The procedure initiates the FDA’s Pelican clinic trial, according to a Sept. 24 news release. The procedure took under 45 minutes and the patient began bearing weight immediately.
The patella lift procedure offers a minimally invasive method to unload the patella and relieve pain without the complications associated with other treatments.
It is both a less invasive and a less expensive treatment option that can be performed in the ASC setting.
ZKR received FDA approval in February 2024 for its investigational device exemption trial based on a successful European Pilot study.
The 18-patient study saw improvement in pain and function, particularly in stair climbing, squatting and walking for trial patients.
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.
Eventually, there will be a total of 10 investigational sites in the U.S.
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