Orthofix (NSDQ:OFIX) said today it launched a study looking to evaluate the use of pulsed electromagnetic field technology with the company’s RCStim device as adjunctive treatment to the surgical repair of rotator cuff tears.
The 538-patient study, which has begun enrollment, will evaluate the safety and effectiveness of PEMF technology designed to promote bone growth and whether it can reduce the rate of repaired tendons being subsequently torn, as well as overall improvement in patient outcomes.
“Arthroscopic repair of rotator cuff tears can improve pain and functional use of the shoulder but a continuing challenge is the high retear rates after repair. If PEMF therapy can prove effective in improving the patient’s ability to heal after repair surgery, this could provide us with a way to lower the number of revision surgeries and improve overall outcomes,” study investigator Dr. Andrew Kuntz of the University of Pennsylvania in Philadelphia said in a prepared statement.
The Lewisville, Texas-based company said it will also use the trial to see if there is a correlation between patients treated with the RCStim device and improvements in muscle strength and range of motion and a decrease in pain.
“PEMF technology has been used for many years to promote bone growth and the healing of nonunion fractures. The rotator cuff clinical trial is based on our compelling pre-clinical research and it is our second ongoing study evaluating PEMF therapy for a soft tissue application. As we previously announced, we also have a study for Osteoarthritis of the Knee for providing symptomatic relief of OA pain, reducing cartilage breakdown and stimulating new cartilage formation. Ultimately, if results of these studies are positive, it could open the door to important new applications of this technology,” chief scientific officer James Ryaby said in a press release.