United Orthopedic Corporation enrolled its first patient in a clinical study for the U2 Knee System.
The study, titled "Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee System—'U Propel Study'," is a prospective, single arm, multicenter post-market study. Here are five things to know:
1. The study will enroll up to 200 patients who will participate in baseline, pre-discharge, six week, three six and 12-month follow-ups. They will be followed for five years.
2. The study is focused on five-year implant survivorship, and the study is expected to last seven years.
3. Secondary endpoints in the study include Knee Society Score, radiographic success, patient satisfaction, operative characteristics and other outcomes scores.
4. The outcomes are expected to reach publication in three phases: after all enrolled patients have six-week follow-ups, two years after surgery and the conclusion of the study.
5. David Cashen, MD, of Coastal Orthopedics in Bradenton, Fla., and George Markovich, MD, of the Institute for Orthopaedic Surgery and Sports Medicine in Fort Myers, Fla., will be study investigators along with their respective teams of orthopedic surgeons.