15 Oct. 2018. Early results from a clinical trial show a virtual rehabilitation program for people with total knee replacement surgery works as well as conventional rehab methods, but at a lower cost. More results from the trial, conducted by Duke Clinical Research Institute in Durham, North Carolina and the system’s developer Reflexion Health in San Diego, will be presented next month at the annual meeting of American Association of Hip and Knee Surgeons in Dallas.
Reflexion’s main product is called Vera, short for Virtual Exercise Rehabilitation Assistant for people to perform physical therapy at home. Vera provides an online avatar to lead exercises, as well as monitor the individual’s progress in real time and provide coaching and educational materials to help achieve recovery goals. Vera also acts as a telemedicine station for remote monitoring by physicians and physical therapists. FDA cleared the Vera system in November 2015 for marketing in the U.S.
Duke Clinical Research Institute cites data from CDC showing some 700,000 total knee replacements are performed each year, with that number expected to grow to 3.5 million procedures by 2030, according to American Academy of Orthopedic Surgeons. The academy says nearly half of adults in the U.S. will develop osteoarthritis, a leading reason for the procedure, in at least one knee during their lifetimes. In addition, half of the patients receiving total knee replacements are under the age of 65, and more than 6 in 10 recipients (63%) are women, according to data from 2008. In 2016, average Medicare expenditures for surgery, hospitalization, and recovery ranged from $16,500 to $33,000 across geographic areas.
The clinical trial tested the Vera system, combined with home care planning and remote support, against conventional home and outpatient physical therapy. The study team from Duke and Reflexion enrolled 306 participants scheduled for total knee replacement surgery at 4 sites in North Carolina, with participants randomly assigned to receive virtual or conventional rehab. Of the 287 participants completing the trial, 143 performed their rehab with the Vera system, while 144 received conventional rehab therapy, with their progress tracked for 90 days.
The study team set the cost of care for 90 days as the main comparison measure between the two methods, with participants using the Vera system with clinical oversight costing $2,745 less on average than individuals receiving conventional physical therapy. Reflexion and Duke say participants using the Vera system were as likely to recover from their surgery after 90 days as well as those receiving conventional rehab, and reported similar safety profiles.
“Physical therapy is a critical component of recovery for patients following total joint replacement surgery,” says Janet Prvu Bettger, professor of orthopedic surgery at Duke and the study team leader, in a university-company statement. “As people live longer and these surgeries become more common, it is important to identify solutions that maintain or improve outcomes while decreasing the burden on patients and providers.” She notes that “Reflexion Health’s Vera coupled with remote clinician oversight is a cost-effective paradigm for physical therapy, one that is more convenient for patients while providing clinicians greater insight into the recovery process.”
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