Home Monitoring After Primary Total Knee Arthroplasty
2022年1月14日 更新者：Carlos Higuera-Rueda、The Cleveland Clinic
Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Home monitoring technologies have recently emerged in many different areas of healthcare.
These technologies are being used to provide rehabilitation to patients, and to prevent, identify, and manage complications.
The investigators are proposing a method to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty (TKA) using an electronic home-based patient monitoring system with unique connectivity capabilities and prescriptive controls.
The investigators will prospectively, electronically capture range of motion and gait parameters at specified intervals using Bluetooth sensors worn by the patient.
The unique in-home patient monitoring platform will be utilized by 10 TKA patients once they return home following surgery.
The investigators hypothesize that the use of an internet based home patient monitoring technology platform will reliably provide information related to the patients' pain and function and enhance patient feedback and communication after TKA.
The hypothesis will be tested with the following aim: 1) To test the reliability of all technology utilized within the patient's home including but not limited to the sensors, the communication controller, the patient interface (Android tablet) and the internet by prospectively comparing between data collected through the home monitoring technology and traditional clinical measurements taken during physical therapy and surgical follow-up visits.
研究概览
详细说明
Over one million primary total hip and total knee arthroplasty (TKA) surgeries are being performed annually in the U.S. and this number is expected to increase over the next seven years, along with a simultaneously projected shortage of trained orthopaedic surgeons to care for these patients.
This proposal addresses the optimization of the surgeons' clinical time through utilization of innovative home based technologies to monitor and communicate with patients during the first 12 weeks after total knee arthroplasty.
This will be accomplished by establishing home monitoring connectivity with novel technology and measure validated patient-reported outcomes, knee ROM and gait parameters in a postoperative TKA patient's native living environment.
It will allow the investigators to prospectively, electronically capture clinically relevant TKA outcomes at the patient's home and provide insight into postoperative rehabilitation progress, predictors of suboptimal clinical outcomes, and guide future randomized controlled trial development to improve outcomes.
研究类型
介入性
注册 (实际的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Ohio
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Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Unilateral primary TKA
- Surgery is performed at Cleveland Clinic Main Campus or at Lutheran Hospital
- Patient must reside within 75 miles (driving distance) from Cleveland Clinic Main Campus
- Patient expected to utilize Cleveland Clinic Home Care Services after surgery
Exclusion Criteria:
- Revision or simultaneous bilateral TKA
- English is not the patient's preferred language for healthcare discussions
- Currently participating in any other research study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：At-Home Monitoring
Patients will follow-up in clinic postoperatively at 4, 8, and 12 weeks and their recovery will also be monitored using sensors and communication devices while they are at home after surgery.
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Patient reported outcomes, functional measures such as the maximum attainable range of motion (AROM) and the number of steps taken will be tracked using sensors worn by the patient.
The AROM sensor values will be verified with range of motion measurements taken using a goniometer during therapy and MD visits.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall Reliability of Monitoring Technology, Measured as Proportion of Actual Data Received From the Patient's Home Compared to the Amount of Data Expected (Based on Activities That Were Reported as Completed by Patients) Over the 12 Week Study Period.
大体时间：daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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The investigators will determine the reliability of the at-home monitoring technology for recording and transmitting data from the patient's home to the healthcare provider. This will be measured for each patient individually and then combined to form an aggregate measurement. Reliability of the technology to collect data was calculated for each patient individually by counting the number of times data (range of motion, TUG test results, VAS Pain score, etc) was received and dividing that number by the number of times data was expected (activities reported as complete by patients). This was then converted into a percentage. Additionally, this number was aggregated by combining the numerators (activities received) for all patients and denominators (activities complete) for all patients and determining the overall reliability of the technology. |
daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rehab Compliance
大体时间：Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
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Percentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions
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Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins
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Change From Preoperative to Postoperative Knee Range of Motion
大体时间：Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change from Preoperative to Postoperative Knee Range of Motion, Knee range of motion is recorded daily using sensors above and below the knee.
Please note: only data from sensors is being reported
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change From Preoperative to Postoperative Timed Up and Go Test
大体时间：Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Change from Preoperative to Postoperative Timed Up and Go Test.
The time that a patient takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
This time was recorded electronically by the patient at home using the tablet.
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)
大体时间：Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Knee-related pain was measured using a visual analog scale with numeric values added to the line.
Zero (0) is the minimum value and 10 is the maximum value.
A score of 0 indicates no pain and a score of 10 indicates the worst pain imaginable.
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Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain
大体时间：Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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We will assess KOOS Pain using 9 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 36 points.
This score will be normalized to a 100 point scale where 100 means no pain and 0 is extreme pain.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)
大体时间：Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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We will assess KOOS Function using 7 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 28 points.
This total will be normalized to a 100 point scale where 100 means no functional difficulty and 0 is extreme difficulty.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL
大体时间：Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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We will assess KOOS QOL using 4 questions, each response given a point value from 0 to 4. The sum of these points will total between 0 and 16 points, which will then be normalized to a 100 point scale.
One hundred (100) means the knee does not affect quality of life and 0 indicates that the knee is a constant problem affecting quality of life.
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Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Carlos Higuera, MD、Staff Surgeon
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年7月1日
初级完成 (实际的)
2017年5月2日
研究完成 (实际的)
2017年5月2日
研究注册日期
首次提交
2016年7月28日
首先提交符合 QC 标准的
2017年1月24日
首次发布 (估计)
2017年1月26日
研究记录更新
最后更新发布 (实际的)
2022年1月18日
上次提交的符合 QC 标准的更新
2022年1月14日
最后验证
2022年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.