FDA Trial for New Patella LIFT Procedure

Medically reviewed by Dr. Sabrina Strickland, MD · Orthopedic Surgeon, Hospital for Special Surgery · Last reviewed: January 9, 2025

January 9, 2025

Quick Summary

ZKR Orthopedics' Patella LIFT is a minimally invasive implant designed to unload the kneecap in patients with patellofemoral cartilage wear or arthritis. The FDA PELICAN trial compares it against tibial tubercle osteotomy. The procedure allows immediate weight-bearing — a meaningful advantage over osteotomy's six-week crutch recovery. Hospital for Special Surgery plans to participate.

This new Patella LIFT implant from ZKR Orthopedics is exciting as it may alleviate pain in patients suffering from anterior knee pain due to patellofemoral cartilage wear or arthritis. I first heard of this implant from its designer, Jeff Halbrecht, MD, at the International Patellofemoral Study Group.

According to the press release, the PELICAN study will assess patients with advanced cartilage degeneration and osteoarthritis in the patellofemoral joint. It will compare outcomes of the ZKR Patella LIFT Implant, performed at U.S. centers, against a control group of tibial tubercle osteotomies performed at European centers. The trial’s primary endpoints include patient-reported outcomes, safety, and radiographic confirmation, while the secondary endpoints will focus on pain, function, and recovery speed.

The Patella LIFT implant can be placed relatively quickly, and the patient can bear weight immediately, which is a huge advantage over current techniques. We plan to participate in this clinical trial and are optimistic that it may help patients currently unable or unwilling to spend six weeks on crutches after an osteotomy. As with any investigational device, candidacy and outcomes will vary based on the degree of cartilage damage, joint alignment, and individual anatomy — eligibility for the trial is determined on a case-by-case basis.

Read more about the study in the ZKR Orthopedics press release.

Photo by Anna Auza on Unsplash

Frequently Asked Questions

What problem is the Patella LIFT implant designed to address?

The Patella LIFT, developed by ZKR Orthopedics, is designed for patients with front-of-knee pain from cartilage wear or arthritis behind the kneecap. The implant mechanically takes pressure off the kneecap. It is being studied as an alternative to a tibial tubercle osteotomy (a procedure that moves the bony bump on the front of the shinbone where the kneecap tendon attaches) in selected candidates, with the goal of relieving pain without the recovery burden of a bony procedure.

How does Patella LIFT compare to a tibial tubercle osteotomy?

The biggest difference for patients is recovery time. After a tibial tubercle osteotomy, patients are usually on crutches for around six weeks while the bone heals. With the Patella LIFT implant, you can put weight on the leg right away. Whether the long-term outcomes are equivalent will be answered by the PELICAN trial — the main measures include patient-reported outcomes, safety, and confirmation on imaging.

Will Hospital for Special Surgery participate in the PELICAN trial?

Yes — we plan to participate. PELICAN is enrolling patients with advanced cartilage wear or arthritis behind the kneecap. Eligibility is decided case by case, based on the degree of cartilage damage, the alignment of the knee, and individual anatomy. As with any investigational device, candidacy and outcomes vary, and a clinical trial is the right setting until the implant is more broadly approved.

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Medical Disclaimer. This content is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified physician regarding any questions about your orthopedic health. Individual results may vary based on diagnosis, anatomy, and overall health.