scores. Higher points signify higher levels of functional difficulty.
Force Patient Engagement
时间窗: 6 Months Post Op
Engagement on the patient engagement platform including logins, exercise videos watched and patient recorded outcome measures (PROM) compliance during platform access
Range of Motion (Exam / Patient Reported)
时间窗: 12 Weeks Post Op
a. Knee Flexion and Extension via in clinic exam or patient reported via the Force Therapeutics Platform (0 to 110 degrees)
Daily NRS Pain (Continuous)
时间窗: 12 Weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain
Total Joint Replacement (TJR) Satisfaction
时间窗: 6 Months Post Op
The TJR Satisfaction survey intends to understand patient experience and satisfaction results with their total joint replacement procedure.
次要结局
未报告次要终点