ZKR Orthopedics’ PELICAN Trial Underway

ZKR Orthopedics Inc. has kicked off its U.S. Food and Drug Administration (FDA)-approved PELICAN trial with the first U.S. Patella LIFT procedure. 

The outpatient surgery was performed by Dr. Dennis C. Crawford, professor of Orthopedics at Oregon Health and Science University in Portland. “The procedure went very smoothly, took under 45 minutes and the patient was able to begin weight bearing and motion immediately,” Dr. Crawford said. “This patient is a 41-year-old woman who has been suffering for many years from painful arthritis behind her patella. This new procedure marks a significant advancement in orthopedic care.”

ZKR Orthopedics’ Patella LIFT procedure offers a minimally invasive method to unload the patella and relieve pain without the complications associated with other treatments. The procedure immediately restores range of motion and weight bearing, thus allowing patients to quickly return to their normal activities.

“This is an exciting moment,” ZKR Orthopedics CEO Jeffrey Halbrecht, M.D., stated. “Finally, patients with knee pain from patellofemoral arthritis and chondromalacia of the patella have a new treatment option that avoids more complex surgeries such as a tibial tubercle osteotomy or knee replacement.” 

The ZKR Orthopedics Patella LIFT procedure is less invasive and less expensive than existing options, which makes the procedure attractive to ambulatory surgery centers and payers.

ZKR received FDA approval in February for its Investigational Device Exemption trial based on a successful European pilot study performed by Dr. Konrad Slynarski in Warsaw, Poland. That two-year study on 18 patients demonstrated significant improvement in pain and function, particularly in stair climbing, squatting, and walking. Additionally, patients successfully resumed sports after the ZKR implant, including tennis, mountain biking, skiing, and hiking.

The PELICAN study will evaluate patients with later-stage cartilage degeneration and patellofemoral joint osteoarthritis. The study will compare results of the ZKR Patella LIFT implant performed in the United States to a control group consisting of tibial tubercle osteotomy procedures performed in Europe. The trial’s primary endpoints consist of patient-reported outcomes, safety measures, and radiographic confirmation. Pain, function, and speed of recovery will make up the secondary endpoints.

OHSU is the first of four sites that will be enrolling patients in the first phase of this trial. Other planned sites include The Ohio State University in Columbus; Alta Orthopedics in Santa Barbara, Calif.; and Horizon Clinical Research in San Diego. Ultimately there will be 10 U.S. investigational sites and 10 in Europe.