Effect of Pulsed Electromagnetic Field on the Consolidation of Posterolateral Arthrodeses in the Lumbosacral Spine: A Prospective, Double-Blind, Randomized Study

Abstract

Objective: To assess the effect of pulsed electromagnetic field (PEMF) on the consolidation of instrumented lumbar posterolateral arthrodeses in patients who have been surgically treated for degenerative spine disease. Methods: Forty cases were recruited from 163 consecutive patients undergoing lumbar arthrodesis at the same center. The patients were randomized into two groups of 20 patients: Active Group, who were exposed to PEMF for 4 hours a day for 90 days after surgery, and Inactive Group, who received an identical device, with the same instructions for use but without the ability to generate PEMF. The patients underwent computed tomography scans at 45, 90, 180 and 360 days after surgery to check for the occurrence of arthrodesis at each operated spinal level. Results: In the course of the study, two patients were excluded from each group. There were no significant differences between the groups with respect to age, gender, smoking habit, or the number of vertebral levels included in the arthrodesis. The percentage of consolidation of the vertebral levels increased at 90, 180 and 360 days compared to 45 days (p<0.001) in both groups. The Active Group had a 276% greater chance of consolidation in the vertebral levels (OR = 3.76; 95% CI: 1.39-10.20), regardless of the time of evaluation. Patients in the Active Group presented 16% more consolidation than patients in the inactive group (p=0.018). Conclusions: Post-operative exposure to PEMF following instrumented arthrodesis of the lumbar spine for degenerative spine disease increased consolidation in the first year after surgery.Keywords: Randomized controlled trials as topic; Spinal fusion; Spine; Electromagnetic fields; Arthrodesis. (OR = 3,76; IC 95%: 1,20) RESUMO Objetivo: Avaliar o efeito do campo eletromagnético pulsado (CEMP) na consolidação de artrodeses posterolaterais lombares instrumentadas em pacientes que foram tratados cirurgicamente de doença degenerativa da coluna vertebral. Métodos: Quarenta casos foram recrutados de 163 pacientes consecutivos submetidos à artrodese lombar no mesmo centro. Os pacientes foram randomizados em dois grupos de 20 pacientes: Grupo Ativo, que foi exposto a CEMP por 4 horas por dia durante 90 dias após a cirurgia e Grupo Inativo, que recebeu um dispositivo idêntico, com as mesmas instruções de uso, mas sem a capacidade de gerar CEMP. Os pacientes foram submetidos a exames de tomografia computadorizada aos 45, 90, 180 e 360 dias após a cirurgia para verificar a ocorrência de artrodese em cada nível espinhal operado. Resultados: No decorrer do estudo, dois pacientes foram excluídos de cada grupo. Não houve diferenças significativas entre os grupos com relação à idade, sexo, tabagismo ou número de níveis vertebrais incluídos na artrodese. A percentagem de consolidação dos níveis vertebrais aumentou aos 90, 180 e 360 dias em comparação com 45 dias (p < 0,001) em ambos os grupos. O Grupo Ativo teve uma chance de consolidação 276% maior nos níveis vertebrais

Harnessing electromagnetic fields to assist bone tissue engineering

“…A randomized double-blind prospective study demonstrated that 92.2% of patients in PEMF treatment group had a successful fusion as determined by blinded radiographic evaluation, while the control group had a success rate of 67.9% [ 190 ]. Other clinical trials also advocated the application of PEMF for spinal fusion [ 191 , 192 ]. Conclusively, PEMF proves its benefits in clinically treating bone defects.…”