Orthofix announces initiation of enrollment in rotator cuff repair study
Orthofix International announced that enrollment has begun in a study that will evaluate the use of pulsed electromagnetic field technology for rotator cuff repair. This study will assess the efficacy and safety of the Company's RCStim device as an adjunctive treatment to surgical repair of full thickness rotator cuff tears. The study will evaluate if PEMF technology that is currently used to promote bone growth can reduce the rate of repaired tendons being subsequently torn again and improve overall patient outcomes. The study will also gather data to see if there is a correlation between patients treated with PEMF and improvements in muscle strength and range of motion and a decrease in pain scores. The PEMF study for rotator cuff repair is a prospective, randomized, double-blind, placebo-controlled trial that will enroll approximately 538 patients who are between 21 and 80 years of age at up to 30 sites in the U.S. Study participants will be randomized in a two-to-one ratio to either an active or placebo control device and followed for 24 months after initiation of treatment. The Orthofix RCStim device is an investigational device and use in the study is being conducted under an Investigational Device Exemption from the U.S. Food and Drug Administration.