Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
Conditions
Keywords
MotionSense
Brief summary
Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.
Detailed description
During the proposed study, the MotionSense wearable system will be used by patients undergoing total knee arthroplasty (TKA) surgery leading up to and after their surgery. The patients will be using the system to monitor their recovery during daily activities, log daily pain scores and patient reported outcomes while also supporting their prescribed home exercise program. Each patient will thereby participate in outpatient physiotherapy in line with their current standard of care, while the physiotherapist will leverage the opportunities of the presented platform to give the patient personalized reminders for their patient-specific home exercise program. The surgeon / research nurse will additionally be able to monitor the patients recovery remotely as the sensor / app data is shared to the OrthoLogIQ platform.
Interventions
DEVICEMotionSense
MotionSense Wearable: Remote patient monitoring
Sponsors
Orthosensor, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Planned for unilateral total knee surgery in the coming 4 weeks * Age 50 to 80 * Owns a smart phone
Exclusion criteria
* BMI exceeding 35 * Severe skin conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office | 30 days preoperative to 90 days postoperative | Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative. |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | 30 days preoperative to 90 days postoperative | Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative | Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System. |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program | 30 days preoperative to 90 days postoperative | Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative. An exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day. |
| Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic | Preoperative onboarding visit | Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation. |
| Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative | Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods. Isometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat. Heel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time | 30 days preoperative to 90 days postoperative | Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Knee active time is the time the patient spends moving the knee per day. Weight bearing time is the time the patient spends with the leg in an upright position per day. |
| Correlate Functional and Patient Reported Outcome Metrics | 2 weeks, 6 weeks, 90 days postoperative | Spearman correlation of mean step count to Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The Statistical Spearman correlation coefficient evaluates relationships between variables. The Spearman correlation coefficient is used to evaluate the relationship of the mean step count to the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The KOOS consists of 5 subscales: Pain, other symptoms, function in daily living (ADL), function in sport and recreation and knee related quality of life (QOL). The Spearman Correlation coefficients range from -1to 1. If r = 0, there is no linear relationship between the variables. If r=+1, there is a strong direct relationship. If r = -1, there is a strong inverse relationship. |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute) | 30 days preoperative to 90 days postoperative | Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion | 30 days preoperative to 90 days postoperative | Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Range of Motion (ROM) for the knee refers to the degree of movement that can be achieved at the knee joint. It describes the arc or extent of motion from full extension (straightening) to full flexion (bending) in degrees. |
| Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day) | 30 days preoperative to 90 days postoperative | Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative. |
| Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used | 30 days preoperative to 90 days postoperative | Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative. |
| Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office | 30 days preoperative to 90 days postoperative | Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores | 30 days preoperative to 90 days postoperative | Visual Analog Scale (VAS) pain scores while wearing MotionSense from 30 days preoperative to 90 days postoperative The VAS pain score is a patient questionnaire to assess the subjective pain intensity. The VAS is a horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. |
| Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps | 30 days preoperative to 90 days postoperative | Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motionsense Wearable Group Using Motionsense from up to 30 days pre-op and 90 days post-op during the recovery after primary TKA
Motionsense Wearable: Remote patient monitoring | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 81 |
Baseline characteristics
| Characteristic | Motionsense Wearable Group |
|---|---|
| Age, Continuous | 66 years |
| Race/Ethnicity, Customized Ethnicity Declined to respond | 14 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Native | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other/Multiple | 3 Participants |
| Race/Ethnicity, Customized Ethnicity White | 80 Participants |
| Region of Enrollment United States | 101 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 10 / 101 |
| serious Total, serious adverse events | 2 / 101 |
Outcome results
Primary
Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists
Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods. Isometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat. Heel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes
Time frame: Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Isometric quads | 22 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Hamstring curls | 0 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Knee straightening stretches | 22 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Sitting knee bends | 0 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Assisted knee stretches | 1 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Warmup | 22 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Isometric quads | 87 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Sit-to-stands | 2 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Knee straightening | 87 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Assisted knee stretches | 4 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Warm | 87 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Isometric quads | 65 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Sit-to-stands | 24 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Straight-leg raises | 31 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Knee straightening | 65 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Warmup | 73 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Isometric quads | 55 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Long-arc quads | 28 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Straight-leg raises | 29 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Standing knee bends | 27 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Assisted knee stretches | 16 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Warmup | 67 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Sit-to-stands | 0 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Short-arc quads | 22 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Heel slides | 21 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Long-arc quads | 0 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Straight-leg raises | 1 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | Pre-op: Standing knee bends | 0 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Short-arc quads | 85 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Heel slides | 87 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Hamstring curls | 0 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Long-arc quads | 11 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Straight-leg raises | 10 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Standing knee bends | 8 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 0-30 days post-op: Sitting knee bends | 7 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Short-arc quads | 66 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Heel slides | 72 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Hamstring curls | 11 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Long-arc quads | 28 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Standing knee bends | 28 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Sitting knee bends | 22 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 31-60 days post-op: Assisted knee stretches | 16 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Sit-to-stands | 29 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Short-arc quads | 56 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Heel slides | 64 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Hamstring curls | 17 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Knee straightening | 57 Percent of participants assigned |
| MotionSense Wearable Group | Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists | 61-90 days post-op: Sitting knee bends | 21 Percent of participants assigned |
Primary
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires
Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System.
Time frame: Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Preoperative questionnaire | 87 Participants |
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Postoperative 2 week questionnaire | 58 Participants |
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Postoperative 6 week questionnaire | 50 Participants |
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires | Postoperative 90 day questionnaire | 15 Participants |
Primary
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program
Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative. An exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day.
Time frame: 30 days preoperative to 90 days postoperative
Population: There were 10 patients who did not have any exercise data that was completed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program | 19 Percent of completed exercise sessions |
Primary
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office
Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.
Time frame: 30 days preoperative to 90 days postoperative
Population: The office staff did not collect data on the hours spent per day in office, except for onboarding time, which is Outcome Measure 5.
Primary
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery
Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative
Time frame: 30 days preoperative to 90 days postoperative
Population: Preoperative participants: 2 Patients did not wear device preoperatively. Postoperative participants: 23 Patients did not wear device postoperatively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | Preoperative day of initial use | -12 Days relative to surgery |
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | Preoperative day of last use | -1 Days relative to surgery |
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | Postoperative day of initial use | 2 Days relative to surgery |
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery | Postoperative day of last use | 68 Days relative to surgery |
Primary
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic
Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.
Time frame: Preoperative onboarding visit
Population: There were 7 patients who did not have onboarding time data collected.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MotionSense Wearable Group | Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic | 32 Minutes |
Secondary
Correlate Functional and Patient Reported Outcome Metrics
Spearman correlation of mean step count to Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The Statistical Spearman correlation coefficient evaluates relationships between variables. The Spearman correlation coefficient is used to evaluate the relationship of the mean step count to the Knee Injury and Osteoarthritis Outcome Score (KOOS) patient questionnaire. The KOOS consists of 5 subscales: Pain, other symptoms, function in daily living (ADL), function in sport and recreation and knee related quality of life (QOL). The Spearman Correlation coefficients range from -1to 1. If r = 0, there is no linear relationship between the variables. If r=+1, there is a strong direct relationship. If r = -1, there is a strong inverse relationship.
Time frame: 2 weeks, 6 weeks, 90 days postoperative
Population: At 2 weeks (-5 days), 60 patients did not have completed data for KOOS or step count.~At 6 weeks (-5 days), 61 patients did not have completed data for KOOS or step count.~At 90 days (-5 days), 90 patients did not have completed data for KOOS or step count.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: ADL, 2 weeks | 0.24 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: ADL, 6 weeks | 0.21 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: ADL, 90 days | -0.01 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Pain, 2 weeks | 0.07 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Pain, 6 weeks | 0.21 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Pain, 90 days | 0.17 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: QoL, 2 weeks | 0.16 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: QoL, 6 weeks | 0.11 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: QoL, 90 days | 0.09 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Sport/Recreation, 2 weeks | 0.08 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Sport/Recreation, 6 weeks | 0.01 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Sport/Recreation, 90 days | 0.16 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Symptoms, 2 weeks | 0.12 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Symptoms, 6 weeks | -0.02 Spearman Correlation Coefficient |
| MotionSense Wearable Group | Correlate Functional and Patient Reported Outcome Metrics | KOOS: Symptoms, 90 days | -0.23 Spearman Correlation Coefficient |
Secondary
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps
Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative
Time frame: 30 days preoperative to 90 days postoperative
Population: There were 4 patients who did not produce daily steps or wear device for longer than 10 minutes per day.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MotionSense Wearable Group | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps | 2519 Daily steps |
Secondary
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores
Visual Analog Scale (VAS) pain scores while wearing MotionSense from 30 days preoperative to 90 days postoperative The VAS pain score is a patient questionnaire to assess the subjective pain intensity. The VAS is a horizontal line ranging from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.
Time frame: 30 days preoperative to 90 days postoperative
Population: 4 patients were not included in the analysis because they did not produce pain scores.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MotionSense Wearable Group | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores | 3 units on a scale |
Secondary
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)
Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative
Time frame: 30 days preoperative to 90 days postoperative
Population: Gait analysis was incomplete for 16 patients.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MotionSense Wearable Group | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute) | 47 Steps per minute |
Secondary
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time
Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Knee active time is the time the patient spends moving the knee per day. Weight bearing time is the time the patient spends with the leg in an upright position per day.
Time frame: 30 days preoperative to 90 days postoperative
Population: There were 4 patients who did not produce knee active or weight bearing time, or wear the device for greater than 10 minutes per day.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MotionSense Wearable Group | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time | Weight bearing time | 142 minutes |
| MotionSense Wearable Group | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time | Knee active time | 60 minutes |
Secondary
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion
Scores while wearing MotionSense from 30 days preoperative to 90 days postoperative Range of Motion (ROM) for the knee refers to the degree of movement that can be achieved at the knee joint. It describes the arc or extent of motion from full extension (straightening) to full flexion (bending) in degrees.
Time frame: 30 days preoperative to 90 days postoperative
Population: There were 12 patients who did not produce ROM data, wear the device for long enough (\>10 mins/day), or were excluded due to data quality concerns.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MotionSense Wearable Group | Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion | 110 Degrees |
Secondary
Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)
Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.
Time frame: 30 days preoperative to 90 days postoperative
Population: The number of leg registrations performed per day per patient was not collected. These data collections were not technically feasible.
Secondary
Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used
Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.
Time frame: 30 days preoperative to 90 days postoperative
Population: The number of weekly and daily patches used per patient was not collected. Accurate data collection was unattainable by office staff.
Secondary
Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office
Total number of wound pictures shared with surgeon office per patient while wearing MotionSense from 30 days preoperative to 90 days postoperative
Time frame: 30 days preoperative to 90 days postoperative
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MotionSense Wearable Group | Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office | 7 Shared pictures |