CyMedica Orthopedics said it has launched a clinical trial to evaluate the effectiveness of its E-vive muscle-strengthening device and patient engagement system in knee osteoarthritis patients.
Researchers will combine the data generated by the E-vive neuromuscular electrical stimulation device with the activity and health data collected by commercially available wearable smartwatch devices to determine the effect of E-vive on improving patient osteoarthritis (OA) symptoms, according to Scottsdale, Ariz.-based CyMedica.
The randomized, prospective clinical trial will be conducted on 120 osteoarthritis patients in clinical collaboration with Northwell Health, New York’s largest health system.
“The E-vive clinical trial for knee osteoarthritis marks a major advancement for CyMedica in the treatment landscape for managing osteoarthritis knee pain,” said CyMedica president and CEO Rob Morocco in a news release. “It comes at a time when an overwhelming number of knee arthritis patients are in urgent need of non-narcotic, non-addictive and home-based wearable therapies to help the millions of Americans who suffer from this painful chronic condition.”
The results of a separate trial announced in March showed that the E-vive NMES and knee-replacement patient engagement system yielded statistically significant improvements. That trial, which measured 66 total-knee-replacement patients, demonstrated an earlier return to function and increase in quadriceps strength in patients treated with E-vive versus the standard of care, according to researchers at Cleveland Clinic.
The patients showed a 12.9% increase in quadriceps strength at the three-week post-operative point (a critical period of time where patients commonly experience a substantial loss of quadriceps strength, 29% loss for the standard of care patients in this trial), and increased timed-up-and-go test times at both the six- and 12-weeks post-surgery.