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

Tracking Information

• First Submitted Date: October 26, 2018
• First Posted Date: November 9, 2018
• Last Update Posted Date: May 26, 2023
• Actual Study Start Date: October 22, 2018
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
• Official Title: 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 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 8, 2018): 10500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Italy, Netherlands, United States

Administrative Information

• NCT Number: NCT03737149
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Zimmer Biomet
• Original Responsible Party: Same as current
• Current Study Sponsor: Zimmer Biomet
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Erin Osborn; Zimmer Biomet

• PRS Account: Zimmer Biomet
• Verification Date: May 2023