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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03737149




Registration number
NCT03737149
Ethics application status
Date submitted
26/10/2018
Date registered
9/11/2018
Date last updated
12/11/2020

Titles & IDs
Public title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Scientific title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Secondary ID [1] 0 0
CLU2018-13CH
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Osteoarthritis, Hip 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase II (RCT): Readmission Rate - 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.
Timepoint [1] 0 0
30 Days postop
Secondary outcome [1] 0 0
Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) - The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Timepoint [1] 0 0
90 Days
Secondary outcome [2] 0 0
Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) - The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Timepoint [2] 0 0
90 Days
Secondary outcome [3] 0 0
Phase II RCT: EQ-5D-5L - Non-inferiority in post-operative EQ-5D-5L outcomes for the mymobility with Apple Watch group compared to subjects receiving standard physical therapy.
Timepoint [3] 0 0
90 Days
Secondary outcome [4] 0 0
Phase II RCT: Incidence of Manipulation under Anesthesia (MUA) - Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
Timepoint [4] 0 0
90 Days
Secondary outcome [5] 0 0
Phase II RCT: Timed Up and Go (TUG) - 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.
Timepoint [5] 0 0
90 Days
Secondary outcome [6] 0 0
Phase II RCT: Single-Leg Stance (SLS) Test - 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.
Timepoint [6] 0 0
90 Days
Secondary outcome [7] 0 0
Phase II RCT: Subject Satisfaction - Comparison of subject satisfaction survey results between the study groups.
Timepoint [7] 0 0
90 Days
Secondary outcome [8] 0 0
Phase II RCT: Healthcare Costs - 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.
Timepoint [8] 0 0
90 Days

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, or
total hip 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,VIC
Recruitment hospital [1] 0 0
National Capital Private Hospital - Canberra
Recruitment hospital [2] 0 0
Epworth Healthcare - Richmond - Richmond
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New Mexico
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Utah
Country [19] 0 0
Netherlands
State/province [19] 0 0
Geldrop

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03737149
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Erin Osborn, MBA, CCRP
Address 0 0
Zimmer Biomet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Scott Abshagen, BS, RN, CCRP
Address 0 0
Country 0 0
Phone 0 0
574-371-9782
Fax 0 0
Email 0 0
scott.abshagen@zimmerbiomet.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03737149