Clinical trial will evaluate the Company's proprietary PEMF technology for reducing tendon retears
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.
"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," said Dr.
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
"PEMF technology has been used for many years to promote bone growth and
the healing of nonunion fractures," said
The Orthofix RCStim device is an investigational device and use in the
study is being conducted under an Investigational Device Exemption (IDE)
Orthofix PEMF technology devices are currently approved by the
About Rotator Cuff Tears
According to the
Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company's mission is to improve patients' lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company's sales representatives and distributors. For more information, please visit www.orthofix.com.
This communication contains certain forward-looking statements under the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements, which may include, but are not limited to, statements
concerning the projections, financial condition, results of operations
and businesses of
News Provided by Acquire Media