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Home Monitoring After Primary Total Knee Arthroplasty

Feasibility of Home Monitoring After Primary Total Knee Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03032068
Enrollment
10
Registered
2017-01-26
Start date
2016-07-31
Completion date
2017-05-02
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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.

Detailed description

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.

Interventions

OTHERAt-Home Monitoring

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.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurredThe 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.

Secondary

MeasureTime frameDescription
Change From Preoperative to Postoperative Knee Range of MotionOnce preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurredChange 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
Change From Preoperative to Postoperative Timed Up and Go TestOnce preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurredChange 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.
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)Once preoperatively then postoperatively 2-3 times daily from the date of discharge until the 12 week postoperative follow-up appointment has occurredKnee-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.
Rehab CompliancePercentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy beginsPercentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurredWe 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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOLOnce preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurredWe 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.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PainOnce preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurredWe 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.

Countries

United States

Participant flow

Recruitment details

Patients who were scheduled for primary total knee arthroplasty from October 2016 through February 2017 and met all enrollment criteria were asked to participate.

Pre-assignment details

All participants were enrolled in the same group.

Participants by arm

ArmCount
Home-based Monitoring
All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1

Baseline characteristics

CharacteristicHome-based Monitoring
Age, Continuous67 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
9 Participants
Sex: Female, Male
Female
5 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 14
other
Total, other adverse events
0 / 14
serious
Total, serious adverse events
1 / 14

Outcome results

Primary

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.

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.

Time frame: daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred

ArmMeasureValue (MEAN)Dispersion
Home-based MonitoringOverall 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.91 percentage of received vs expected dataStandard Deviation 6
Secondary

Change From Preoperative to Postoperative Knee Range of Motion

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

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

Population: One patient was withdrawn from the study prior to the 8 week follow-up visit due to an adverse event. Therefore, only 9 patients were included in the analysis at 8 weeks and 12 weeks postoperative.

ArmMeasureGroupValue (MEAN)
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of MotionPreoperative17 degrees
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of MotionHomecare Visit 15.8 degrees
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of MotionHomecare Visit 29.7 degrees
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of MotionHomecare Visit 32.2 degrees
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of Motion4 Weeks Postoperative-1.1 degrees
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of Motion8 Weeks Postoperative13.3 degrees
Home-based MonitoringChange From Preoperative to Postoperative Knee Range of Motion12 Weeks Postoperative22.3 degrees
Secondary

Change From Preoperative to Postoperative Timed Up and Go Test

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.

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

Population: One patient was withdrawn from the study prior to the 8 week follow-up visit due to an adverse event. Therefore, only 9 patients were included in the analysis at 8 weeks and 12 weeks postoperative.

ArmMeasureGroupValue (MEAN)
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go TestPreoperative0.1 seconds difference
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go TestHomecare Visit 10.1 seconds difference
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go TestHomecare Visit 20.3 seconds difference
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go TestHomecare Visit 30.0 seconds difference
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go Test4 Weeks Postoperative-0.3 seconds difference
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go Test8 Weeks Postoperative0.6 seconds difference
Home-based MonitoringChange From Preoperative to Postoperative Timed Up and Go Test12 Weeks Postoperative0.2 seconds difference
Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain

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.

Time frame: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred

Population: One patient was withdrawn from the study prior to the 8 week follow-up visit due to an adverse event. Therefore, only 9 patients were included in the analysis at 8 weeks and 12 weeks postoperative.

ArmMeasureGroupValue (MEAN)Dispersion
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PainPreoperative41.7 score on a scaleStandard Deviation 7.8
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PainHomecare Visit 141.2 score on a scaleStandard Deviation 10
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PainHomecare Visit 254.6 score on a scaleStandard Deviation 17.2
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PainHomecare Visit 370.0 score on a scaleStandard Deviation 5
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain4 Weeks Postoperative68.5 score on a scaleStandard Deviation 16.3
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain8 Weeks Postoperative73.7 score on a scaleStandard Deviation 15.3
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain12 Weeks Postoperative78.8 score on a scaleStandard Deviation 11.6
Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)

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.

Time frame: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred

Population: One patient was withdrawn from the study prior to the 8 week follow-up visit due to an adverse event. Therefore, only 9 patients were included in the analysis at 8 weeks and 12 weeks postoperative.

ArmMeasureGroupValue (MEAN)Dispersion
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)Preoperative41.1 score on a scaleStandard Deviation 12.7
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)Homecare Visit 136.3 score on a scaleStandard Deviation 17.1
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)Homecare Visit 256.0 score on a scaleStandard Deviation 18
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)Homecare Visit 362.8 score on a scaleStandard Deviation 13.5
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)4 Weeks Postoperative73.0 score on a scaleStandard Deviation 16.5
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)8 Weeks Postoperative72.6 score on a scaleStandard Deviation 16.2
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form)12 Weeks Postoperative78.1 score on a scaleStandard Deviation 15.3
Secondary

Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL

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.

Time frame: Once preoperatively then postoperatively once weekly from the date of discharge until the 12 week follow-up appointment has occurred

Population: One patient was withdrawn from the study prior to the 8 week follow-up visit due to an adverse event. Therefore, only 9 patients were included in the analysis at 8 weeks and 12 weeks postoperative.

ArmMeasureGroupValue (MEAN)Dispersion
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOLHomecare Visit 343.8 score on a scaleStandard Deviation 15.9
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOLPreoperative25.1 score on a scaleStandard Deviation 8.8
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOLHomecare Visit 125.0 score on a scaleStandard Deviation 15.3
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOLHomecare Visit 236.1 score on a scaleStandard Deviation 12.8
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL4 Weeks Postoperative50.0 score on a scaleStandard Deviation 19
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL8 Weeks Postoperative52.1 score on a scaleStandard Deviation 14
Home-based MonitoringKnee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL12 Weeks Postoperative57.8 score on a scaleStandard Deviation 9.3
Secondary

Rehab Compliance

Percentage of required at-home therapy exercises completed each session, as well as the total percentage completed during all home therapy sessions

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

ArmMeasureGroupValue (MEAN)Dispersion
Home-based MonitoringRehab ComplianceHomecare Visit 288 percentage of exercises completedStandard Deviation 11
Home-based MonitoringRehab ComplianceHomecare Visit 394 percentage of exercises completedStandard Deviation 7
Home-based MonitoringRehab Compliance4 Weeks Postop94 percentage of exercises completedStandard Deviation 13
Secondary

Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)

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.

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

Population: One patient was withdrawn from the study prior to the 8 week follow-up visit due to an adverse event. Therefore, only 9 patients were included in the analysis at 8 weeks and 12 weeks postoperative.

ArmMeasureGroupValue (MEAN)Dispersion
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)Preoperative4 score on a scaleStandard Deviation 3
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)Homecare Visit 14 score on a scaleStandard Deviation 4
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)Homecare Visit 24 score on a scaleStandard Deviation 2
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)Homecare Visit 34 score on a scaleStandard Deviation 2
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)4 Weeks Postoperative4 score on a scaleStandard Deviation 2
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)8 Weeks Postoperative2 score on a scaleStandard Deviation 2
Home-based MonitoringVisual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period)12 Weeks Postoperative1 score on a scaleStandard Deviation 1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026