N/A N=101 Diagnostic

Limited Market Release - MotionSense Clinical Use Evaluation

Knee Arthroplasty · Patient Engagement · Patient-Reported Outcome Measures (PROMs)

Bottom Line

View on ClinicalTrials.gov: NCT05091918 ↗

Enrolled (actual)

101

Serious AEs

2.0%

Results posted

Sep 2023

Primary outcome: Primary: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MotionSense (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Orthosensor, Inc.
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office	—	—
PRIMARY Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery	-12; -1; 2; 68	—
PRIMARY Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires	87; 58; 50; 15	—
PRIMARY Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program	19	—
PRIMARY Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic	32	—
PRIMARY Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists	22; 0; 22; 21; 0; 0	—
SECONDARY Correlate Functional and Patient Reported Outcome Metrics	0.24; 0.21; -0.01; 0.07; 0.21; 0.17	—
SECONDARY Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)	—	—
SECONDARY Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used	—	—
SECONDARY Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office	7	—
SECONDARY Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores	3	—
SECONDARY Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps	2519	—
SECONDARY Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time	142; 60	—
SECONDARY Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion	110	—
SECONDARY Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)	47	—

Summary

Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05091918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.