A Prospective Multicenter Longitudinal Cohort Study of the Mymobility Platform

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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, 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03737149
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Erin Osborn, MBA, CCRP
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOther
Overall Status Recruiting
Countries Australia, Netherlands, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee, Osteoarthritis, Hip
Additional Details

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.

Arms & Interventions

Arms

Experimental: mymobility with Apple Watch

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

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sah Orthopaedic Associates, Fremont, California

Status

Recruiting

Address

Sah Orthopaedic Associates

Fremont, California, 94538

Site Contact

Marie Sabado-Bell

[email protected]

510-818-7284

Hoag Orthopedic Institute, Irvine, California

Status

Recruiting

Address

Hoag Orthopedic Institute

Irvine, California, 92618

Site Contact

Marie-Claire Fickenscher

[email protected]

949-255-9753

Stanford University, Redwood City, California

Status

Recruiting

Address

Stanford University

Redwood City, California, 94063

Site Contact

Angela Bye, MA, ATC

[email protected]

650-721-7632

Colorado Joint Replacement, Denver, Colorado

Status

Recruiting

Address

Colorado Joint Replacement

Denver, Colorado, 80210

Site Contact

Rose Johnson, CCRP

[email protected]

303-260-2940

Panorama Orthopedics & Spine Center, Denver, Colorado

Status

Recruiting

Address

Panorama Orthopedics & Spine Center

Denver, Colorado, 80401

Site Contact

Panorama Orthopedics & Spine Center

[email protected]

303-233-1223

Temple Terrace, Florida

Status

Recruiting

Address

Foundation for Orthopedic Research and Education

Temple Terrace, Florida, 33637

Site Contact

Katheryne Downes, PhD, MPH

[email protected]

813-978-9700 #6881

Cleveland Clinic Florida, Weston, Florida

Status

Not yet recruiting

Address

Cleveland Clinic Florida

Weston, Florida, 33331

Site Contact

Alison Klika

[email protected]

216-444-4954

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30329

Site Contact

Anjali Kumar

[email protected]

404-444-5915

Rush University Medical Center, Chicago, Illinois

Status

Active, not recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Midwest Center for Joint Replacement, Indianapolis, Indiana

Status

Recruiting

Address

Midwest Center for Joint Replacement

Indianapolis, Indiana, 46241

Site Contact

Haley Schwartz

[email protected]

317-455-1064

Bluegrass Orthopaedics, Lexington, Kentucky

Status

Recruiting

Address

Bluegrass Orthopaedics

Lexington, Kentucky, 40509

Site Contact

Daniel Wicker

[email protected]

859-263-5140 #643

OrthoBethesda, Bethesda, Maryland

Status

Recruiting

Address

OrthoBethesda

Bethesda, Maryland, 20817

Site Contact

Nila Parvizian

[email protected]

301-580-7798

Newton-Wellesley Hospital, Newton, Massachusetts

Status

Recruiting

Address

Newton-Wellesley Hospital

Newton, Massachusetts, 02462

Site Contact

Maureen Dwyer, PhD, ATC

[email protected]

617-243-6493

DeClaire LaMacchia Orthopaedic Institute, Rochester Hills, Michigan

Status

Recruiting

Address

DeClaire LaMacchia Orthopaedic Institute

Rochester Hills, Michigan, 48307

Site Contact

Katie Mabee

[email protected]

248-609-9137

Michigan Orthopaedic Surgeons, Southfield, Michigan

Status

Not yet recruiting

Address

Michigan Orthopaedic Surgeons

Southfield, Michigan, 48075

Site Contact

Nevena Corrie

[email protected]

248-845-4378

Rothman Institute, Rutherford, New Jersey

Status

Recruiting

Address

Rothman Institute

Rutherford, New Jersey, 07070

Site Contact

Tiffany Morrison

[email protected]

267-339-7818

New Mexico Orthopaedic Associates, PC, Albuquerque, New Mexico

Status

Recruiting

Address

New Mexico Orthopaedic Associates, PC

Albuquerque, New Mexico, 87110

Site Contact

Natalie Munson

[email protected]

505-239-3174

Duke University, Durham, North Carolina

Status

Recruiting

Address

Duke University

Durham, North Carolina, 22703

Site Contact

Jennifer Friend

[email protected]

919-668-4373

Cleveland Clinic Main Campus, Cleveland, Ohio

Status

Not yet recruiting

Address

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195

Site Contact

Kelsey Girbino

[email protected]

216-445-8023

JIS Orthopedics, New Albany, Ohio

Status

Recruiting

Address

JIS Orthopedics

New Albany, Ohio, 43054

Site Contact

Michael Sneller

[email protected]

614-221-6331 #347

Orthopedic + Fracture Specialists, Portland, Oregon

Status

Recruiting

Address

Orthopedic + Fracture Specialists

Portland, Oregon, 97225

Site Contact

Erin Zimmerman

[email protected]

503-214-5259

ROC Orthopedics, Tualatin, Oregon

Status

Recruiting

Address

ROC Orthopedics

Tualatin, Oregon, 97062

Site Contact

Annette Vo-Tran

[email protected]

503-213-1658

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Annamarie Horan, MPA, PhD

[email protected]

215-294-9132

Rothman Institute, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Rothman Institute

Philadelphia, Pennsylvania, 19107

Site Contact

Tiffany Morrison

[email protected]

267-339-7818

University of Utah, Salt Lake City, Utah

Status

Recruiting

Address

University of Utah

Salt Lake City, Utah, 84108

Site Contact

Gabriella Cabrera-Brown, MSc, BScPT

[email protected]

801-587-7146

International Sites

National Capital Private Hospital, Canberra, Australian Capital Territory, Australia

Status

Recruiting

Address

National Capital Private Hospital

Canberra, Australian Capital Territory, 2605

Site Contact

Ricardo Torres

[email protected]

+61 2 6225 7410

Epworth Healthcare - Richmond, Richmond, Victoria, Australia

Status

Recruiting

Address

Epworth Healthcare - Richmond

Richmond, Victoria, 3121

Site Contact

Stasie Abela

[email protected]

+61 3 9936 8205

St. Annaziekenhuis, Geldrop, Netherlands

Status

Not yet recruiting

Address

St. Annaziekenhuis

Geldrop, ,

Site Contact

Walter van der Weegen

[email protected]

+31 40 2864 280