Orthofix initiates first US clinical study of osteogenesis stimulation for odontoid fractures


Orthofix has announced the first large-scale clinical study to evaluate the use of pulsed electromagnetic fields (PEMF) technology to investigate whether the therapy can improve osteogenesis 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 immobilisation with a rigid collar.

“Despite immobilisation 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,” says Richard Guyer, orthopaedic spine surgeon and president of Texas Back Institute, in Dallas, USA, and an investigator in the study.

A prospective, double-blind, randomised, placebo-controlled, multicentre 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 enrol approximately 360 patients who are 50 years of age or older at up to 50 sites in the USA. Study participants will be randomised in a 2:1 ratio to either an active or placebo control device and followed for 12 months after initiation of treatment.

“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, 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.”