A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
|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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03737149|
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : August 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Osteoarthritis, Hip||Other: mymobility with Apple Watch||Not Applicable|
This is a post-market prospective, multi-center longitudinal study in subjects undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA), or partial knee arthroplasty (PKA). The study objective is 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 patient education and physical therapy for hip and knee arthroplasty. The study will be conducted in phases. The first phase (N = 300) will consist of a pilot cohort of subjects and will primarily serve to determine site study staffing needs and time required for various elements of study execution. The second phase (N = 1,000, RCT) will consist of a randomized controlled subject cohort and will compare outcomes of mobile application-guided exercises and activity with standard of care (SOC) physical therapy. The third phase (N ~ 10,000 including subjects from both Phase I and the study arm from RCT/Phase II) will seek to collect enough data to enable the creation of decision support algorithms for outcomes of joint replacement. All subjects will undergo a TKA, THA, or PKA using SOC procedures and commercially-available devices as part of their clinical care. Subjects will then complete prescribed post-operative activities, such as physical therapy, according to SOC or performing exercises as scheduled through the mymobility app. In office assessments will be conducted at approximately 30 days prior to surgery, 30 days after surgery, and 3 months after surgery. Virtual assessments (including subject questionnaires and recording of adverse events) will occur at approximately 6 months and 1 year post-op.
February 2022 update: Eligibility criteria for new patients includes total knee and partial knee arthroplasty surgeries. Previously enrolled total hip arthroplasty patients will remain in the study for follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10500 participants|
|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|
Experimental: mymobility with Apple Watch
Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
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.
- 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.
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, CCRPfirstname.lastname@example.org|
|Study Director:||Erin Osborn||Zimmer Biomet|