A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
- Conditions
- Osteoarthritis, KneeOsteoarthritis, Hip
- Interventions
- Other: mymobility with Apple Watch
- Registration Number
- NCT03737149
- Lead Sponsor
- Zimmer Biomet
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mymobility with Apple Watch mymobility with Apple Watch Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
- Primary Outcome Measures
Name Time Method Phase II (RCT): Readmission Rate 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.
- Secondary Outcome Measures
Name Time Method Phase II RCT: Healthcare Costs 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.
Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR) 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: EQ-5D-5L 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) 90 Days Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR) 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: Single-Leg Stance (SLS) Test 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 90 Days Comparison of subject satisfaction survey results between the study groups.
Phase II RCT: Timed Up and Go (TUG) 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.
Trial Locations
- Locations (29)
Sah Orthopaedic Associates
🇺🇸Fremont, California, United States
Hoag Orthopedic Institute
🇺🇸Irvine, California, United States
Stanford University
🇺🇸Redwood City, California, United States
Colorado Joint Replacement
🇺🇸Denver, Colorado, United States
Panorama Orthopedics & Spine Center
🇺🇸Golden, Colorado, United States
Foundation for Orthopedic Research and Education
🇺🇸Temple Terrace, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Midwest Center for Joint Replacement
🇺🇸Indianapolis, Indiana, United States
Bluegrass Orthopaedics
🇺🇸Lexington, Kentucky, United States
OrthoBethesda
🇺🇸Bethesda, Maryland, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States
Ascension Medical Group - University Orthopaedic Specialists
🇺🇸Rochester Hills, Michigan, United States
Michigan Orthopaedic Surgeons
🇺🇸Troy, Michigan, United States
Washington University
🇺🇸St Louis, Missouri, United States
Rothman Institute
🇺🇸Bryn Mawr, Pennsylvania, United States
New Mexico Orthopaedic Associates
🇺🇸Alburquerque, New Mexico, United States
Duke University
🇺🇸Morrisville, North Carolina, United States
Cleveland Clinic Main Campus
🇺🇸Cleveland, Ohio, United States
JIS Orthopedics
🇺🇸New Albany, Ohio, United States
Orthopedic + Fracture Specialists
🇺🇸Portland, Oregon, United States
ROC Orthopedics
🇺🇸Tualatin, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
National Capital Private Hospital
🇦🇺Canberra, Australian Capital Territory, Australia
Epworth Healthcare - Richmond
🇦🇺Richmond, Victoria, Australia
Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Italy
St. Annaziekenhuis
🇳🇱Geldrop, Netherlands