CompletedNot Applicable

Limited Market Release - MotionSense Clinical Use Evaluation

United States101 participantsStarted 2021-05-27

Plain-language summary

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

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires

Timeframe: Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program

Timeframe: 30 days preoperative to 90 days postoperative

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic

Timeframe: Preoperative onboarding visit

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

Trial details

NCT IDNCT05091918

SponsorOrthosensor, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-01

Results submitted2023-06-12

View on ClinicalTrials.gov More Knee Arthroplasty trials

Who can participate

Age range

50 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

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

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires

Timeframe: Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program

Timeframe: 30 days preoperative to 90 days postoperative

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic

Timeframe: Preoperative onboarding visit

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