Apple and Zimmer Biomet have begun collaborating on a large clinical study that will use an Apple Watch and iPhone app to help prepare and track patients through hip and knee replacement surgeries—with the goal of adding digital health products and active engagement to a new standard of care.

The multiyear trial, which aims to enroll as many as 10,000 participants, will study Zimmer Biomet’s mymobility app and its impacts on recovery and overall costs, by combining patient-reported feedback with heart rate and movement data collected both pre- and postsurgery.

In a statement, Zimmer Biomet President and CEO Bryan Hanson described the project as “one of the largest evidence-gathering clinical studies in orthopedic history.” The company estimates that more than 1 million knee and hip replacements are performed each year in the U.S., with that number expected to more than triple in the next two decades.
The app will remind patients to complete their assigned exercises and deliver educational guidance directly from the watch, with content chosen and prescribed by their surgeon.

In addition, a HIPAA-secure messaging client will allow providers to send texts, pictures or videos to patients to check up on their progress, or answer questions without scheduling an appointment.

“We believe one of the best ways to empower consumers is by giving them the ability to use their health and activity information to improve their own care,” said Jeff Williams, Apple’s chief operating officer.

“We are proud to enable knee and hip replacement patients to use their own data and share it with their doctors seamlessly, so that they can participate in their care and recovery in a way not previously possible through traditional in-person visits,” Williams said.

Apple made its first official hardware debut in the healthcare space last month, when it unveiled its latest version of the Apple Watch with a built-in electrocardiogram. The Series 4 model’s ECG app received de novo clearance from the FDA and was designated a Class II device.

The watch measures heart rhythms in 30 seconds by sending electric currents up one arm and down the other, through the chest to the opposite hand when in contact with the watch’s crown. All its recorded data are stored in a PDF that can be shared with physicians.

It also uses an accelerometer and gyroscope detect hard falls by analyzing wrist trajectory and impact.

After a fall, the watch sends the user an alert that can be used to call for help. If the watch senses no motion for 60 seconds after the fall, it will automatically call emergency services and notify emergency contacts with its location.

As its first main foray into the healthcare market, Apple’s inclusions of fall detection and ECG support—and now its applications in joint replacement surgery and rehabilitation—appear to be targeting an older set of potential users, instead of simply portraying the device as a must-have for tech-focused younger generations.

credit: fiercebiotech