United Orthopedic Corp. said today it launched a new trial of its U2 total knee arthroplasty system and has enrolled the 1st patient in the trial.
In the study, the Irvine, Calif.-based company will examine short and long term clinical performance and implant survivorship in patients undergoing TKA procedures with its U2 unit.
“We were extremely confident with the execution and success of the first U2 Knee System replacement. 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,” principal investigator Dr. David Cashen of Bradenton, Fla.’s Coastal Orthopedics said in a prepared statement.
The 200-patient, 7-year study will collect baseline patient data, as well as pre-discharge, with follow ups at 6 weeks, 3 months, 6 months and 12 months, the company said. The study will also include annual follow up visits for up to 5 years.
The trial’s primary endpoint is implant survivorship, with secondary endpoints including Knee Society Scores, radiographic success, subject satisfaction, operative characteristics, KOOS, Jr. and EQ-5D, the company said. Outcomes will be will be analyzed in 3 phases, including 6-weeks, 2-years and at the study’s completion.
“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. The U-Propel study underscores our continued commitment to orthopedic care, building upon our foundation of research that demonstrates the value of our solutions,” prez Calvin Lin said in a press release.