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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03737149
Registration number
NCT03737149
Ethics application status
Date submitted
26/10/2018
Date registered
9/11/2018
Titles & IDs
Public title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
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Scientific title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
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Secondary ID [1]
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CLU2018-13CH
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
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Osteoarthritis, Hip
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - mymobility with Apple Watch
Experimental: mymobility with Apple Watch - Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
No intervention: Standard of Care Physical Therapy - Standard of care patient education and post-operative physical therapy, as determined by local site guidelines and care pathways.
Other interventions: mymobility with Apple Watch
The mymobility mobile application is a mobile software platform designed to facilitate remote episode of care management and asynchronous communication between the provider care team and their patient via provider-approved care plans and engagement communications. Current care pathways have been developed for: Total Hip Replacement, Total Knee Replacement and Partial Knee Replacement. Designed for the orthopedic population, mymobility also integrates wearable data from the Apple Watch into provider dashboards, providing enhanced understanding and monitoring of patients throughout the episode of care.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase II (RCT): Readmission Rate
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Assessment method [1]
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RCT Phase: Non-inferiority of the mymobility with Apple Watch group in the number of readmissions through 30 days post-op compared to subjects receiving standard physical therapy.
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Timepoint [1]
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30 Days postop
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Secondary outcome [1]
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Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR)
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Assessment method [1]
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The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
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Timepoint [1]
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90 Days
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Secondary outcome [2]
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Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR)
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Assessment method [2]
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The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
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Timepoint [2]
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90 Days
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Secondary outcome [3]
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Phase II RCT: EQ-5D-5L
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Assessment method [3]
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Non-inferiority in post-operative EQ-5D-5L outcomes for the mymobility with Apple Watch group compared to subjects receiving standard physical therapy.
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Timepoint [3]
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90 Days
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Secondary outcome [4]
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Phase II RCT: Incidence of Manipulation under Anesthesia (MUA)
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Assessment method [4]
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Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
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Timepoint [4]
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90 Days
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Secondary outcome [5]
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Phase II RCT: Timed Up and Go (TUG)
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Assessment method [5]
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Timed Up and Go Test: The time to rise from a chair, walk 10 feet, turn around, walk back to the chair and sit down.
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Timepoint [5]
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90 Days
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Secondary outcome [6]
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Phase II RCT: Single-Leg Stance (SLS) Test
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Assessment method [6]
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Balance Test while standing on a single leg. Three tests are performed and the best of the three times is recorded. The maximum time for this test is 60 seconds.
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Timepoint [6]
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90 Days
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Secondary outcome [7]
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Phase II RCT: Subject Satisfaction
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Assessment method [7]
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Comparison of subject satisfaction survey results between the study groups.
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Timepoint [7]
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90 Days
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Secondary outcome [8]
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Phase II RCT: Healthcare Costs
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Assessment method [8]
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The number of hospital readmissions, reoperations, urgent care visits, and emergency room visits will be captured and used to calculate the cost of care after the joint replacement procedure.
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Timepoint [8]
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90 Days
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. Subject must be 18 years of age or older.
2. Subject qualifies for a primary, unilateral total or partial knee arthroplasty, based on physical exam and medical history.
3. Investigator plans to treat subject with a commercially-available device, used on-label according to the manufacturer's instructions for use, as part of their clinical care.
4. Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App.
5. Subject is willing and able to complete the protocol required follow-up.
6. Subject is able to read and understand the language used in the mymobility App for their region.
7. Subject is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB/EC approved Informed Consent Form and Authorization. Where applicable, subject must also be willing to provide authorization for use of protected health information in accordance with local privacy laws.
8. Subject is mobile with no more than a single cane/single crutch assist preoperatively.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Subject is a current alcohol or drug abuser as defined by the investigator.
2. Subject is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
3. Subject has systemic inflammatory arthropathies which would interfere or compromise the activity profiles within this study.
4. Subject is currently participating in any other surgical intervention, physical therapy or pain management study which would compromise the results of this study.
5. Subject requires simultaneous or staged bilateral replacements, staged<90 days apart. Subjects can be enrolled into the study for the second, staged arthroplasty if scheduled >89 days after their first, contralateral replacement.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2025
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Actual
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Sample size
Target
10500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,VIC
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Recruitment hospital [1]
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National Capital Private Hospital - Canberra
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Recruitment hospital [2]
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Epworth Healthcare - Richmond - Richmond
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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3121 - Richmond
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Michigan
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Missouri
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New Jersey
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New Mexico
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Utah
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Italy
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Roma
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Country [20]
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Netherlands
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State/province [20]
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Geldrop
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Zimmer Biomet
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Post-market prospective, multi-center longitudinal study to determine if mobile application-guided education and exercise paired with accurate and sensitive activity monitoring, captured from consumer wearables, can provide a viable (and potentially improved) alternative to current standard of care physical therapy for hip and knee arthroplasty.
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Trial website
https://clinicaltrials.gov/study/NCT03737149
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Erin Osborn
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Address
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Zimmer Biomet
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03737149