Clinical trial NCT05091918: Limited Market Release - MotionSense Clinical Use Evaluation
Official title: FS5 Limited Market Release - MotionSense Clinical Use Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Patient Engagement
Patient-Reported Outcome Measures (PROMs)
Keywords: MotionSense
Lead sponsor: Orthosensor, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 101
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office
timeFrame: 30 days preoperative to 90 days postoperative
measure: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery
timeFrame: 30 days preoperative to 90 days postoperative
measure: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires
timeFrame: Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative
measure: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program
timeFrame: 30 days preoperative to 90 days postoperative
measure: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic
timeFrame: Preoperative onboarding visit
measure: Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists
timeFrame: Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative
Secondary outcomes:
measure: Correlate Functional and Patient Reported Outcome Metrics
timeFrame: 2 weeks, 6 weeks, 90 days postoperative
measure: Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)
timeFrame: 30 days preoperative to 90 days postoperative
measure: Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used
timeFrame: 30 days preoperative to 90 days postoperative
measure: Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office
timeFrame: 30 days preoperative to 90 days postoperative
measure: Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores
timeFrame: 30 days preoperative to 90 days postoperative
measure: Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps
timeFrame: 30 days preoperative to 90 days postoperative
measure: Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Knee Active and Weight Bearing Time
timeFrame: 30 days preoperative to 90 days postoperative
measure: Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion
timeFrame: 30 days preoperative to 90 days postoperative
measure: Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Gait Quality (Steps Per Minute)
timeFrame: 30 days preoperative to 90 days postoperative
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Joint Reconstruction Institute
state: Oklahoma
city: Wakefield
country: United States
facility: Robotic Joint Replacement Institute LLC
state: Rhode Island
Study officials:
References: