Orthofix International N.V., (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced the publication of new data in Bone & Joint Research from a study evaluating the effect of pulsed electromagnetic field treatment (PEMF) for patients who have an increased risk for pseudoarthrosis (failure for the vertebrae to fuse) after anterior cervical discectomy and fusion procedures.
Study findings showed that after ACDF surgery, use of PEMF stimulation significantly increased the fusion rate relative to the control group at six and 12 months for participants who were at risk for pseudoarthrosis.1 Participants included patients who had a risk factor that could impair their cervical spine fusion success; or they had a risk factor and received at least a two- or three-level arthrodesis.
Dr. Richard D. Guyer, orthopedic spine surgeon and Chairman of the Texas Back Institute Research Foundation in Dallas and senior author of the paper said, “Anterior cervical discectomy and fusion procedures are common spinal operations in the U.S. However, successful spine fusion can be impaired in some patients, leaving them at risk for pseudoarthrosis which ultimately impacts their long-term recovery.” He concluded, “This is the first published report to show that PEMF treatment significantly increased fusion rates at both six and 12 months in high-risk patients who underwent ACDF surgery.”
The evaluations were conducted with historical data from Orthofix’s prospective, randomized, multicenter U.S. Food and Drug Administration (FDA) investigational device exemption PMA study of 323 patients conducted in 2014 and a new multicenter, retrospective cohort study consisting of 274 patients enrolled at three institutions. In the new study, participants were required to have one or more risk factors for pseudoarthrosis. All patients were treated with PEMF following ACDF surgery. The primary endpoint was fusion at six and 12 months as determined by the presence of continuous bridging bone on plain films as assessed by the treating surgeon.
“This data is important as it builds on the findings of the original Orthofix PMA study that proved the safety and effectiveness of PEMF stimulation with the Cervical-Stim device,” said James Ryaby, Ph.D., Chief Scientific Officer for Orthofix. “The results published in Bone & Joint Research support the use of PEMF treatment for high-risk ACDF patients and should help surgeons feel confident when prescribing this therapy.”
The Orthofix Cervical-Stim device is currently approved by the FDA as an adjunct to cervical spinal fusions. The device is the only bone growth therapy device approved by the FDA as a noninvasive, adjunctive treatment option for cervical fusion in high risk patients.
1.Coric D, Bullard DE, Patel VV, et al. Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations. Bone Joint Res 2018;7:124–130.