The Center for Joint Preservation at the Rubin Institute for Advanced Orthopedics at Sinai Hospital is participating in a clinical study with Orthofix International N.V. to assess the effectiveness and safety of pulsed electromagnetic field technology (PEMF) for osteoarthritis (OA) of the knee.
The research will evaluate the potential use of a PEMF device to reduce joint inflammation of the knee, reduce the breakdown of the cartilage, stimulate the formation of new cartilage and reduce the need for surgery. The device sends a low-level pulse of electromagnetic energy to the targeted area, and researchers are looking to see if this may activate and augment the body's natural healing process.
"Millions of people live with the pain of osteoarthritis, which may force them to limit their activities. We are interested to see if a PEMF device, worn externally over the knee, may potentially modify the disease and ease symptoms, offering people a non-invasive treatment option," says Ronald Delanois, M.D., primary investigator and division director of the Center for Joint Preservation and Replacement at Sinai Hospital.
Study participants must be at least 40 years old and have been diagnosed with osteoarthritis of the knee with mild to moderate pain. Participants will wear the device around the knee for a total of three hours a day, seven days a week for one year. It does not have to be worn continuously. Follow-up appointments will be scheduled at three, six and 12 months.
The Rubin Institute for Advanced Orthopedics is one of three centers participating in the randomized, double-blind study. The other facilities are Brown University School of Medicine in Providence, Rhode Island, and the Cleveland Clinic in Cleveland, Ohio. The centers are looking to enroll 150 participants to test the PEFM device. As part of the randomization, two out of every three participants will receive active therapy, with the third receiving a placebo treatment.
Osteoarthritis is a degenerative joint disease that causes cartilage, the rubbery protein substance that acts as a cushion or shock absorber between the end of bones, to break down or deteriorate over time. It usually affects weight-bearing joints including the knees, hips, neck, thumbs, big toe and spine. Symptoms can include pain, stiffness and swelling in joints and limited range of motion.