Orthofix commenced enrollment in an IDE study on the use of the RCStim™ pulsed electromagnetic field (PEMF) device as an adjunct to surgical repair of full thickness rotator cuff tears.
The study will evaluate PEMF's ability to reduce the rate of retear, and will assess any correlation between patients treated with PEMF and improvement in muscle strength/range of motion and a decrease in pain.
The prospective, randomized, double-blind, placebo-controlled trial will enroll ~538 adult patients at up to 30 U.S. sites, with 2-year follow-up.
PEMF has long been applied to promote bone growth and assist in fracture healing. This is the company's second trial studying PEMF in soft tissue repair—the first is an assessment to treat knee osteoarthritis.
Sources: Orthofix International N.V.; ORTHOWORLD Inc.