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A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03737149
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Accelero Health Partners, LLC
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE November 9, 2018
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE October 22, 2018
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Phase II RCT: Subject Satisfaction [ Time Frame: 90 Days ]
    Comparison of subject satisfaction survey results between the study groups.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Official Title  ICMJE A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Osteoarthritis, Knee
  • Osteoarthritis, Hip
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: mymobility with Apple Watch
    Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
    Intervention: Other: mymobility with Apple Watch
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 8, 2018)
10500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Subject must be 18 years of age or older.
  2. Subject qualifies for a primary, unilateral total or partial knee arthroplasty, or total hip arthroplasty based on physical exam and medical history.
  3. Investigator plans to treat subject with a Zimmer Biomet device as part of their clinical care.
  4. Subject must own and maintain an iPhone 6 or newer (excluding the iPhone SE).
  5. Subject must be willing and able to complete the protocol required follow-up.
  6. Subject must be able to read and understand the language that the mymobility app is written in for their region
  7. Subject is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent Form (ICF). 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Scott Abshagen, BS, RN, CCRP 574-371-9782 scott.abshagen@zimmerbiomet.com
Contact: Erin Osborn, MBA, CCRP 574-371-9884 Erin.Osborn@zimmerbiomet.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03737149
Other Study ID Numbers  ICMJE CLU2018-13CH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Accelero Health Partners, LLC
Investigators  ICMJE
Study Director: Erin Osborn, MBA, CCRP Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP