Trial Outcomes & Findings for Limited Market Release - MotionSense Clinical Use Evaluation (NCT NCT05091918)

NCT ID: NCT05091918

Last Updated: 2024-07-10

Results Overview

Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: 30 days preoperative to 90 days postoperative
• Results posted on: 2024-07-10

Participant Flow

Participant milestones

Measure	Motionsense Wearable Group Using Motionsense from pre-op to 90 days post-op during the recovery after primary TKA Motionsense Wearable: Remote patient monitoring
Overall Study STARTED	101
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	82

Reasons for withdrawal

Measure	Motionsense Wearable Group Using Motionsense from pre-op to 90 days post-op during the recovery after primary TKA Motionsense Wearable: Remote patient monitoring
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	81

Baseline Characteristics

Limited Market Release - MotionSense Clinical Use Evaluation

Baseline characteristics by cohort

Measure	Motionsense Wearable Group n=101 Participants 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
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	3 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	80 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Other/Multiple	3 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Declined to respond	14 Participants n=5 Participants
Region of Enrollment United States	101 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative

Outcome measures

Measure	MotionSense Wearable Group n=101 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
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 Interval -14.0 to -7.0
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 Interval -4.0 to -1.0
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 Interval 1.0 to 5.0
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 Interval 36.0 to 89.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	MotionSense Wearable Group n=101 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires Preoperative questionnaire	87 Participants
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires Postoperative 2 week questionnaire	58 Participants
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires Postoperative 6 week questionnaire	50 Participants
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires Postoperative 90 day questionnaire	15 Participants

PRIMARY outcome

Timeframe: 30 days preoperative to 90 days postoperative

Population: There were 10 patients who did not have any exercise data that was completed.

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.

Outcome measures

Measure	MotionSense Wearable Group n=91 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program	19 Percent of completed exercise sessions Interval 6.0 to 40.0

PRIMARY outcome

Timeframe: Preoperative onboarding visit

Population: There were 7 patients who did not have onboarding time data collected.

Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.

Outcome measures

Measure	MotionSense Wearable Group n=94 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic	32 Minutes Interval 25.0 to 42.0

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	MotionSense Wearable Group n=101 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
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 Interval 5.0 to 68.0
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 Interval 0.0 to 0.0
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 Interval 5.0 to 68.0
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 Interval 4.0 to 67.0
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 Interval 0.0 to 0.0
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 Interval 0.0 to 0.0
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 Interval 1.0 to 2.0
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 Interval 0.0 to 0.0
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 Interval 5.0 to 68.0
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 Interval 0.0 to 0.0
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 Interval 1.0 to 1.0
Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists Pre-op: Warmup	22 Percent of participants assigned Interval 5.0 to 68.0
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 Interval 85.0 to 91.0
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 Interval 0.0 to 9.0
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 Interval 82.0 to 91.0
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 Interval 85.0 to 90.0
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 Interval 0.0 to 0.0
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 Interval 5.0 to 20.0
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 Interval 6.0 to 20.0
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 Interval 3.0 to 18.0
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 Interval 82.0 to 91.0
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 Interval 4.0 to 13.0
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 Interval 3.0 to 7.0
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 Interval 83.0 to 91.0
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 Interval 61.0 to 70.0
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 Interval 20.0 to 26.0
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 Interval 62.0 to 70.0
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 Interval 69.0 to 74.0
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 Interval 7.0 to 14.0
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 Interval 26.0 to 28.0
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 Interval 29.0 to 31.0
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 Interval 26.0 to 28.0
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 Interval 63.0 to 70.0
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 Interval 19.0 to 22.0
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 Interval 14.0 to 16.0
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 Interval 72.0 to 75.0
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 Interval 53.0 to 57.0
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 Interval 29.0 to 30.0
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 Interval 54.0 to 58.0
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 Interval 62.0 to 65.0
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 Interval 16.0 to 17.0
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 Interval 28.0 to 30.0
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 Interval 28.0 to 30.0
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 Interval 26.0 to 27.0
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 Interval 55.0 to 58.0
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 Interval 21.0 to 21.0
Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists Assisted knee stretches	16 Percent of participants assigned Interval 16.0 to 16.0
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 Interval 65.0 to 67.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MotionSense Wearable Group n=101 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Correlate Functional and Patient Reported Outcome Metrics KOOS: ADL, 2 weeks	0.24 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: ADL, 6 weeks	0.21 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: ADL, 90 days	-0.01 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Pain, 2 weeks	0.07 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Pain, 6 weeks	0.21 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Pain, 90 days	0.17 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: QoL, 2 weeks	0.16 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: QoL, 6 weeks	0.11 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: QoL, 90 days	0.09 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Sport/Recreation, 2 weeks	0.08 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Sport/Recreation, 6 weeks	0.01 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Sport/Recreation, 90 days	0.16 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Symptoms, 2 weeks	0.12 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Symptoms, 6 weeks	-0.02 Spearman Correlation Coefficient
Correlate Functional and Patient Reported Outcome Metrics KOOS: Symptoms, 90 days	-0.23 Spearman Correlation Coefficient

SECONDARY outcome

Timeframe: 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.

Number of leg registrations performed (per day) per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Number of weekly and daily patches used per patient, while wearing MotionSense from 30 days preoperative to 90 days postoperative.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MotionSense Wearable Group n=101 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office	7 Shared pictures Interval 0.0 to 17.0

SECONDARY outcome

Timeframe: 30 days preoperative to 90 days postoperative

Population: 4 patients were not included in the analysis because they did not produce 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.

Outcome measures

Measure	MotionSense Wearable Group n=97 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores	3 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Daily steps while wearing MotionSense from 30 days preoperative to 90 days postoperative

Outcome measures

Measure	MotionSense Wearable Group n=97 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps	2519 Daily steps Interval 886.0 to 4771.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MotionSense Wearable Group n=101 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
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 Interval 32.0 to 94.0
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 Interval 82.0 to 214.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	MotionSense Wearable Group n=89 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion	110 Degrees Interval 100.0 to 120.0

SECONDARY outcome

Timeframe: 30 days preoperative to 90 days postoperative

Population: Gait analysis was incomplete for 16 patients.

Steps per minute while wearing MotionSense from 30 days preoperative to 90 days postoperative

Outcome measures

Measure	MotionSense Wearable Group n=85 Participants Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)	47 Steps per minute Interval 42.0 to 52.0

Adverse Events

Motionsense Wearable Group

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Motionsense Wearable Group n=101 participants at risk 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
Infections and infestations Deep joint infection	0.99% 1/101 • 30 days pre-op until 90 days post-op
Musculoskeletal and connective tissue disorders Knee stiffness Arthrofibrosis	0.99% 1/101 • 30 days pre-op until 90 days post-op

Other adverse events

Measure	Motionsense Wearable Group n=101 participants at risk 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
Skin and subcutaneous tissue disorders Skin reaction	9.9% 10/101 • 30 days pre-op until 90 days post-op

Additional Information

Kevin Barga

Stryker

Phone: +12018315073

Email: Kevin.Barga@stryker.com

Results disclosure agreements

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