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A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

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ClinicalTrials.gov Identifier: NCT03737149
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Accelero Health Partners, LLC
Information provided by (Responsible Party):
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.

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 Zimmer Biomet 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.

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 : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.



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.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subject must be 18 years of age or older.
  • Subject is indicated for a primary, unilateral total or partial knee arthroplasty, or total hip arthroplasty based on physical exam and with a medical history diagnosis of Osteoarthritis (OA).
  • Investigator plans to treat subject with a Zimmer Biomet device as part of their clinical care.
  • Subject must own and maintain an iPhone 6 or newer.
  • Subject must be willing and able to complete the protocol required follow-up.
  • Subjects must be able to read and understand English.
  • Subject is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB approved Informed Consent and Authorization form (ICF).
  • Subject is mobile with no more than a single cane/single crutch assist.

Exclusion Criteria:

  • Subject is a current alcohol or drug abuser.
  • Subject is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
  • Subject is currently participating in any other surgical intervention, physical therapy or pain management study.
  • Subject requires simultaneous or staged bilateral replacements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737149


Contacts
Contact: Erin Osborn, MBA, CCRP 574-371-9884 Erin.Osborn@zimmerbiomet.com
Contact: Dave VanAndel, MS 616.304.9282 Dave.VanAndel@zimmerbiomet.com

Locations
United States, Arizona
OrthoArizona Not yet recruiting
Scottsdale, Arizona, United States, 85254
Principal Investigator: David A Camarata, MD         
United States, California
Hoag Orthopedic Institute Recruiting
Irvine, California, United States, 92618
Contact: Marie-Claire Fickenscher    949-255-9753    mcfickenscher@hoagorthopedics.org   
Principal Investigator: Steven L Barnett, `MD         
Sub-Investigator: Jay J Patel, MD         
Sub-Investigator: Travis Scudday, MD         
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94158
Contact: Michael Henne, MPH    415-514-6064    Michael.Henne@ucsf.edu   
Principal Investigator: Stefano Bini, MD         
United States, Colorado
Colorado Joint Replacement Not yet recruiting
Denver, Colorado, United States, 80210
Contact: Rose Johnson, CCRP    303-260-2940    roseannjohnson@centura.org   
Principal Investigator: Todd Miner, MD         
Sub-Investigator: Jason Jennings, MD         
Sub-Investigator: Charlie Yang, MD         
Panorama Orthopedics & Spine Center Not yet recruiting
Denver, Colorado, United States, 80401
Contact: Panorama Orthopedics & Spine Center    303-233-1223      
Principal Investigator: Jared Foran, MD         
Principal Investigator: Bharat M Desai, MD         
Sub-Investigator: William Peace, MD         
Sub-Investigator: Jeremy Kinder, MD         
United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30329
Contact: Jared O'Neal    404-778-8051    jwoneal@emory.edu   
Principal Investigator: Thomas L Bradbury, MD         
Sub-Investigator: Greg A Erens, MD         
Sub-Investigator: George Guild, MD         
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Chris Culvern, MS    312-432-2470    chris.culvern@rushortho.com   
Principal Investigator: Craig J Della Valle, MD         
Sub-Investigator: Richard A Berger, MD         
United States, Indiana
Midwest Center for Joint Replacement Recruiting
Indianapolis, Indiana, United States, 46241
Contact: Haley Schwartz    317-455-1064    hschwartz@mcjr.com   
Principal Investigator: Wesley Lackey, MD         
Sub-Investigator: Michael Berend, MD         
Sub-Investigator: Joshua Carter, MD         
United States, Maryland
OrthoBethesda Not yet recruiting
Bethesda, Maryland, United States, 20817
Contact: Armandi Smith    301-530-1010    OrthoResearch@bcc-ortho.com   
Principal Investigator: Christopher J Cannova, MD         
United States, Massachusetts
Newton-Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Maureen Dwyer, PhD, ATC    617-243-6493    mkdwyer@partners.org   
Principal Investigator: Hany S Bedair, MD         
Sub-Investigator: Andrew A Freiberg, MD         
United States, Michigan
DeClaire LaMacchia Orthopaedic Institute Not yet recruiting
Rochester Hills, Michigan, United States, 48307
Principal Investigator: Jeffrey H DeClaire, MD         
United States, New Jersey
Hartzband Center for Hip & Knee Replacement Not yet recruiting
Paramus, New Jersey, United States, 07652
Contact: Hartzband Center for Hip & Knee Replacement    201-291-4040      
Principal Investigator: Gregg R Klein, MD         
Sub-Investigator: Harlan B Levine, MD         
United States, New Mexico
New Mexico Orthopaedic Associates, PC Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Natalie Munson    505-239-3174    MunsonNR@nmortho.net   
Principal Investigator: Samuel Tabet, MD         
Sub-Investigator: Joshua Carothers, MD         
Sub-Investigator: Krishna Tripuraneni, MD         
United States, Ohio
Joint Implant Surgeons, Inc. Recruiting
New Albany, Ohio, United States, 43054
Contact: Michael Sneller    614-221-6331 ext 347    SnellerMA@joint-surgeons.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: Jason Reed, MD         
Sub-Investigator: David Crawford, MD         
United States, Oregon
Oregon Orthopedic & Sports Medicine Clinic Not yet recruiting
Oregon City, Oregon, United States, 97045
Contact: Miranda Burge         
Principal Investigator: James C Ballard, MD         
Orthopedic + Fracture Specialists Not yet recruiting
Portland, Oregon, United States, 97225
Contact: Erin Zimmerman    503-214-5259    erin.zimmerman@oandfs.com   
Contact: Sheila Kisor, MEd,MBA, CMPE    503-214-5296    sheila.kisor@OandFS.com   
Principal Investigator: Paul J Duwelius, MD         
Sub-Investigator: Alex M DeHaan, MD         
Sub-Investigator: Brett M Andres, MD         
United States, Pennsylvania
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Annamarie Horan, MPA, PhD, CCRC, CPI    215-294-9132    Annamarie.Horan@uphs.upenn.edu   
Principal Investigator: Craig L Israelite, MD         
Principal Investigator: Charles L Nelson, MD         
United States, Utah
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84108
Contact: Priscila Monteiro, MSc, BScPT    801-213-0961    monteiro.priscila@utah.edu   
Principal Investigator: Jeremy Gililland, MD         
Sub-Investigator: Christopher Peters, MD         
Sub-Investigator: Christopher Pelt, MD         
Sponsors and Collaborators
Zimmer Biomet
Accelero Health Partners, LLC
Investigators
Study Director: Erin Osborn, MBA, CCRP Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03737149     History of Changes
Other Study ID Numbers: CLU2018-13CH
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
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