A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

March 20, 2026 updated by: Zimmer Biomet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6559

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • National Capital Private Hospital
    • Victoria
      • Richmond, Victoria, Australia, 3121
        • Epworth HealthCare - Richmond
  • Italy
      • Roma, Italy
        • Policlinico Universitario Campus Bio-Medico
  • Netherlands
      • Geldrop, Netherlands
        • St. Annaziekenhuis
  • United States
    • California
      • Fremont, California, United States, 94538
        • Sah Orthopaedic Associates
      • Irvine, California, United States, 92618
        • Hoag Orthopedic Institute
      • Redwood City, California, United States, 94063
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80210
        • Colorado Joint Replacement
      • Golden, Colorado, United States, 80401
        • Panorama Orthopedics & Spine Center
    • Florida
      • Temple Terrace, Florida, United States, 33637
        • Foundation for Orthopedic Research and Education
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46241
        • Midwest Center for Joint Replacement
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Orthopaedics
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • OrthoBethesda
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Ascension Medical Group - University Orthopaedic Specialists
      • Troy, Michigan, United States, 48084
        • Michigan Orthopaedic Surgeons
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University
    • New Jersey
      • Montvale, New Jersey, United States, 07645
        • Rothman Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • New Mexico Orthopaedic Associates
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus
      • New Albany, Ohio, United States, 43054
        • JIS Orthopedics
    • Oregon
      • Portland, Oregon, United States, 97225
        • Orthopedic + Fracture Specialists
      • Tualatin, Oregon, United States, 97062
        • ROC Orthopedics
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Rothman Institute
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase II (RCT): Readmissions
Time Frame: 30 Days
The number of subjects with a readmission within 30 days after knee or hip replacement surgery.
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 Days
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.
90 Days
Phase II RCT: EQ-5D-5L
Time Frame: 90 Days
The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment of the participant's quality of life. The score ranges from a minimum score of -0.573 to a maximum score of 1, with higher scores indicating higher health utility. Negative numbers correspond to a self-assessed health state worse than being dead.
90 Days
Phase II (RCT): Manipulation Under Anesthesia (MUA)
Time Frame: 90 Days
The number of subjects with a manipulation under anesthesia (MUA) within 90 days after knee replacement surgery.
90 Days
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.
90 Days
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.
90 Days
Phase II (RCT): Subject Satisfaction
Time Frame: 90 Days

Comparison of subject satisfaction survey results between the study groups.

The Knee Society Scoring System (KSS) satisfaction score ranges from 0 to 40, with higher scores indicating greater satisfaction.
90 Days
Phase II RCT: Urgent Care Center and Emergency Room Visits
Time Frame: 90 Days
The number of subjects with urgent care visits or emergency room visits within 90 days after knee or hip replacement surgery.
90 Days
Phase I (Pilot): 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.
90 Days
Phase I (Pilot): 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.
90 Days
Phase III (Correlative): 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.
90 Days
Phase III (Correlative): 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.
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Hillary Overholser, Zimmer Biomet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLU2018-13CH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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