A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
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ClinicalTrials.gov Identifier: NCT03737149 |
Recruitment Status :
Recruiting
First Posted : November 9, 2018
Last Update Posted : March 25, 2021
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis, Knee Osteoarthritis, Hip | Other: mymobility with Apple Watch | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | This is a staged cohort study. In the first (pilot) cohort, all participating subjects will utilize the mymobility with Apple Watch platform. In the second (RCT) cohort, approximately 1,000 subjects will be randomized 1:1 to either the mymobility with Apple Watch platform or standard of care SOC. In the third (correlative analytics) cohort, all participating subjects will utilize the mymobility with Apple Watch platform. |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform |
Actual Study Start Date : | October 22, 2018 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Experimental: mymobility with Apple Watch
Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
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Other: 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. |
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.
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- Phase II (RCT): Readmission Rate [ Time Frame: 30 Days postop ]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.
- Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) [ Time Frame: 90 Days ]The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
- Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) [ Time Frame: 90 Days ]The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
- Phase II RCT: EQ-5D-5L [ Time Frame: 90 Days ]Non-inferiority in post-operative EQ-5D-5L outcomes for the mymobility with Apple Watch group compared to subjects receiving standard physical therapy.
- Phase II RCT: Incidence of Manipulation under Anesthesia (MUA) [ Time Frame: 90 Days ]Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
- Phase II RCT: Timed Up and Go (TUG) [ Time Frame: 90 Days ]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.
- Phase II RCT: Single-Leg Stance (SLS) Test [ Time Frame: 90 Days ]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.
- Phase II RCT: Subject Satisfaction [ Time Frame: 90 Days ]Comparison of subject satisfaction survey results between the study groups.
- Phase II RCT: Healthcare Costs [ Time Frame: 90 Days ]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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Subject must be 18 years of age or older.
- Subject qualifies for a primary, unilateral total or partial knee arthroplasty, or total hip arthroplasty based on physical exam and medical history.
- 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.
- Subject owns and maintains an iPhone capable of pairing to the Apple Watch, supporting iOS updates and is compatible with the mymobility App.
- Subject is willing and able to complete the protocol required follow-up.
- Subject is able to read and understand the language used in the mymobility App for their region.
- 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.
- Subject is mobile with no more than a single cane/single crutch assist preoperatively.
Exclusion Criteria
- Subject is a current alcohol or drug abuser as defined by the investigator.
- Subject is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
- Subject has systemic inflammatory arthropathies which would interfere or compromise the activity profiles within this study.
- Subject is currently participating in any other surgical intervention, physical therapy or pain management study which would compromise the results of this study.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737149
Contact: Scott Abshagen, BS, RN, CCRP | 574-371-9782 | scott.abshagen@zimmerbiomet.com | |
Contact: Hillary Overholser | 574-373-2042 | hillary.overholser@zimmerbiomet.com |

Study Director: | Erin Osborn, MBA, CCRP | Zimmer Biomet |
Responsible Party: | Zimmer Biomet |
ClinicalTrials.gov Identifier: | NCT03737149 |
Other Study ID Numbers: |
CLU2018-13CH |
First Posted: | November 9, 2018 Key Record Dates |
Last Update Posted: | March 25, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Knee Replacement Knee Arthroplasty Hip Replacement Hip Arthroplasty Joint Replacement |
Physical Therapy Partial Knee Replacement Hip Pain, Chronic Knee Pain, Chronic |
Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |