Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis

Marc A. Weinstein; Andrew Beaumont; Peter Campbell; Hamid Hassanzadeh; Vikas Patel; Amir Vokshoor; Joshua Wind; Kristen Radcliff; Ilyas Aleem; Domagoj Coric

doi:10.14444/8549

Abstract

Background Lumbar spinal fusion surgeries are increasing steadily due to an aging and ever-growing population. Patients undergoing lumbar spinal fusion surgery may present with risk factors that contribute to complications, pseudarthrosis, prolonged pain, and reduced quality of life. Pulsed electromagnetic field (PEMF) stimulation represents an adjunct noninvasive treatment intervention that has been shown to improve successful fusion and patient outcomes following spinal surgery.

Methods A prospective, multicenter study investigated PEMF as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis. Patients with at least 1 of the following risk factors were enrolled: prior failed fusion, multilevel fusion, nicotine use, osteoporosis, or diabetes. Fusion status was determined by radiographic imaging, and patient-reported outcomes were also evaluated.

Results A total of 142 patients were included in the analysis. Fusion status was assessed at 12 months follow-up where 88.0% (n = 125/142) of patients demonstrated successful fusion. Fusion success for patients with 1, 2+, or 3+ risk factors was 88.5%, 87.5%, and 82.3%, respectively. Significant improvements in patient-reported outcomes using the Short Form 36, EuroQol 5 Dimension (EQ-5D) survey, Oswestry Disability Index, and visual analog scale for back and leg pain were also observed compared with baseline scores (P < 0.001). A favorable safety profile was observed. PEMF treatment showed a positive benefit-risk profile throughout the 6-month required use period.

Conclusions The addition of PEMF as an adjunct treatment in patients undergoing lumbar spinal surgery provided a high rate of successful fusion with significant improvements in pain, function, and quality of life, despite having risk factors for pseudarthrosis.

Clinical Relevance PEMF represents a useful tool for adjunct treatment in patients who have undergone lumbar spinal surgery. Treatment with PEMF may result in improved fusion and patient-reported outcomes, regardless of risk factors.

Trial Registration NCT03176303

Footnotes

Funding This study was supported by Orthofix US LLC (Lewisville, TX, USA).
Declaration of Conflicting 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 G. 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. Vikas Patel reports grants/contracts from Mainstay Medical, Medicrea, Medtronic, Orthofix, Pfizer, and Spinal Kinetics; consulting fees from Spine Welding and SI Bone; and payment/honoraria from Mainstay Medical. Kristen Radcliff reports consulting fees from Orthofix, 4 web, and Stryker and stock/stock options from 4web and Orthoson. Amer Vokshoor reports research contracts from Spine Art, Orthofix, and Synergy and royalties/licenses from Globus Medical. Joshua J. 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.
Author Contributions All authors have contributed to at least (1) study concept/design, (2) data acquisition, (3) statistical analysis and/or data interpretation. All authors have read and agreed to the published version of the manuscript.
Institutional Review Board Statement The study was conducted in accordance with the Declaration of Helsinki and approved by the Central Western Institutional Review Board (IRB) and local IRBs where applicable (at the Aspirus Research Institute, University of Virginia, and Rothman Institute).
Data Availability Statement Data supporting the findings of this study are available upon reasonable request.
Patient Consent Informed consent was obtained from all patients involved in the study.

This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2023 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.

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