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Osteoarthritis, KneeNCT03737149

A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

A study testing mymobility with Apple Watch in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Zimmer Biomet at 30 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee, Osteoarthritis, Hip
What is being tested?
mymobility with Apple Watch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,559 participants
Where
30 sitesin 4 countries
Study dates
22 Oct 2018to 15 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be 18 years of age or older.
  • Subject qualifies for a primary, unilateral total or partial knee 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 4 countries.

30 sites in 4 countries

United States26 sites
  • New Mexico Orthopaedic Associates

    Albuquerque, New Mexico, 87110

  • Emory University

    Atlanta, Georgia, 30329

  • OrthoBethesda

    Bethesda, Maryland, 20817

  • Rothman Institute

    Bryn Mawr, Pennsylvania, 19010

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • Colorado Joint Replacement

    Denver, Colorado, 80210

  • Sah Orthopaedic Associates

    Fremont, California, 94538

  • Panorama Orthopedics & Spine Center

    Golden, Colorado, 80401

  • Midwest Center for Joint Replacement

    Indianapolis, Indiana, 46241

  • Hoag Orthopedic Institute

    Irvine, California, 92618

  • Bluegrass Orthopaedics

    Lexington, Kentucky, 40509

  • Rothman Institute

    Montvale, New Jersey, 07645

  • Duke University

    Morrisville, North Carolina, 27560

  • JIS Orthopedics

    New Albany, Ohio, 43054

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Orthopedic + Fracture Specialists

    Portland, Oregon, 97225

  • Stanford University

    Redwood City, California, 94063

  • Ascension Medical Group - University Orthopaedic Specialists

    Rochester Hills, Michigan, 48307

  • University of Utah

    Salt Lake City, Utah, 84108

  • Washington University

    St Louis, Missouri, 63110

  • Foundation for Orthopedic Research and Education

    Temple Terrace, Florida, 33637

  • Michigan Orthopaedic Surgeons

    Troy, Michigan, 48084

  • ROC Orthopedics

    Tualatin, Oregon, 97062

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Australia2 sites
  • National Capital Private Hospital

    Canberra, Australian Capital Territory, 2605

  • Epworth Healthcare - Richmond

    Richmond, Victoria, 3121

Other trials in Australia

Italy1 site
  • Policlinico Universitario Campus Bio-Medico

    Roma

Other trials in Italy

Netherlands1 site
  • St. Annaziekenhuis

    Geldrop

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
mymobility with Apple Watch
Keywords
Knee Replacement, Knee Arthroplasty, Hip Replacement, Hip Arthroplasty, Joint Replacement, Physical Therapy, Partial Knee Replacement, Hip Pain, Chronic, Knee Pain, Chronic
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mymobility with Apple WatchOther

    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.

Study groups in NCT03737149
Study groupRoleWhat they receive
mymobility with Apple WatchExperimentalPost-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
Receives: Other: mymobility with Apple Watch
Standard of Care Physical TherapyNo interventionStandard of care patient education and post-operative physical therapy, as determined by local site guidelines and care pathways.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase II (RCT): Readmissions

    The number of subjects with a readmission within 30 days after knee or hip replacement surgery.

    Measured: 30 Days

Secondary outcomes (12)
  1. 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.

    Measured: 90 Days

  2. 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.

    Measured: 90 Days

  3. Phase II RCT: EQ-5D-5L

    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.

    Measured: 90 Days

  4. Phase II (RCT): Manipulation Under Anesthesia (MUA)

    The number of subjects with a manipulation under anesthesia (MUA) within 90 days after knee replacement surgery.

    Measured: 90 Days

  5. 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.

    Measured: 90 Days

  6. 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.

    Measured: 90 Days

  7. Phase II (RCT): Subject Satisfaction

    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.

    Measured: 90 Days

  8. Phase II RCT: Urgent Care Center and Emergency Room Visits

    The number of subjects with urgent care visits or emergency room visits within 90 days after knee or hip replacement surgery.

    Measured: 90 Days

  9. Phase I (Pilot): 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.

    Measured: 90 Days

  10. Phase I (Pilot): 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.

    Measured: 90 Days

  11. Phase III (Correlative): 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.

    Measured: 90 Days

  12. Phase III (Correlative): 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.

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2018
  2. Study start22 Oct 2018
  3. Primary completion15 Apr 2025
  4. Study completion15 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
6,559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737149
Sponsor's protocol ID
CLU2018-13CH
Status last verified
Mar 2026
First submitted
26 Oct 2018
Last updated
23 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Crawford DA, Duwelius PJ, Sneller MA, Morris MJ, Hurst JM, Berend KR, Lombardi AV. 2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial. Bone Joint J. 2021 Jun;103-B(6 Supple A):3-12. doi: 10.1302/0301-620X.103B6.BJJ-2020-2352.R1.

    PubMed 34053272
  • Crawford DA, Lombardi AV Jr, Berend KR, Huddleston JI 3rd, Peters CL, DeHaan A, Zimmerman EK, Duwelius PJ. Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial. Bone Joint J. 2021 Jul;103-B(7 Supple B):91-97. doi: 10.1302/0301-620X.103B7.BJJ-2020-2402.R1.

    PubMed 34192907
  • Tripuraneni KR, Foran JRH, Munson NR, Racca NE, Carothers JT. A Smartwatch Paired With A Mobile Application Provides Postoperative Self-Directed Rehabilitation Without Compromising Total Knee Arthroplasty Outcomes: A Randomized Controlled Trial. J Arthroplasty. 2021 Dec;36(12):3888-3893. doi: 10.1016/j.arth.2021.08.007. Epub 2021 Aug 9.

    PubMed 34462184
  • Alexander JS, Redfern RE, Duwelius PJ, Berend KR, Lombardi AV Jr, Crawford DA. Use of a Smartphone-Based Care Platform After Primary Partial and Total Knee Arthroplasty: 1-Year Follow-Up of a Prospective Randomized Controlled Trial. J Arthroplasty. 2023 Jul;38(7 Suppl 2):S208-S214. doi: 10.1016/j.arth.2023.02.082. Epub 2023 Mar 6.

    PubMed 36889524
  • Christensen JC, Blackburn BE, Anderson LA, Gililland JM, Peters CL, Archibeck MJ, Pelt CE. Recovery Curve for Patient Reported Outcomes and Objective Physical Activity After Primary Total Knee Arthroplasty-A Multicenter Study Using Wearable Technology. J Arthroplasty. 2023 Jun;38(6S):S94-S102. doi: 10.1016/j.arth.2023.03.060. Epub 2023 Mar 28.

    PubMed 36996947
  • Sato EH, Stevenson KL, Blackburn BE, Peters CL, Archibeck MJ, Pelt CE, Gililland JM, Anderson LA. Recovery Curves for Patient Reported Outcomes and Physical Function After Total Hip Arthroplasty. J Arthroplasty. 2023 Jul;38(7S):S65-S71. doi: 10.1016/j.arth.2023.04.012. Epub 2023 Apr 15.

    PubMed 37068568
  • Booth MW, Riegler V, King JS, Barrack RL, Hannon CP. Patients' Perceptions of Remote Monitoring and App-Based Rehabilitation Programs: A Comparison of Total Hip and Knee Arthroplasty. J Arthroplasty. 2023 Jul;38(7S):S39-S43. doi: 10.1016/j.arth.2023.04.032. Epub 2023 Apr 23.

    PubMed 37088222
  • Fary C, Cholewa J, Abshagen S, Van Andel D, Ren A, Anderson MB, Tripuraneni KR. Stepping beyond Counts in Recovery of Total Knee Arthroplasty: A Prospective Study on Passively Collected Gait Metrics. Sensors (Basel). 2023 Jun 14;23(12):5588. doi: 10.3390/s23125588.

    PubMed 37420754
  • Fary C, Cholewa J, Abshagen S, Van Andel D, Ren A, Anderson MB, Tripuraneni K. Stepping Beyond Counts in Recovery of Total Hip Arthroplasty: A Prospective Study on Passively Collected Gait Metrics. Sensors (Basel). 2023 Jul 20;23(14):6538. doi: 10.3390/s23146538.

    PubMed 37514832
  • Sato EH, Stevenson KL, Blackburn BE, Peters CL, Archibeck MJ, Pelt CE, Gililland JM, Anderson LA. Impact of Demographic Variables on Recovery After Total Hip Arthroplasty. J Arthroplasty. 2024 Mar;39(3):721-726. doi: 10.1016/j.arth.2023.09.012. Epub 2023 Sep 17.

    PubMed 37717829
  • DeMik DE, Lonner JH, Cholewa JM, Anderson MB, Kamath AF, Tripuraneni KR. Association Between Digitally Provided Education and 90-Day Return to Sexual Activity Following Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2024 Apr;39(4):916-920. doi: 10.1016/j.arth.2023.10.014. Epub 2023 Oct 16.

    PubMed 37852452
  • Fary C, Cholewa J, Ren AN, Abshagen S, Anderson MB, Tripuraneni K. Multicenter, prospective cohort study: immediate postoperative gains in active range of motion following robotic-assisted total knee replacement compared to a propensity-matched control using manual instrumentation. Arthroplasty. 2023 Dec 4;5(1):62. doi: 10.1186/s42836-023-00216-0.

    PubMed 38044446
  • Redfern RE, Crawford DA, Lombardi AV Jr, Tripuraneni KR, Van Andel DC, Anderson MB, Cholewa JM. Outcomes Vary by Pre-Operative Physical Activity Levels in Total Knee Arthroplasty Patients. J Clin Med. 2023 Dec 25;13(1):125. doi: 10.3390/jcm13010125.

    PubMed 38202132
  • Miller MD, Redfern RE, Anderson MB, Abshagen S, Van Andel D, Lonner JH. Completion of Patient-Reported Outcome Measures Improved With Use of a Mobile Application in Arthroplasty Patients: Results From a Randomized Controlled Trial. J Arthroplasty. 2024 Jul;39(7):1656-1662. doi: 10.1016/j.arth.2024.01.007. Epub 2024 Jan 10.

    PubMed 38211730
  • Pasqualini I, Huffman N, Redfern RE; Digital Health in Arthroplasty Writing Committee; Piuzzi NS. Despite Greater Improvement in Pain and Function Among Obese Patients Shortly After Total Knee Arthroplasty, There is No Difference in Patient-Reported Outcomes and Satisfaction Between Body Mass Index Classes at 1 Year Postoperatively. J Arthroplasty. 2024 Jul;39(7):1719-1725.e1. doi: 10.1016/j.arth.2024.01.043. Epub 2024 Feb 2.

    PubMed 38309635

Questions about this trial

What is this clinical trial studying?

A study testing mymobility with Apple Watch in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Zimmer Biomet at 30 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Australia, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II (RCT): Readmissions (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03737149, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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