Global medical device company Orthofix International has initiated a trial to evaluate the use of pulsed electromagnetic field (PEMF) technology for the treatment of osteoarthritis (OA) of the knee.
Rhode Island’s Brown University professor Dr Roy Aaron has enrolled the first patient in the trial, which will evaluate the efficacy and safety of the company’s 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.
Aaron noted: “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.
“We are hopeful that active PEMF stimulation may provide us with a new non-invasive treatment approach that could help patients with knee OA avoid surgery and improve their overall quality of life.”
The prospective, randomised, double-blind and placebo-controlled feasibility trial will recruit around 150 patients aged about 40 years or older at three sites in the US.
The sites include Brown University School of Medicine in Providence, Sinai Hospital of Baltimore in Baltimore and the Cleveland Clinic in Cleveland.
The Orthofix Physio-Stim device has already received approval from the US Food and Drug Administration (FDA) to treat nonunion fractures.
According to the company, the trial participants will be randomised 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.”