Orthofix (NSDQ:OFIX) said it initiated a large-scale U.S. clinical trial to evaluate the effectiveness of its Cervical-Stim bone-stimulating device in the treatment of fractures involving the odontoid process of the spine.
The randomized study will track approximately 360 patients of age 50 and up to see whether Cervical-Stim is able to help heal odontoid fractures. The product, which uses pulsed electromagnetic fields to stimulate bone fusion, is already approved in the U.S. for improving cervical fusion outcomes.
Odontoid fractures, which involve the 2nd cervical vertebra, are most often caused by motor vehicle accidents or, in the case of the elderly, falling from a standing position. If the bone fails to heal properly, the base of the skull may become unstable, which could result in neurological problems or even death, according to Orthofix.
Nearly 22,000 odontoid fractures are reported in the U.S. annually. Currently, there are no treatments approved to help speed recovery or improve outcomes, Orthofix said.
"Initiation of the odontoid fracture study represents an important step in obtaining clinical evidence to support new indications and reimbursement for our PEMF technology," chief scientific officer James Ryaby said in a statement. "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."