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A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Hip

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
mymobility with Apple Watch
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring Knee Replacement, Knee Arthroplasty, Hip Replacement, Hip Arthroplasty, Joint Replacement, Physical Therapy, Partial Knee Replacement, Hip Pain, Chronic, Knee Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sah Orthopaedic Associates
  • Hoag Orthopedic Institute
  • Stanford University
  • Colorado Joint Replacement
  • Panorama Orthopedics & Spine Center
  • Foundation for Orthopedic Research and Education
  • Cleveland Clinic Florida
  • Emory University
  • Rush University Medical Center
  • Midwest Center for Joint Replacement
  • Bluegrass Orthopaedics
  • OrthoBethesda
  • Newton-Wellesley Hospital
  • Ascension Medical Group - University Orthopaedic Specialists
  • Michigan Orthopaedic Surgeons
  • Washington University
  • Rothman Institute
  • New Mexico Orthopaedic Associates
  • Duke University
  • Cleveland Clinic Main Campus
  • JIS Orthopedics
  • Orthopedic + Fracture Specialists
  • ROC Orthopedics
  • Rothman Institute
  • University of Pennsylvania
  • University of Utah
  • National Capital Private Hospital
  • Epworth Healthcare - Richmond
  • Policlinico Universitario Campus Bio-Medico
  • St. Annaziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mymobility with Apple Watch

Standard of Care Physical Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Phase II (RCT): Readmission Rate
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

Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR)
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)
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
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)
Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
Phase II RCT: Timed Up and Go (TUG)
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
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
Comparison of subject satisfaction survey results between the study groups.
Phase II RCT: Healthcare Costs
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.

Full Information

First Posted
October 26, 2018
Last Updated
October 2, 2023
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT03737149
Brief Title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Official Title
A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
10500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mymobility with Apple Watch
Arm Type
Experimental
Arm Description
Post-operative mobile application-guided education and exercise paired with accurate and sensitive activity monitoring.
Arm Title
Standard of Care Physical Therapy
Arm Type
No Intervention
Arm Description
Standard of care patient education and post-operative physical therapy, as determined by local site guidelines and care pathways.
Intervention Type
Other
Intervention Name(s)
mymobility with Apple Watch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phase II (RCT): Readmission Rate
Description
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.
Time Frame
30 Days postop
Secondary Outcome Measure Information:
Title
Phase II RCT: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS, JR)
Description
The KOOS, JR score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Time Frame
90 Days
Title
Phase II RCT: Hip disability and Osteoarthritis Outcome Score - Joint Replacement (HOOS, JR)
Description
The HOOS, JR score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.
Time Frame
90 Days
Title
Phase II RCT: EQ-5D-5L
Description
Non-inferiority in post-operative EQ-5D-5L outcomes for the mymobility with Apple Watch group compared to subjects receiving standard physical therapy.
Time Frame
90 Days
Title
Phase II RCT: Incidence of Manipulation under Anesthesia (MUA)
Description
Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.
Time Frame
90 Days
Title
Phase II RCT: Timed Up and Go (TUG)
Description
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.
Time Frame
90 Days
Title
Phase II RCT: Single-Leg Stance (SLS) Test
Description
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.
Time Frame
90 Days
Title
Phase II RCT: Subject Satisfaction
Description
Comparison of subject satisfaction survey results between the study groups.
Time Frame
90 Days
Title
Phase II RCT: Healthcare Costs
Description
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.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Osborn
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Sah Orthopaedic Associates
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Hoag Orthopedic Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Panorama Orthopedics & Spine Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Foundation for Orthopedic Research and Education
City
Temple Terrace
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Center for Joint Replacement
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46241
Country
United States
Facility Name
Bluegrass Orthopaedics
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
OrthoBethesda
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Ascension Medical Group - University Orthopaedic Specialists
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Michigan Orthopaedic Surgeons
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rothman Institute
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
New Mexico Orthopaedic Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87110
Country
United States
Facility Name
Duke University
City
Morrisville
State/Province
North Carolina
ZIP/Postal Code
27560
Country
United States
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
JIS Orthopedics
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Orthopedic + Fracture Specialists
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
ROC Orthopedics
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Rothman Institute
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
National Capital Private Hospital
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Epworth Healthcare - Richmond
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Policlinico Universitario Campus Bio-Medico
City
Roma
Country
Italy
Facility Name
St. Annaziekenhuis
City
Geldrop
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

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