Study to Evaluate Clinical Performance of the System in Primary Total Knee Arthroplasty
IRVINE, Calif., May 23, 2017 – United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced the launch of a primary total knee arthroplasty (TKA) trial. Entitled “Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System – ‘U Propel Study’,” the trial recently enrolled its first patient. This prospective, single arm, multi-center, post-market study will evaluate the short- and long-term clinical performance, and implant survivorship of the commercially available U2 Knee™ System in subjects receiving primary TKA.
“We were extremely confident with the execution and success of the first U2 Knee System replacement,” said David Cashen, MD, principal study investigator and practicing orthopedic surgeon at Coastal Orthopedics in Bradenton, Fla. “One day after surgery our patient is ambulating independently, performing a straight leg raise and confident to return home with only mild discomfort. We look forward to monitoring her recovery through our research.”
The U-Propel study will enroll up to 200 patients. Patients will participate in 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. The secondary endpoints are Knee Society Score; radiographic success; subject satisfaction; KOOS, Jr.; EQ-5D and operative characteristics. The expected duration of the study is seven years.
“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.”
Outcomes from the U-Propel study will be analyzed and published in three phases as follows: after all enrolled patients have completed their six-week follow-up; at the two-year follow-up mark; and at the conclusion of the study. In addition to Dr. Cashen and the team of surgeons at Coastal Orthopedics, George Markovich, MD, is also an orthopedic surgeon and study investigator. Dr. Markovich is from the Institute for Orthopaedic Surgery and Sports Medicine in Fort Myers, Fla.
Osteoarthritis is a common disease of the aging demographic and a leading cause of disability, with the incidence of knee osteoarthritis rising with the increasing average age of the general population.1 Approximately 10 percent of people aged over 55 years have painful disabling knee osteoarthritis, of whom one quarter are severely disabled.1 TKA is one of the treatment options available to sufferers of knee osteoarthritis.
For more information about the U-Propel study, visit: https://clinicaltrials.gov/ct2/show/study/NCT03060057
UOC is actively recruiting qualified surgeons and their institutions who would like to participate in this post-market study. Please contact Mindy Carlson, Director of Clinical Research, at firstname.lastname@example.org, or 612-562-0060, to inquire.
About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. UOC’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.
1 Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian Journal of Internal Medicine. 2011;2(2):205-212.