The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) to ZKR Orthopedics to begin a pivotal trial evaluating its implant for later-stage patellofemoral cartilage degeneration treatment.
The US company has designed an implant that elevates and realigns the patella tendon by decreasing compressive forces. The device is positioned using a minimally invasive procedure in an outpatient setting.
The PELICAN multicentre clinical trial is estimated to enrol around 245 patients across 24 sites in the US. Patients suffering from later-stage cartilage degeneration of the patellofemoral compartment of the knee will be implanted with the LIFT device and compared against a control group. Patients in the control group will undergo a tibial tubercle osteotomy – the current standard of care to treat the condition.
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.
ZKR Orthopedics’ CEO David Cash said: “We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use.”
ZKR Orthopedics has already conducted its first-in-human trial, the results of which helped with the IDE approval. The company reported improvements in pain and function from the trial, with none of the 18 implanted patients progressing to partial or total knee replacement. Patients were followed for a total of two years after intervention.
In December 2023, ZKR Orthopedics received FDA breakthrough device designation for the LIFT implant. The programme is designed to expedite the development and review of a device that provides more effective treatment than the options currently available.
Patellofemoral cartilage degeneration is a common condition that affects approximately seven million Americans. It is suggested that up to a third of knee arthritis originates in the patellofemoral compartment.
A market model by GlobalData calculates the cartilage repair device market was worth $76.3m in 2023. This is forecast to grow slightly to $83.5m by 2033. The knee replacement device market, on the other hand, is estimated to grow to a staggering $12.4bn by the same year.
Also in the knee cartilage repair implant market is Orthox’s FibroFix. Orthox’s clinical trial is backed by the National Institute for Health and Care Research (NIHR). Sparta Biomedical’s Ormi device, which mimics native cartilage, also received FDA breakthrough device designation.
