What is the mymobility Clinical Study?
The mymobility Clinical Study is for qualified patients undergoing knee or hip joint replacement. In this study, Zimmer Biomet is partnering with Apple to explore the impact of pairing the mymobility app with Apple Watch activity monitoring throughout pre- and post-operative care.
How does the study work?
Patients enrolled in the mymobility Clinical Study testing group receive personalized care plans that begin before the joint replacement procedure and continue postoperatively. These patients use the mymobility app and Apple Watch to receive exercise instructions and education. Notifications on these devices remind patients to tell their care team how they are doing and feeling throughout the process. The app also enables patients to complete and submit surveys, helping them and their surgical care team to stay informed and on track throughout the recovery process.
Patients in the control group receive the standard of care and also complete and submit occasional surveys.
Why should I participate in this study?
Patients enrolled in the mymobility Clinical Study test group receive a plan designed to increase collaboration with their surgical care team throughout the pre- and post-surgery process. For example, patients may receive information to help them learn more about their condition, how to prepare for surgery, what to expect the day of surgery, steps to minimize complications after surgery, and how to regain mobility. Patients can also use the app to communicate directly with their surgical care team.
Patients in the control group can expect to receive the standard of care and to complete occasional surveys.
Data collected in the mymobility Clinical Study will generate one of the largest and most complete data sets on preparation for and recovery from joint replacements. By analyzing this information, we increase the potential to improve patient outcomes.
Who may participate?
The study is recruiting adults 18 years or older who:
- Are scheduled to have a total or partial knee replacement or total hip replacement at one of the selected clinical study sites
- Are mobile with no more than a single cane or single crutch
- Own an iPhone 6S (excluding 2016, 2017 iPhone SE) or newer.
What phone is compatible for use throughout the study?
iPhone 6S or newer (excluding 2016, 2017 iPhone SE) can be used for the study.
Do I need an Apple Watch to use for the study?
If patients enrolled in the test group do not have a compatible Apple Watch, they will receive one to use during the study. Patients in the control group do not need an Apple Watch to participate in the study.
Which Apple Watch is compatible to use in the study?
Patients in the test group may be able to use their own Apple Watch, as long as it is Series 3 or newer. Patients who do not have an Apple Watch, or one compatible for use, will receive one to use during the study.
Patients in the control group do not need an Apple Watch to participate in the study.
If I want to participate, what do I need to do first?
Patients who believe they may qualify for participation can contact one of our research sites to set up an appointment with a surgeon.
Is this going to cost me anything?
This study includes procedures or examinations normally required of patients having joint replacement surgery. The cost of standard medical treatment will be billed to the patient and/or their insurance company. Patients are responsible for any deductibles or applicable co-pays for routine office visits and x-rays.
Patients are not charged for any visits related only to the study.
Patients in the test group will be provided with an Apple Watch, if needed, for use during the study. If the patient does not undergo joint replacement surgery as planned, or leaves the study early, the watch will need to be returned.
Neither the patients nor their insurance company will have any additional financial obligations as a result of participating in the study.
How long will the study last?
Patients enrolled in the study commit to participation in this research for up to 3 months prior to their surgery and to up to 14 months after the surgery. Total participation time ranges from 13 to 17 months. Study enrollment started in October 2018 and is expected to continue into 2021.
What data will be collected?
Data collected during the study includes survey responses and data obtained by the mymobility app (using iPhone and Apple Watch) and HealthKit (if applicable). Additional information from the joint replacement surgery and associated office visits (such as medical history information, physical exam information, and complications) will also be collected. For the purpose of analyses, only coded study data (explained below) will be used.
What happens to my data?
The data gathered when using the mymobility application will go to a secure database where it will be de-identified (removing each patient’s name or other identifying information) and coded (assigned a random code to protect patient privacy). Participants’ data is then combined before being analyzed. Data may be used to inform care decisions.
Data will be confidential except where disclosure is required by law or as described in the informed consent form and authorization document. A consent form will be provided for patient review and signature prior to data collection. Patient data will be stored and transmitted using secure systems. If the results of this study are published or presented at meetings, any identifiable information will be omitted. Coded data may be submitted by the study sponsor for FDA approval of the investigational device or be shared with study collaborators (e.g. Apple) for development and improvement of health-related products.
Who will have access to my data?
The following organizations may have access to patient data: Apple Inc., Zimmer Biomet, an Institutional Review Board (ethics committee and its subsidiaries/affiliates), Data and Safety Monitoring Board, Office for Human Research Protections in the U.S. Department of Health and Human Services, the FDA (Food and Drug Administration) and other international regulatory agencies.
I cannot find a study site close to my local area; can I still use mymobility?
mymobility is available outside of the study at some facilities. To find a mymobility provider, patients may visit Find a Doc. mymobility providers are indicated with a mymobility badge, or ask their surgeon to help in the search.
Who do I contact when I have questions during the study?
The mymobility app has a built-in direct messaging feature, so patients can consult with their surgical care team—sending questions, concerns, and pictures or videos—without the need for an appointment.
What is an Institutional Review Board?
An Institutional Review Board (IRB) is an independent committee established to protect the rights of research subjects.
How does this differ from the treatment I would receive with traditional physical therapy?
Zimmer Biomet’s mymobility with Apple Watch program creates a direct and immediate connection between patients and surgeons. We designed it to optimize the patient experience for joint replacements, providing active support and guidance as patients prepare for and recover from surgery.
In what stage in my orthopedic surgery journey do I have to enroll in the program?
Patients will need to enroll in the study at least 2 weeks before their joint replacement surgery. This is because there is mymobility educational content to be reviewed and additional important study information to be collected before and during surgery. The office staff at each participating clinical study site can provide more information.
Are you 'tech savvy' enough to use mymobility?
What procedures are included in the study?
Total Knee Arthroplasty (TKA), Partial Knee Arthroplasty (PKA), and Total Hip Arthroplasty (THA).