The company recruited first patient in a study, which will evaluate the efficacy and safety of its Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix.
The system will offer symptomatic relief of OA pain, reduce cartilage breakdown and stimulate new cartilage formation.
Rhode Island’s Brown University professor Roy Aaron has enrolled the first patient in the study.
Aaron said: "Finding new solutions for OA of the knee is important as these patients not only suffer from pain, they often have a high level of disability from the disease and often seek costly surgical solutions.”
The OA of the knee study is a prospective, randomized, double-blind and placebo-controlled feasibility trial, which will recruit around 150 patients aged about 40 years or older at three sites in the US.
The sited include Brown University School of Medicine in
Orthofix Physio-Stim device already received approval from the US Food and Drug Administration (FDA) to treat nonunion fractures.
According to Orthofix, the trial participants will be randomized in a two-to-one ratio to either an active or placebo control (inactive) device and followed for one year after initiation of treatment.
Orthofix chief scientific officer James Ryaby said: "This study demonstrates Orthofix's vision of developing new applications for our PEMF technology.”
Image: Osteoarthritis of the left knee. Photo: courtesy of James Heilman, MD.
