A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

NCT03737149 | Completed Results

• 1 other identifier: CLU2018-13CH
• Study Type: interventional
• Target: 6,559
• Locations: 4 countries
• Sites: 30

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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Knee Replacement; Knee Arthroplasty; Hip Replacement; Hip Arthroplasty; Joint Replacement; Physical Therapy; Partial Knee Replacement; Hip Pain, Chronic; Knee Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Phase II (RCT): Readmissions

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

  30 Days

Secondary Outcomes (12)

• Phase II (RCT): Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR)

  90 Days

• Phase II (RCT): Hip Disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR)

  90 Days

• Phase II RCT: EQ-5D-5L

  90 Days

• Phase II (RCT): Manipulation Under Anesthesia (MUA)

  90 Days

• Phase II (RCT): Timed Up and Go (TUG)

  90 Days

Study Arms (2)

mymobility with Apple Watch

EXPERIMENTAL

Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.

Other: mymobility with Apple Watch

Standard of Care Physical Therapy

NO INTERVENTION

Standard of care patient education and post-operative physical therapy, as determined by local site guidelines and care pathways.

Interventions

mymobility with Apple Watch OTHER

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.

mymobility with Apple Watch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (30)

Sah Orthopaedic Associates

Fremont, California, 94538, United States

Location

Hoag Orthopedic Institute

Irvine, California, 92618, United States

Location

Stanford University

Redwood City, California, 94063, United States

Location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

Location

Panorama Orthopedics & Spine Center

Golden, Colorado, 80401, United States

Location

Foundation for Orthopedic Research and Education

Temple Terrace, Florida, 33637, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Midwest Center for Joint Replacement

Indianapolis, Indiana, 46241, United States

Location

Bluegrass Orthopaedics

Lexington, Kentucky, 40509, United States

Location

OrthoBethesda

Bethesda, Maryland, 20817, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Ascension Medical Group - University Orthopaedic Specialists

Rochester Hills, Michigan, 48307, United States

Location

Michigan Orthopaedic Surgeons

Troy, Michigan, 48084, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Rothman Institute

Montvale, New Jersey, 07645, United States

Location

New Mexico Orthopaedic Associates

Albuquerque, New Mexico, 87110, United States

Location

Duke University

Morrisville, North Carolina, 27560, United States

Location

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

JIS Orthopedics

New Albany, Ohio, 43054, United States

Location

Orthopedic + Fracture Specialists

Portland, Oregon, 97225, United States

Location

ROC Orthopedics

Tualatin, Oregon, 97062, United States

Location

Rothman Institute

Bryn Mawr, Pennsylvania, 19010, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

National Capital Private Hospital

Canberra, Australian Capital Territory, 2605, Australia

Location

Epworth Healthcare - Richmond

Richmond, Victoria, 3121, Australia

Location

Policlinico Universitario Campus Bio-Medico

Roma, Italy

Location

St. Annaziekenhuis

Geldrop, Netherlands

Location

Related Publications (37)

• 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.

  PMID: 34053272 RESULT

• 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.

  PMID: 34192907 RESULT

• 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.

  PMID: 34462184 RESULT

• 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.

  PMID: 36889524 RESULT

• 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.

  PMID: 36996947 RESULT

• 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.

  PMID: 37068568 RESULT

• 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.

  PMID: 37088222 RESULT

• 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.

  PMID: 37420754 RESULT

• 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.

  PMID: 37514832 RESULT

• 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.

  PMID: 37717829 RESULT

• 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.

  PMID: 37852452 RESULT

• 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.

  PMID: 38044446 RESULT

• 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.

  PMID: 38202132 RESULT

• 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.

  PMID: 38211730 RESULT

• 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.

  PMID: 38309635 RESULT

• Tripuraneni KR, Anderson MB, Cholewa JM, Smith K, VanAndel DC, Redfern RE, Barnett SL. Is There a Change in Anxiety and Depression Following Total Knee Arthroplasty? J Arthroplasty. 2024 Sep;39(9S2):S185-S190. doi: 10.1016/j.arth.2024.02.009. Epub 2024 Feb 10.

  PMID: 38346581 RESULT

• Nelson CL, Sheth NP, Higuera Rueda CA, Redfern RE, Van Andel DC, Anderson MB, Cholewa JM, Israelite CL. Impact of Chronic Opioid Use on Postoperative Mobility Recovery and Patient-Reported Outcomes: A Propensity-Matched Study. J Arthroplasty. 2024 Aug;39(8S1):S148-S153. doi: 10.1016/j.arth.2024.02.032. Epub 2024 Feb 22.

  PMID: 38401614 RESULT

• Huffman N, Pasqualini I, Redfern RE, Murray TG, Deren ME, Israelite CL, Nelson CL, Van Andel D, Cholewa JM, Anderson MB, Klika AK, McLaughlin JP, Piuzzi NS. Patient satisfaction and patient-reported outcomes do not vary by BMI class in total hip arthroplasty. Eur J Orthop Surg Traumatol. 2024 May;34(4):1979-1985. doi: 10.1007/s00590-024-03894-x. Epub 2024 Mar 15.

  PMID: 38488936 RESULT

• Sarhan O, Megalla M, Imam N, Ren AN, Redfern RE, Klein GR. Improved patient reported outcomes with the direct anterior approach versus the posterior approach for total hip arthroplasty in the early post-operative period. Arch Orthop Trauma Surg. 2024 May;144(5):2373-2380. doi: 10.1007/s00402-024-05271-z. Epub 2024 Mar 23.

  PMID: 38520548 RESULT

• Sarhan OA, Imam N, Levine HB, Redfern RE, Seidenstein AD, Klein GR. Comparison of Early Postoperative Step and Stair Counts With the Direct Anterior Approach Versus the Posterior Approach for Total Hip Arthroplasty. J Arthroplasty. 2024 Nov;39(11):2780-2786. doi: 10.1016/j.arth.2024.04.069. Epub 2024 Apr 30.

  PMID: 38697321 RESULT

• Huffman N, Pasqualini I, Khan ST, Klika AK, McLaughlin JP, Higuera-Rueda CA, Deren ME, Piuzzi NS. Stepping up recovery: integrating patient reported outcome measures and wearable technology for 90-day rehabilitation following total hip arthroplasty. Arch Orthop Trauma Surg. 2024 Dec 21;145(1):80. doi: 10.1007/s00402-024-05618-6.

  PMID: 39708092 RESULT

• Ingawa HS, Rainey JP, Kapron CR, Blackburn BE, Pelt CE, Peters CL, Gililland JM, Anderson LA, Archibeck MJ. Stairway to Heavenly Results: Do Stairs Affect Postoperative Recovery After Total Joint Arthroplasty? J Arthroplasty. 2025 Nov 9:S0883-5403(25)01433-0. doi: 10.1016/j.arth.2025.11.007. Online ahead of print.

  PMID: 41218689 RESULT

• Wu KA, Kugelman DN, Goel RK, Dilbone ES, Shenoy D, Ryan SP, Wellman SS, Bolognesi MP, Seyler TM. Wearable health technology finds improvements in daily physical activity levels following total knee arthroplasty: A prospective study. Knee Surg Sports Traumatol Arthrosc. 2025 Sep;33(9):3218-3227. doi: 10.1002/ksa.12675. Epub 2025 Apr 13.

  PMID: 40221914 RESULT

• Sarhan OA, Imam N, Levine HB, Redfern RE, Ren AN, Seidenstein AD, Klein GR. Anterior total hip arthroplasty is associated with lower risk of revision but higher odds of delayed wound healing. Arch Orthop Trauma Surg. 2025 Apr 1;145(1):218. doi: 10.1007/s00402-025-05844-6.

  PMID: 40167818 RESULT

• Kugelman DN, Wu KA, Goel RK, Dilbone ES, Ryan SP, Bolognesi MP, Seyler TM, Wellman SS. Comparing Functional Recovery Between Total and Unicompartmental Knee Arthroplasty: A Prospective Health Kit Study. J Arthroplasty. 2025 Jul;40(7S1):S84-S87. doi: 10.1016/j.arth.2025.03.061. Epub 2025 Mar 26.

  PMID: 40154583 RESULT

• Wu KA, Kugelman DN, Goel RK, Dilbone ES, Ryan SP, Wellman SS, Bolognesi MP, Seyler TM. How Do Patient-Reported Outcomes Correlate With Real-Time Objective Measures of Function After Total Knee Arthroplasty? A Prospective Study Using Daily Gait Metrics. J Arthroplasty. 2025 Jul;40(7):1711-1718. doi: 10.1016/j.arth.2024.12.007. Epub 2024 Dec 10.

  PMID: 39667590 RESULT

• Miner TM, Anderson MB, Van Andel DC, Neher RE, Redfern RE, Duwelius PJ. Evaluating Self-Directed Rehabilitation for Knee and Hip Arthroplasty During the COVID-19 Pandemic: A Multicenter Study. Med Sci (Basel). 2024 Nov 26;12(4):69. doi: 10.3390/medsci12040069.

  PMID: 39728418 RESULT

• Wu KA, Dilbone ES, Kugelman DN, Goel RK, Ryan SP, Wellman SS, Bolognesi MP, Seyler TM. Daily physical activity following unicompartmental knee arthroplasty: A pilot study. J Exp Orthop. 2024 Nov 14;11(4):e70048. doi: 10.1002/jeo2.70048. eCollection 2024 Oct.

  PMID: 39553421 RESULT

• Pasqualini I, Huffman N, Klika A, Kamath AF, Higuera-Rueda CA, Deren ME, Murray TG, Piuzzi NS. Stepping Up Recovery: Integrating Patient-reported Outcome Measures and Wearable Technology for Rehabilitation Following Knee Arthroplasty. J Knee Surg. 2024 Aug;37(10):757-763. doi: 10.1055/a-2315-8110. Epub 2024 Apr 27.

  PMID: 38677297 RESULT

• Ribeiro-Castro AL, Surmacz K, Aguilera-Canon MC, Anderson MB, Van Andel D, Redfern RE, Cook CE. Early post-operative walking bouts are associated with improved gait speed and symmetry at 90 days. Gait Posture. 2024 Jan;107:130-135. doi: 10.1016/j.gaitpost.2023.05.014. Epub 2023 May 20.

  PMID: 37271590 RESULT

• Surmacz K, Ribeiro-Castro AL, Anderson MB, Van Andel D, Redfern RE, Duwelius PJ. A Retrospective Study on the Feasibility of Using Low-burden Patient-reported Pain Scores to Track Recovery and Outcomes After Total Joint Replacement. Arthroplast Today. 2024 Feb 6;26:101297. doi: 10.1016/j.artd.2023.101297. eCollection 2024 Apr.

  PMID: 38352707 RESULT

• Redfern RE, Crawford DA, Lombardi AV Jr., Tripuraneni KR, Van Andel DC, Anderson MB, Cholewa JM. Patients with High Pre-Operative Physical Activity Take Longer to Return to Baseline. Surgeries. 2024; 5(2):220-233. https://doi.org/10.3390/surgeries5020021

  RESULT

• Surmacz K, Redfern RE, Van Andel DC, Kamath AF. Machine learning model identifies patient gait speed throughout the episode of care, generating notifications for clinician evaluation. Gait Posture. 2024 Oct;114:62-68. doi: 10.1016/j.gaitpost.2024.09.001. Epub 2024 Sep 6.

  PMID: 39260073 RESULT

• Redfern RE, Crawford DA, Anderson MB, Van Andel DC, Cholewa JM, Lombardi AV Jr. How Do Patients Above Patient Acceptable Symptom State Pre-Operatively Recover Following Total Knee Arthroplasty? Surgeries. 2024; 5(4):1091-1101. https://doi.org/10.3390/surgeries5040088

  RESULT

• Lonner JH, Naidu-Helm A, Van Andel D, Anderson MB, Ditto R, Redfern RE, Foran J. Smartphone-Based Care Platform Versus Traditional Care in Primary Knee Arthroplasty in the Unites States: Cost Analysis. JMIR Mhealth Uhealth. 2025 Feb 3;13:e46047. doi: 10.2196/46047.

  PMID: 39899745 RESULT

• Cholewa JM, Anderson MB, Tripuraneni KR, Lonner JH, Redfern RE. "Neutral Satisfied" Patients Should Not Be Dichotomized to "Satisfied" or "Dissatisfied" in Patient-Reported Outcomes After Total Knee Arthroplasty. J Clin Med. 2025 Jun 24;14(13):4482. doi: 10.3390/jcm14134482.

  PMID: 40648855 RESULT

• Surmacz K, Cholewa J, Anderson MB, Redfern RE, VanAndel D, Tripuraneni KR. One-Month Postoperative Pain Predicts 3-Month Postoperative Dissatisfaction in Total Knee Arthroplasty Patients. J Am Acad Orthop Surg Glob Res Rev. 2026 Jan 2;10(1):e25.00140. doi: 10.5435/JAAOSGlobal-D-25-00140. eCollection 2026 Jan 1.

  PMID: 41494088 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Results Point of Contact

• Title: Scott Abshagen
• Organization: Zimmer Biomet

scott.abshagen@zimmerbiomet.com

574-453-7099

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 9, 2018
• Study Start: October 22, 2018
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); US (26); NL (1); IT (1)