Orthofix Initiates First US Clinical Study Of Osteogenesis Stimulation For Odontoid Fractures

Orthofix International N.V., OFIX, today announced the Company's first large-scale clinical study to evaluate the use of pulsed electromagnetic fields (PEMF) technology to see if the therapy can improve osteogenesis (bone growth) in Type II odontoid fractures. The study will examine the safety and effectiveness of PEMF treatment with the Orthofix Cervical-Stim® device as an adjunct to standard immobilization with a rigid collar. “Typically we see Type II odontoid fractures in patients as the result of a bad fall or a car accident,” said Dr. Richard Guyer, orthopedic spine surgeon and President of Texas Back Institute in Dallas, TX and an investigator in the study. “Despite immobilization or in some cases surgical fixation, often the bones do not heal correctly. Cervical PEMF stimulation may provide us with an additional treatment approach that can enhance odontoid fracture healing.” A prospective, double-blind, randomized, placebo-controlled, multicenter clinical trial, the Odontoid Fracture Study will investigate the safety and effectiveness of PEMF therapy with the Orthofix Cervical-Stim device in patients with Type II fractures of the odontoid process. The study will enroll approximately 360 patients who are 50 years of age or older at up to 50 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 12 months after initiation of treatment. The odontoid study is a direct result of Orthofix's previously announced strategy for conducting clinical trials to expand the Company's PEMF indications. “Initiation of the Odontoid Fracture Study represents an important step in obtaining clinical evidence to support new indications and reimbursement for our PEMF technology,” said James Ryaby, Ph.D., Chief Scientific Officer for Orthofix. “We are hopeful that the results of this study will support the use of Cervical-Stim as an adjunct therapy for managing patients with these difficult to treat injuries.” The Orthofix Cervical-Stim device is currently approved by the U.S. Food and Drug Administration (FDA) as a noninvasive, adjunctive treatment option for improving cervical fusion outcomes. The device uses a low-level electromagnetic field (PEMF) that helps activate and augment the body's natural healing process to enhance vertebral bone fusion. In the study, the Cervical-Stim device will be worn directly over a rigid collar. Use in the Odontoid Fracture Study is investigational and is being conducted under an Investigational Device Exemption (IDE) from the FDA. More information is available at ClinicalTrials.gov.