Limited Market Release - MotionSense Clinical Use Evaluation (FS5)

FS5 Limited Market Release - MotionSense Clinical Use Evaluation

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

Study Overview

• Status: Completed
• Conditions: Patient Engagement; Knee Arthroplasty; Patient-Reported Outcome Measures (PROMs)
• Intervention / Treatment: Device: MotionSense

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • Oklahoma Joint Reconstruction Institute
  • Rhode Island
    • Wakefield, Rhode Island, United States, 02879
      • Robotic Joint Replacement Institute LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MotionSense Wearable; Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA	Device: MotionSense; MotionSense Wearable: Remote patient monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative	30 days preoperative to 90 days postoperative
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.	Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative
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.	30 days preoperative to 90 days postoperative
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.	Preoperative onboarding visit
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	Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks, 6 weeks, 90 days postoperative
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.	30 days preoperative to 90 days postoperative
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.	30 days preoperative to 90 days postoperative
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	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	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.	30 days preoperative to 90 days postoperative
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	30 days preoperative to 90 days postoperative
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.	30 days preoperative to 90 days postoperative
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.	30 days preoperative to 90 days postoperative
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	30 days preoperative to 90 days postoperative

Collaborators and Investigators

• Sponsor: Orthosensor, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MotionSense
• Other Study ID Numbers: Orthosensor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No