- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03032068
Home Monitoring After Primary Total Knee Arthroplasty
Feasibility of Home Monitoring After Primary Total Knee Arthroplasty
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehab Compliance
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos Higuera, MD, Staff Surgeon
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-1051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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