Knee ArthroplastyFS5NCT05091918

Limited Market Release - MotionSense Clinical Use Evaluation

A study testing MotionSense in people with Knee Arthroplasty and Patient Engagement, run by Orthosensor, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
What is being tested?: MotionSense
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 2 sitesUnited States
Study dates: 27 May 2021to 1 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Planned for unilateral total knee surgery in the coming 4 weeks
Age 50 to 80
Owns a smart phone

Who cannot join

BMI exceeding 35
Severe skin conditions

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
Being tested: MotionSense
Keywords: MotionSense
Medical subject headings: Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MotionSenseDevice
MotionSense Wearable: Remote patient monitoring

Study groups in NCT05091918
Study group	Role	What they receive
MotionSense Wearable	Other	Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA Receives: Device: MotionSense

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative

Secondary outcomes (9)

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 30 days preoperative to 90 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 May 20211 Aug 2022

First posted25 Oct 2021
Study start27 May 2021
Primary completion1 Aug 2022
Study completion1 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05091918
Sponsor's protocol ID: Orthosensor
Acronym: FS5
Status last verified: Jun 2024
First submitted: 13 Oct 2021
Last updated: 10 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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All Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: FS5 Limited Market Release - MotionSense Clinical Use Evaluation
ClinicalTrials.gov ID: NCT05091918
Acronym / sponsor ID: FS5 / Orthosensor
Conditions: Knee Arthroplasty, Patient Engagement, Patient-Reported Outcome Measures (PROMs)
Keywords: MotionSense
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Orthosensor, Inc.Industry (pharma, biotech, devices)
Study start: 27 May 2021 (actual)
Primary completion: 1 Aug 2022 (actual)
Study completion: 1 Aug 2022 (actual)
First posted: 25 Oct 2021 (actual)
Results: Posted 7 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MotionSense Wearable	Other	Device: MotionSenseUsing MotionSense from pre-op to 90 days post-op during the recovery after primary TKA

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Planned for unilateral total knee surgery in the coming 4 weeks
Age 50 to 80
Owns a smart phone

Key exclusion criteria (2 listed)

BMI exceeding 35
Severe skin conditions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MotionSenseMotionSense Wearable: Remote patient monitoring	Device	MotionSense Wearable

Primary outcome

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office
Time frame: 30 days preoperative to 90 days postoperative
Hours spent per day in office by practice using MotionSense wearable system, from 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
Time frame: 30 days preoperative to 90 days postoperative
Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires
Time frame: 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.
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program
Time frame: 30 days preoperative to 90 days postoperative
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.
Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic
Time frame: Preoperative onboarding visit
Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.
Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists
Time frame: 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

9 secondary outcomes

Correlate Functional and Patient Reported Outcome Metrics
Time frame: 2 weeks, 6 weeks, 90 days postoperative
Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)
Time frame: 30 days preoperative to 90 days postoperative
Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used
Time frame: 30 days preoperative to 90 days postoperative
Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office
Time frame: 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
Time frame: 30 days preoperative to 90 days postoperative
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily Steps
Time frame: 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
Time frame: 30 days preoperative to 90 days postoperative
Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Range of Motion
Time frame: 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)
Time frame: 30 days preoperative to 90 days postoperative

Results and safety

Results posted to the registry on 7 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motionsense Wearable Group	101	19

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

Time frame: 30 days preoperative to 90 days postoperative

Population analysed: The office staff did not collect data on the hours spent per day in office, except for onboarding time, which is Outcome Measure 5.

Primary outcome: Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery

Time frame: 30 days preoperative to 90 days postoperative. Median (Inter-Quartile Range). Unit: Days relative to surgery

Measure	MotionSense Wearable Group n = 101
Preoperative day of initial use	-12 (-14 to -7)
Preoperative day of last use	-1 (-4 to -1)
Postoperative day of initial use	2 (1 to 5)
Postoperative day of last use	68 (36 to 89)

Population analysed: Preoperative participants: 2 Patients did not wear device preoperatively. Postoperative participants: 23 Patients did not wear device postoperatively.

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

Time frame: Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative. Count of participants. Unit: Participants

Measure	MotionSense Wearable Group n = 101
Preoperative questionnaire	87
Postoperative 2 week questionnaire	58
Postoperative 6 week questionnaire	50
Postoperative 90 day questionnaire	15

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

Time frame: 30 days preoperative to 90 days postoperative. Median (Inter-Quartile Range). Unit: Percent of completed exercise sessions

Measure	MotionSense Wearable Group n = 91
Value	19 (6 to 40)

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

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days pre-op until 90 days post-op. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motionsense Wearable Group	2 of 101 (2%)	10 of 101 (9.9%)	0 of 101

Limitations and caveats (from the sponsor): Comment for Document Section: Initially the Ethical Review Committee did not request a detailed Statistical Analysis Plan. The Statistical Analysis Plan was uploaded to describe the standard analysis for descriptive statics. The study concluded on August 1, 2022. Therefore, belated IRB approval of the standard statistical analysis plan was not requested.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Arthroplasty

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
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Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MotionSense in people with Knee Arthroplasty and Patient Engagement, run by Orthosensor, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office (time frame: 30 days preoperative to 90 days postoperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05091918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.