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

Abstract

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.