An FDA cleared smartwatch-based knee OA device is the subject of a new randomized, prospective clinical trial will be conducted on 120 osteoarthritis patients in collaboration with Northwell Health, New York’s largest health system.
The system, named e-vive™, is an award-winning digital wearable, app-based muscle activation and patient engagement system designed to deliver muscle stimulation therapy while ALSO connecting patients with their healthcare providers in real time.
The manufacturer is CyMedica Orthopedics®, Inc., a Scottsdale, Arizona-based medical technology company.
According to the company, this clinical study will evaluate the effectiveness of its muscle-strengthening device, e-vive, that uses smartwatch technology to collect health data on its users.
The study will be led by researchers Matthew Stewart Hepinstall, M.D., and Michael A. Mont, M.D., vice president of Strategic Operations in Orthopedics at Northwell Health.
Researchers will combine the muscle strengthening e-vive data with the activity and health data collected by wearable smartwatch devices to determine the effect of this technology on improving patient osteoarthritis (OA) symptoms.
Muscle weakness is a common clinical condition associated with knee osteoarthritis. Dr. Mont explained that “The success of the e-vive quadriceps muscle-strengthening in post-surgical knee rehabilitation has been well documented….Through this clinical trial, CyMedica and Northwell Health have a unique opportunity to positively measure the effectiveness of e-vive muscle strengthening using a novel, app-based patient-engagement system and smartwatch technology, which patients are already wearing. In turn, patients are able to better manage their symptoms earlier in their knee osteoarthritis journey.”
Bryti Ketchum, vice president of Marketing for CyMedica told OTW, “The launch of the e-vive clinical trial for knee osteoarthritis marks another significant milestone in strategic vision for CyMedica Orthopedics. This clinical trial is designed primarily to capture the reduction of knee pain from utilizing e-vive as a non-drug, non-invasive solution.”
Ketchum continued, “The initiation of this randomized controlled clinical trial follows the recent positive results from the clinical trial at Cleveland Clinic, proving e-vive is an effective solution for regaining quadriceps strength and function in total knee replacement patients. By pairing this positive data with the highest patient engagement levels of all app-driven medical devices, e-vive is offering an entirely new treatment method for the growing joint disease population.”
