Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03737149
Registration number
NCT03737149
Ethics application status
Date submitted
26/10/2018
Date registered
9/11/2018
Date last updated
7/06/2024
Titles & IDs
Public title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Query!
Scientific title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Query!
Secondary ID [1]
0
0
CLU2018-13CH
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee
0
0
Query!
Osteoarthritis, Hip
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Phase II (RCT): Readmission Rate
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
30 Days postop
Query!
Secondary outcome [1]
0
0
Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR)
Query!
Assessment method [1]
0
0
The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Query!
Timepoint [1]
0
0
90 Days
Query!
Secondary outcome [2]
0
0
Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR)
Query!
Assessment method [2]
0
0
The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Query!
Timepoint [2]
0
0
90 Days
Query!
Secondary outcome [3]
0
0
Phase II RCT: EQ-5D-5L
Query!
Assessment method [3]
0
0
Non-inferiority in post-operative EQ-5D-5L outcomes for the mymobility with Apple Watch group compared to subjects receiving standard physical therapy.
Query!
Timepoint [3]
0
0
90 Days
Query!
Secondary outcome [4]
0
0
Phase II RCT: Incidence of Manipulation under Anesthesia (MUA)
Query!
Assessment method [4]
0
0
Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
Query!
Timepoint [4]
0
0
90 Days
Query!
Secondary outcome [5]
0
0
Phase II RCT: Timed Up and Go (TUG)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
90 Days
Query!
Secondary outcome [6]
0
0
Phase II RCT: Single-Leg Stance (SLS) Test
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
90 Days
Query!
Secondary outcome [7]
0
0
Phase II RCT: Subject Satisfaction
Query!
Assessment method [7]
0
0
Comparison of subject satisfaction survey results between the study groups.
Query!
Timepoint [7]
0
0
90 Days
Query!
Secondary outcome [8]
0
0
Phase II RCT: Healthcare Costs
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
90 Days
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Supportive Care
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
22/10/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/07/2025
Query!
Actual
Query!
Sample size
Target
10500
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Query!
Recruitment hospital [1]
0
0
National Capital Private Hospital - Canberra
Query!
Recruitment hospital [2]
0
0
Epworth Healthcare - Richmond - Richmond
Query!
Recruitment postcode(s) [1]
0
0
2605 - Canberra
Query!
Recruitment postcode(s) [2]
0
0
3121 - Richmond
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Georgia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Michigan
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New Mexico
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Oregon
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Pennsylvania
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Utah
Query!
Country [19]
0
0
Italy
Query!
State/province [19]
0
0
Roma
Query!
Country [20]
0
0
Netherlands
Query!
State/province [20]
0
0
Geldrop
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Zimmer Biomet
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03737149
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Erin Osborn
Query!
Address
0
0
Zimmer Biomet
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03737149
Download to PDF