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Orthofix International N.V., a global medical device company focused on musculoskeletal healing products and value-added services, today announced that enrollment has begun in a study that will evaluate the use of pulsed electromagnetic field (PEMF) 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.
“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. Andrew Kuntz, an orthopedic shoulder surgeon at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia and an investigator in the clinical study. “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.”
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 (inactive) device and followed for 24 months after initiation of treatment.
“PEMF technology has been used for many years to promote bone growth and the healing of nonunion fractures,” said James Ryaby, Ph.D., Chief Scientific Officer for Orthofix. “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.”
About Rotator Cuff Tears
According to the American Academy of Orthopaedic Surgeons, rotator cuff tears send as many as two million Americans to their physicians’ offices every year, many with a full-thickness or complete tear. A full-thickness tear means the tendon has separated from the bone. This common musculoskeletal injury often requires surgical intervention. An estimated 250,000 patients get rotator cuff surgery in the U.S. annually.
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 Further Information
More on the orthopedic soft tissue repair market in the U.S. can be found in a series of reports published by iData Research entitled the U.S Market Report Suite for Orthopedic Soft Tissue Repair and Sports Medicine. The suite covers reports on the following markets: tendon reinforcement grafts, suture anchors, tenodesis screws, ACL/PCL replacement allografts, interference screws, intratunnel fixation devices, cortical fixation devices, cross-pins, washer and post, osteochondral allografts, meniscal allografts, autologous chondrocyte implantation, particulated juvenile allograft implant, microfracture adjunct, suture meniscal repair devices, implant meniscal repair devices, hybrid meniscal repair devices, hip radiofrequency probes, banana blades, hip access kits and disposable suture passers.
The iData report series on orthopedic soft tissue repair covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about orthopedic soft tissue repair market data, register online or email us at [email protected] for a U.S Market Report Suite for Orthopedic Soft Tissue Repair and Sports Medicine brochure and synopsis.