United Orthopedic Corporation (UOC) has announced the launch and first patient enrollment in a primary total knee arthroplasty (TKA) trial.
Background
UOC describes itself as a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments. The company sells clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff.
This newly announced 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.
Tagged “U-Propel” the 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. Its 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.
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.
Investigator comments
“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.”
Company comments
“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.”
Source: PR Newswire
published: May 23, 2017 in: Clinical Studies/Trials, Knee