KENTFIELD, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) — ZKR Orthopedics, Inc. a clinical stage medical device company, today announced successful completion of two-year follow up on subjects enrolled in the first-in-human clinical trial. The 18-patient trial conducted in the European Union was designed to evaluate the safety of the LIFT implant technology on patients with varying stages of patellofemoral cartilage degeneration. Further, the trial collected data related to pain, function, and radiographic imaging to evaluate the performance of the LIFT implant as a surgical alternative.
Dr. Konrad Slynarski, the principal investigator for the trial, expressed his excitement about the results, saying, “The success of this ZKR trial provides evidence that the patella LIFT implant appears to be a safe and effective surgical alternative for patients with patellofemoral cartilage degeneration and arthritis. Overall, there was a high level of patient satisfaction and improvements in both pain and function.”
The first-in-human trial evaluated the performance of two implant geometries in a patient set which included patellofemoral cartilage degeneration ranging from moderate (Outerbridge Grade 2) to severe (bipolar osteoarthritis). A review of the data demonstrated an impressive reduction in pain (Visual Analog Scale) and improvement in function (Kujala Scale). No patients progressed to partial or total knee replacement. Additionally, there were no severe adverse events reported in the trial.
The LIFT technology developed by Dr. Jeff Halbrecht is designed to elevate and realign the patella tendon to unload the patellofemoral compartment of the knee. Dr. Halbrecht stated, “The data from the pilot trial provides further evidence to our clinical hypothesis – unloading the patellofemoral compartment with the LIFT implant improves pain and function across a wide range of patients suffering from cartilage degeneration and osteoarthritis of the knee. Based on this data, we are excited to move forward with our US pivotal trial to further confirm the safety and efficacy of the technology.”
In conjunction with its regulatory and clinical advisors, ZKR is preparing the application for its pivotal trial which shall be conducted under an Investigational Device Exemption. The trial will evaluate the performance of the LIFT implant technology compared to tibial tubercle osteotomy in patients aged 25-65 with cartilage degeneration and osteoarthritis of the patellofemoral compartment of the knee.
ZKR Orthopedics is a leading innovator for treating patellofemoral disease. The Company’s mission is to extend the life of the native knee joint through innovative and durable surgical solutions.
For media inquiries or additional information, please contact:
ZKR Orthopedics, Inc.
info@zkrorthopedics.com
