Sam Brusco, Associate Editor02.14.24
ZKR Orthopedics has gained investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for a clinical trial to evaluate the company’s LIFT implant to treat adults with later-stage patellofemoral cartilage degeneration.
The LIFT implant elevates and realigns the patella tendon, unloading the patellofemoral compartment by reducing compressive forces and shifting patellar tracking toward healthier cartilage. The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a positioning instrument.
The PELICAN trial will enroll about 245 patients at 24 U.S. and European sites. The LIFT implant’s performance will be assessed against tibial tubercule osteotomy to treat cartilage degeneration in the patellofemoral compartment.
The trial’s primary endpoint consists of relevant patient reported outcomes, a safety evaluation, and radiographic confirmation. Both treatment arms will collect data on secondary endpoints including pain, function, and speed of recovery.
ZKR Orthopedics CEO David Cash expects the data collected from the PELICAN trial to provide compelling clinical evidence for the LIFT implant’s approval for clinical use. LIFT was granted FDA breakthrough device status in October 2023.
“I am incredibly proud of our team for accomplishing this milestone,” Cash told the press. “The IDE approval, combined with our previously obtained Breakthrough Device Designation, positions the company to increase awareness of the unmet need in the patellofemoral cartilage degeneration patient population."
ZKR’s first-in-human trial evaluated LIFT in eight patellofemoral cartilage degeneration patients enrolled in Warsaw, Poland and followed for 24 months. The data was used to support the company’s PELICAN IDE application:
The IDE approval was revealed at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting. Team members from ZKR are introducing the LIFT technology in a cadaver laboratory held at AAOS, as well.
The LIFT implant elevates and realigns the patella tendon, unloading the patellofemoral compartment by reducing compressive forces and shifting patellar tracking toward healthier cartilage. The LIFT system includes trial spacers, a PEEK implant, titanium bone screws, K-wires, and a positioning instrument.
The PELICAN trial will enroll about 245 patients at 24 U.S. and European sites. The LIFT implant’s performance will be assessed against tibial tubercule osteotomy to treat cartilage degeneration in the patellofemoral compartment.
The trial’s primary endpoint consists of relevant patient reported outcomes, a safety evaluation, and radiographic confirmation. Both treatment arms will collect data on secondary endpoints including pain, function, and speed of recovery.
ZKR Orthopedics CEO David Cash expects the data collected from the PELICAN trial to provide compelling clinical evidence for the LIFT implant’s approval for clinical use. LIFT was granted FDA breakthrough device status in October 2023.
“I am incredibly proud of our team for accomplishing this milestone,” Cash told the press. “The IDE approval, combined with our previously obtained Breakthrough Device Designation, positions the company to increase awareness of the unmet need in the patellofemoral cartilage degeneration patient population."
ZKR’s first-in-human trial evaluated LIFT in eight patellofemoral cartilage degeneration patients enrolled in Warsaw, Poland and followed for 24 months. The data was used to support the company’s PELICAN IDE application:
- Reduced pain from 68.6 at baseline to 26.2 (62%)
- Improvement in function from 55.3 at baseline to 71.0 (28%)
- No patients progressed to partial or total knee replacement
- No evidence of Patellar tendon necrosis or tendon structural damage
The IDE approval was revealed at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting. Team members from ZKR are introducing the LIFT technology in a cadaver laboratory held at AAOS, as well.