Taiwan Based UOC: First in Man for Knee System
Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, May 31st, 2017
It could be the beginning of something exciting for United Orthopedic Corporation (UOC)!
The company has just launched a primary total knee arthroplasty (TKA) trial and enrolled its first patient. The study, "Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee System—'U Propel Study,’” is a prospective, single arm, multicenter, study that will evaluate the short- and long-term clinical performance, and implant survivorship of UOC’s U2 Knee System in primary TKA patients.
"We were extremely confident with the execution and success of the first U2 Knee System replacement," said David Cashen, M.D., principal study investigator and practicing orthopedic surgeon at Coastal Orthopedics in Bradenton, Florida, in the May 23, 2017 news release. "One day after surgery our patient is ambulating independently, performing a straight leg raise and confidant to return home with only mild discomfort. We look forward to monitoring her recovery through our research."
Up to 200 patients will be enrolled in the study, which will measure patients and the implant based on baseline, pre-discharge, six-week, three, six and 12-month, as well as annual follow-up visits for up to five years. The study's primary endpoint is implant survivorship.
"For more than two decades, our company has been engaged in helping orthopedic surgeons deliver high-quality care to their patients, providing them with innovative products designed to improve patient health and satisfaction," said Calvin Lin, President of United Orthopedic Corporation USA. "The U-Propel study underscores our continued commitment to orthopedic care, building upon our foundation of research that demonstrates the value of our solutions."
George Markovich, M.D., an orthopedic surgeon and study investigator and a member of the Institute for Orthopaedic Surgery and Sports Medicine in Fort Myers, Florida, tells OTW, “The U–Propel research study allows us to bring the U2 Knee System to Coastal orthopedics and to actively observe patient performance and satisfaction through extensive patient follow-up appointments and by collecting detailed patient reported outcome measures. We are excited to offer this knee replacement system to our patients with the added benefit of measuring our success over a five year period.”
“The meticulous organizational skills and required diligence from our clinical research staff to ensure appropriate follow-up compliance will be the biggest challenge of this research study. Initially, we experienced challenges of introducing the U2 Knee system as a new vendor to our local area hospitals. However, we are poised now to successfully move this endeavor forward.”