The Lewisville, Texas-based company said the study aims to explore the efficacy and safety of its Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix to potentially provide symptomatic relief of osteoarthritis pain and stimulate new cartilage formation.
The 1st patient in the study was enrolled by Dr. Roy Aaron, Professor at Brown University in Providence, RI.
“This study demonstrates Orthofix’s vision of developing new applications for our PEMF technology. We are proud to conduct research studies like these in order to find solutions for patients who live with disabling diseases and conditions such as OA,” chief scientific officer James Ryaby said in a press release.
The prospective, randomized trial is slated to enroll 150 patients at 3 U.S. sites to examine the use of the device in patients over 12 months after initiation of the treatment.
“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,” Dr. Roy Aaron of Brown University, who enrolled the 1st patient in the study, said in prepared remarks.
In July, Orthofix said it won regulatory approval from the Japanese Ministry of Health, Labor and Wellfare for its Phoenix minimally invasive spinal fixation system.
The Phoenix system allows for the percutaneous placement of pedicle screws designed to provide stabilization and correction for spinal fusion patients suffering from degenerative disc disease and other conditions, the company said.