Pulsed Electromagnetic Fields for Cervical Spine Fusion in Patients with Risk Factors for Pseudarthrosis.

Background: Certain demographics and/or risk factors contribute to complications following cervical spinal surgery including pseudarthrosis, prolonged pain, and reduced quality of life (QoL). Pulsed electromagnetic field (PEMF) stimulation is a non-invasive therapy that may enhance fusion success in at-risk patients.
Objective: To evaluate the safety and efficacy of post-operative adjunctive PEMF therapy following cervical spinal surgery in subjects at risk for pseudarthrosis.
Methods: This prospective, multicenter study investigated PEMF as an adjunctive therapy to cervical spinal fusion procedures in subjects at risk for pseudarthrosis based on having at least one of the following: prior failed fusion, multi-level fusion, nicotine use, osteoporosis, or diabetes. Radiographic fusion status and patient-reported outcomes (SF-36, EQ5D, NDI, and VAS-arm pain and VAS-neck pain) were assessed.
Results: A total of 160 subjects were assessed for fusion 12-months postoperative, and 144 subjects were successfully fused (90.0%). Fusion success for subjects with 1, 2+, or 3+ risk factors was 91.7%, 89.0%%, and 90.9%, respectively. Significant improvements in NDI, VAS-arm and VAS-neck were observed compared to baseline scores (p < 0.001) along with improvements in SF-36 and EQ5D (p < 0.001).
Conclusions: Adjunctive treatment with PEMF provides a high rate of successful fusion and significant improvements in pain, function, and quality of life despite having risk factors for pseudarthrosis.
Competing Interests: All authors have received financial support from Orthofix US LLC for their involvement in the study. Orthofix US LLC was involved in the design of the study, analyses, and interpretation of data and in writing of the manuscript. In addition, Ilyas Aleem reports receiving consulting fees from Globus. Peter Campbell reports receiving payment/honoraria from Stryker (speakers’ bureau) and serves as a consultant for Nexus Spine. Dom Coric reports royalties/licenses and consulting fees from Medtronic, Globus/Nuvasive, and SpineWave and stock/ stock options from SpineWave and Premia. Kristen Radcliff reports consulting fees from Orthofix, 4 web, and Stryker and stock/stock options from 4web and Orthoson. Amir Vokshoor reports research contracts from Spine Art, Orthofix, and Synergy and royalties/licenses from Globus Medical. Joshua Wind reports payment/honoraria from Orthofix (speaker’s fee). Hamid Hassanzadeh reports consulting fees from Nuvasive, Medtronic, DePuy, and Orthofix; payment/honoraria from Pfizer and Nuvasive; support for attending meetings from Nuvasive; and a leadership role at the Scoliosis Research Society.