A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

• ClinicalTrials.gov Identifier: NCT03737149
• Recruitment Status: Recruiting
• First Posted: November 9, 2018
• Last Update Posted: May 26, 2023
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee; Osteoarthritis, Hip	Other: mymobility with Apple Watch	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10500 participants
• Allocation: Randomized
• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Phase II RCT: Subject Satisfaction [ Time Frame: 90 Days ]
   Comparison of subject satisfaction survey results between the study groups.
8. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Scott Abshagen, BS, RN, CCRP; 574-453-7099; scott.abshagen@zimmerbiomet.com

Locations

United States, California

Sah Orthopaedic Associates; Recruiting

Fremont, California, United States, 94538

Contact: Marie Sabado-Bell marie@sahortho.com

Principal Investigator: Alexander Sah, MD

Hoag Orthopedic Institute; Recruiting

Irvine, California, United States, 92618

Contact: Kalyn Smith Kalyn.Smith@hoagorthopedics.org

Principal Investigator: Steven Barnett, MD

Sub-Investigator: Jay Patel, MD

Sub-Investigator: Travis Scudday, MD

Sub-Investigator: Nader Nassif, MD

Sub-Investigator: Stephen Mikulak, MD

Stanford University; Recruiting

Redwood City, California, United States, 94063

Contact: Angela Bye abye@stanford.edu

Principal Investigator: James Huddleston, MD

Sub-Investigator: Matt Miller, MD

Sub-Investigator: Stuart Goodman, MD

Sub-Investigator: Derek Amanatullah, MD

United States, Colorado

Colorado Joint Replacement; Recruiting

Denver, Colorado, United States, 80210

Contact: Rose Johnson roseannjohnson@centura.org

Principal Investigator: Todd Miner, MD

Panorama Orthopedics & Spine Center; Recruiting

Denver, Colorado, United States, 80401

Contact: Research Department research@panoramaortho.com

Principal Investigator: Jared Foran, MD

Sub-Investigator: Bharat Desai, MD

Sub-Investigator: William Peace, MD

Sub-Investigator: Jeremy Kinder, MD

Sub-Investigator: Jesse Chrastil, MD

United States, Florida

Foundation for Orthopedic Research and Education; Recruiting

Temple Terrace, Florida, United States, 33637

Contact: Kathy Kops kkops@foreonline.org

Principal Investigator: Steven Lyons, MD

Sub-Investigator: Kenneth Gustke, MD

Sub-Investigator: Christopher Grayson, MD

Sub-Investigator: Michael Miranda, DO

Sub-Investigator: Brian Palumbo, MD

Sub-Investigator: Thomas Bernasek, MD

Sub-Investigator: Kurt Hirshorn, MD

Sub-Investigator: Spencer Smith, DO

Cleveland Clinic Florida; Active, not recruiting

Weston, Florida, United States, 33331

United States, Georgia

Emory University; Active, not recruiting

Atlanta, Georgia, United States, 30329

United States, Illinois

Rush University Medical Center; Terminated

Chicago, Illinois, United States, 60612

United States, Indiana

Midwest Center for Joint Replacement; Recruiting

Indianapolis, Indiana, United States, 46241

Contact: Grant Foley gfoley@mcjr.com

Principal Investigator: Wesley Lackey, MD

Sub-Investigator: Michael Berend, MD

Sub-Investigator: Joshua Carter, MD

United States, Kentucky

Bluegrass Orthopaedics; Recruiting

Lexington, Kentucky, United States, 40509

Contact: Daniel Wicker daniel.wicker@bluegrassortho.com

Principal Investigator: Christian Christensen, MD

Sub-Investigator: Kevin Denehy, MD

United States, Maryland

OrthoBethesda; Recruiting

Bethesda, Maryland, United States, 20817

Contact: Angel Rego arego@alignedortho.com

Principal Investigator: Christopher Cannova, MD

Sub-Investigator: Sridhar Durbhakula, MD

United States, Massachusetts

Newton-Wellesley Hospital; Recruiting

Newton, Massachusetts, United States, 02462

Contact: Catharine Tumpowsky ctumpowsky@partners.org

Principal Investigator: Hany Bedair, MD

Sub-Investigator: Christopher Melnic, MD

United States, Michigan

Ascension Medical Group - University Orthopaedic Specialists; Recruiting

Rochester Hills, Michigan, United States, 48307

Contact: Kayla Chattinger kayla.chattinger@ascension.org

Principal Investigator: Jeffrey DeClaire, MD

Sub-Investigator: Nicholas Frisch, MD

Michigan Orthopaedic Surgeons; Recruiting

Southfield, Michigan, United States, 48075

Contact: Brianna Buchanan bbuchanan@miorthosurgeons.com

Principal Investigator: Michael Flierl, MD

Sub-Investigator: Donald Knapke, MD

Sub-Investigator: Jeffrey Devitt, MD

Sub-Investigator: Hassan Alosh, MD

United States, Missouri

Washington University; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Jackie King jackie.king@wustl.edu

Contact: Venessa Riegler rieglerv@wustl.edu

Principal Investigator: Robert Barrack, MD

Sub-Investigator: John Clohisy, MD

Sub-Investigator: Ryan Nunley, MD

Sub-Investigator: Charles Hannon, MD

United States, New Jersey

Rothman Institute; Active, not recruiting

Rutherford, New Jersey, United States, 07070

United States, New Mexico

New Mexico Orthopaedic Associates; Active, not recruiting

Albuquerque, New Mexico, United States, 87110

United States, North Carolina

Duke University; Recruiting

Morrisville, North Carolina, United States, 27560

Contact: Jennifer Friend jennifer.friend@duke.edu

Principal Investigator: Samuel Wellman, MD

Sub-Investigator: Michael Bolognesi, MD

Sub-Investigator: Thorsten Seyler, MD

Sub-Investigator: William Jiranek, MD

Sub-Investigator: Sean Ryan, MD

United States, Ohio

Cleveland Clinic Main Campus; Active, not recruiting

Cleveland, Ohio, United States, 44195

JIS Orthopedics; Recruiting

New Albany, Ohio, United States, 43054

Contact: Michael Sneller snellerma@jisortho.com

Principal Investigator: Adolph Lombardi, Jr, FACS, MD

Sub-Investigator: Keith Berend, MD

Sub-Investigator: Jason Hurst, MD

Sub-Investigator: Michael Morris, MD

Sub-Investigator: David Crawford, MD

United States, Oregon

Orthopedic + Fracture Specialists; Recruiting

Portland, Oregon, United States, 97225

Contact: Jacquline Shelton jacquline.shelton@OandFS.com

Principal Investigator: Alex DeHaan, MD

Sub-Investigator: Brett Andres, MD

Sub-Investigator: Alec Denes, Jr, MD

Sub-Investigator: Jason Kurian, MD

Sub-Investigator: Elizabeth Lieberman, MD

ROC Orthopedics; Recruiting

Tualatin, Oregon, United States, 97062

Contact: Annette Tieu avotr@rocpdx.com

Principal Investigator: James Ballard, MD

Sub-Investigator: John Coen, MD

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Artsiom Meliukh artsiom.meliukh@pennmedicine.upenn.edu

Contact: Warren Harding warren.harding@pennmedicine.upenn.edu

Principal Investigator: Craig Israelite, MD

Sub-Investigator: Charles Nelson, MD

Sub-Investigator: Eric Hume, MD

Sub-Investigator: Neil Sheth, MD

Sub-Investigator: Christopher Travers, MD

Rothman Institute; Active, not recruiting

Philadelphia, Pennsylvania, United States, 19107

United States, Utah

University of Utah; Recruiting

Salt Lake City, Utah, United States, 84108

Contact: Claire Kapron claire.kapron@hsc.utah.edu

Principal Investigator: Jeremy Gililland, MD

Sub-Investigator: Christopher Peters, MD

Sub-Investigator: Christopher Pelt, MD

Sub-Investigator: Lucas Anderson, MD

Sub-Investigator: Michael Archibeck, MD

Australia, Australian Capital Territory

National Capital Private Hospital; Recruiting

Canberra, Australian Capital Territory, Australia, 2605

Contact: Ricardo Torres RTorres@canberrakneeclinic.com.au

Principal Investigator: Brendan Klar

Australia, Victoria

Epworth Healthcare - Richmond; Recruiting

Richmond, Victoria, Australia, 3121

Contact: Stasie Abela stasie.abela@epworth.org.au

Principal Investigator: Cam Fary

Sub-Investigator: Richard DeSteiger

Sub-Investigator: David Love

Italy

Policlinico Universitario Campus Bio-Medico; Terminated

Roma, Italy

Netherlands

St. Annaziekenhuis; Recruiting

Geldrop, Netherlands

Contact: Walter van der Weegen w.vander.weegen@st-anna.nl

Principal Investigator: Walter van der Weegen

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Study Director: Erin Osborn; Zimmer Biomet

More Information

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT03737149
• Other Study ID Numbers: CLU2018-13CH
• First Posted: November 9, 2018
• Last Update Posted: May 26, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zimmer Biomet:

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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases