First Patient Enrollment in Orthofix Osteoarthritis of the Knee Study

Orthofix International N.V., a diversified, global medical device company, today announced enrollment of the first patient in a study evaluating the use of pulsed electromagnetic field (PEMF) technology for osteoarthritis (OA) of the knee. This study will assess the efficacy and safety of the Company’s Physio-Stim system in reducing inflammation and restoring homeostasis of the extracellular matrix, potentially providing symptomatic relief of OA pain, reducing cartilage breakdown, and stimulating new cartilage formation. If successful, this would be the first disease-modifying treatment for osteoarthritis. Preservation or restoration of joint structure together with reduction of inflammation would be expected to improve symptoms and reduce the need for surgical intervention.
 
The first patient in the study was enrolled by Dr. Roy Aaron, Professor at Brown University in Providence, RI. “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,” said Dr. Aaron. “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 OA of the knee study is a prospective, randomized, double-blind, placebo-controlled feasibility trial that will enroll approximately 150 patients who are 40 years of age or older at three sites in the U.S. These include Brown University School of Medicine in Providence, R.I.; Sinai Hospital of Baltimore in Baltimore, Md.; and the Cleveland Clinic in Cleveland, Ohio. Study participants will be randomized in a two-to-one ratio to either an active or placebo control (inactive) device and followed for 12 months after initiation of treatment.
 
“This study demonstrates Orthofix’s vision of developing new applications for our PEMF technology,” said James Ryaby, Ph.D., chief scientific officer for Orthofix. “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.”
 
The Orthofix Physio-Stim device is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of nonunion fractures. The device uses a low-level electromagnetic field (PEMF) that helps activate and augment the body’s natural healing process. Use in the OA study is investigational and is being conducted under an Investigational Device Exemption (IDE) from the FDA.