Trial Outcomes & Findings for Home Monitoring After Primary Total Knee Arthroplasty (NCT NCT03032068)

NCT ID: NCT03032068

Last Updated: 2022-01-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: daily, from the date of discharge until the 12 week postoperative follow-up appointment has occurred
• Results posted on: 2022-01-18

Participant Flow

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

All participants were enrolled in the same group.

Participant milestones

Measure	Home-based Monitoring All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Overall Study STARTED	10
Overall Study Preoperative Visit	10
Overall Study Postoperative Home Care Visit 1	10
Overall Study Postoperative Home Care Visit 2	10
Overall Study Postoperative Home Care Visit 3	10
Overall Study 4 Weeks Postoperative Visit	9
Overall Study 8 Weeks Postoperative Visit	9
Overall Study 12 Weeks Postoperative Visit	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Home-based Monitoring All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Overall Study Adverse Event	1

Baseline Characteristics

Home Monitoring After Primary Total Knee Arthroplasty

Baseline characteristics by cohort

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Age, Continuous	67 years n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants

PRIMARY outcome

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

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.

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
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.	91 percentage of received vs expected data Standard Deviation 6

SECONDARY outcome

Timeframe: Percentage of exercises completed 2-3 times daily, from the date of discharge up to approximately 4 weeks postoperatively when outpatient physical therapy begins

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

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Rehab Compliance Homecare Visit 2	88 percentage of exercises completed Standard Deviation 11
Rehab Compliance Homecare Visit 3	94 percentage of exercises completed Standard Deviation 7
Rehab Compliance 4 Weeks Postop	94 percentage of exercises completed Standard Deviation 13

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Change From Preoperative to Postoperative Knee Range of Motion Preoperative	17 degrees Interval 4.2 to 29.8
Change From Preoperative to Postoperative Knee Range of Motion Homecare Visit 1	5.8 degrees Interval -18.5 to 30.2
Change From Preoperative to Postoperative Knee Range of Motion Homecare Visit 2	9.7 degrees Interval -8.6 to 28.0
Change From Preoperative to Postoperative Knee Range of Motion Homecare Visit 3	2.2 degrees Interval -42.3 to 46.7
Change From Preoperative to Postoperative Knee Range of Motion 4 Weeks Postoperative	-1.1 degrees Interval -31.0 to 28.8
Change From Preoperative to Postoperative Knee Range of Motion 8 Weeks Postoperative	13.3 degrees Interval -14.7 to 41.3
Change From Preoperative to Postoperative Knee Range of Motion 12 Weeks Postoperative	22.3 degrees Interval 11.3 to 33.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Change From Preoperative to Postoperative Timed Up and Go Test Preoperative	0.1 seconds difference Interval -0.1 to 0.3
Change From Preoperative to Postoperative Timed Up and Go Test Homecare Visit 1	0.1 seconds difference Interval -0.8 to 1.1
Change From Preoperative to Postoperative Timed Up and Go Test Homecare Visit 2	0.3 seconds difference Interval -0.3 to 0.8
Change From Preoperative to Postoperative Timed Up and Go Test Homecare Visit 3	0.0 seconds difference Interval -0.9 to 0.9
Change From Preoperative to Postoperative Timed Up and Go Test 4 Weeks Postoperative	-0.3 seconds difference Interval -1.2 to 0.7
Change From Preoperative to Postoperative Timed Up and Go Test 8 Weeks Postoperative	0.6 seconds difference Interval 0.1 to 1.2
Change From Preoperative to Postoperative Timed Up and Go Test 12 Weeks Postoperative	0.2 seconds difference Interval -0.1 to 0.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) Preoperative	4 score on a scale Standard Deviation 3
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) Homecare Visit 1	4 score on a scale Standard Deviation 4
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) Homecare Visit 2	4 score on a scale Standard Deviation 2
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) Homecare Visit 3	4 score on a scale Standard Deviation 2
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) 4 Weeks Postoperative	4 score on a scale Standard Deviation 2
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) 8 Weeks Postoperative	2 score on a scale Standard Deviation 2
Visual Analog Scale for Pain (Knee-related Pain at Its Worst Over a 24 Hour Period) 12 Weeks Postoperative	1 score on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain Preoperative	41.7 score on a scale Standard Deviation 7.8
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain Homecare Visit 1	41.2 score on a scale Standard Deviation 10.0
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain Homecare Visit 2	54.6 score on a scale Standard Deviation 17.2
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain Homecare Visit 3	70.0 score on a scale Standard Deviation 5.0
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain 4 Weeks Postoperative	68.5 score on a scale Standard Deviation 16.3
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain 8 Weeks Postoperative	73.7 score on a scale Standard Deviation 15.3
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS Pain 12 Weeks Postoperative	78.8 score on a scale Standard Deviation 11.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) Preoperative	41.1 score on a scale Standard Deviation 12.7
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) Homecare Visit 1	36.3 score on a scale Standard Deviation 17.1
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) Homecare Visit 2	56.0 score on a scale Standard Deviation 18.0
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) Homecare Visit 3	62.8 score on a scale Standard Deviation 13.5
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) 4 Weeks Postoperative	73.0 score on a scale Standard Deviation 16.5
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) 8 Weeks Postoperative	72.6 score on a scale Standard Deviation 16.2
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS PS (Physical Function Short Form) 12 Weeks Postoperative	78.1 score on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Home-based Monitoring n=10 Participants All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL Preoperative	25.1 score on a scale Standard Deviation 8.8
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL Homecare Visit 1	25.0 score on a scale Standard Deviation 15.3
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL Homecare Visit 2	36.1 score on a scale Standard Deviation 12.8
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL Homecare Visit 3	43.8 score on a scale Standard Deviation 15.9
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL 4 Weeks Postoperative	50.0 score on a scale Standard Deviation 19.0
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL 8 Weeks Postoperative	52.1 score on a scale Standard Deviation 14.0
Knee Injury and Osteoarthritis Outcome Score (KOOS) - KOOS QOL 12 Weeks Postoperative	57.8 score on a scale Standard Deviation 9.3

Adverse Events

Home-based Monitoring

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Home-based Monitoring n=14 participants at risk All enrolled patients were asked to use technology to collect functional and patient reported outcomes at home after total knee arthroplasty.
Musculoskeletal and connective tissue disorders Quadriceps tendon tear	7.1% 1/14 • Number of events 1 • Adverse event data were collected through 12 weeks postoperatively for each participant. Adverse events were collected routinely at each follow-up visit during the study period

Other adverse events

Adverse event data not reported

Additional Information

Jayson Zadzilka

Cleveland Clinic

Phone: 216-445-8023

Email: zadzilj@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place