A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

Osteoarthritis, Knee Clinical Trial

Official title:

A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03737149
• Other study ID #: CLU2018-13CH
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10500
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

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.

Locations

Country	Name	City	State
Australia	National Capital Private Hospital	Canberra	Australian Capital Territory
Australia	Epworth Healthcare - Richmond	Richmond	Victoria
Italy	Policlinico Universitario Campus Bio-Medico	Roma
Netherlands	St. Annaziekenhuis	Geldrop
United States	New Mexico Orthopaedic Associates	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	OrthoBethesda	Bethesda	Maryland
United States	Rothman Institute	Bryn Mawr	Pennsylvania
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Main Campus	Cleveland	Ohio
United States	Colorado Joint Replacement	Denver	Colorado
United States	Panorama Orthopedics & Spine Center	Denver	Colorado
United States	Sah Orthopaedic Associates	Fremont	California
United States	Midwest Center for Joint Replacement	Indianapolis	Indiana
United States	Hoag Orthopedic Institute	Irvine	California
United States	Bluegrass Orthopaedics	Lexington	Kentucky
United States	Rothman Institute	Montvale	New Jersey
United States	Duke University	Morrisville	North Carolina
United States	JIS Orthopedics	New Albany	Ohio
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Orthopedic + Fracture Specialists	Portland	Oregon
United States	Stanford University	Redwood City	California
United States	Ascension Medical Group - University Orthopaedic Specialists	Rochester Hills	Michigan
United States	Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Michigan Orthopaedic Surgeons	Southfield	Michigan
United States	Foundation for Orthopedic Research and Education	Temple Terrace	Florida
United States	ROC Orthopedics	Tualatin	Oregon
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Australia,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 Days postop
Secondary	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.	90 Days
Secondary	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.	90 Days
Secondary	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.	90 Days
Secondary	Phase II RCT: Incidence of Manipulation under Anesthesia (MUA)	Comparison of incidence of Manipulation under anesthesia (MUA) between the study groups.	90 Days
Secondary	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.	90 Days
Secondary	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.	90 Days
Secondary	Phase II RCT: Subject Satisfaction	Comparison of subject satisfaction survey results between the study groups.	90 Days
Secondary	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.	90 Days