Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion

Foley, Kevin T.; Mroz, Thomas E.; Arnold, Paul M.; Chandler, Howard C.; Dixon, Robert; Girasole, Gerard J.; Renkens, Kenneth L.; Riew, K. Daniel; Sasso, Rick C.; Smith, Richard C.; Tung, Howard; Wecht, Daniel A.; Whiting, Donald

doi:10.1016/j.spinee.2007.06.006

Cited by 68 publications

(72 citation statements)

References 21 publications

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“…The benefit of the applied mechanical signal continued even during the 4-week rest period, perhaps suggesting the additional bone and vessels formed during the treatment period acted as a secondary resource for osteogenic and stem cells or the mechanism triggered by the signal remained active even after the stimulus had subsided [42]. The robust osteogenic effects of this noninvasive treatment observed after the 8-week experimental period also emphasizes some advantages over tissue-engineering approaches that rely on stem cells and/or physical signals such as ultrasound, electrical currents, or electromagnetic fields [1,11,28,43]. Not only is application of the physical signal noninvasive, simple, and inexpensive, it also does not require incubation time, bears no substantial risk of transmitting infections and diseases, and is unlikely to promote development of tumors from electrical waves.…”

Section: Discussionmentioning

confidence: 92%

“…Tissue-engineering approaches, including stem cells and growth factors [18,24] or externally applied signals such as stimulation with electric currents [7,11], ultrasound [10,43], or laser [28], are promising in overcoming these problems, but they also have several shortcomings. Current cell culture-based techniques require considerable resources to reach the number of required cells, bear risks for transfer of infectious diseases, and involve invasive surgery [40].…”

Section: Introductionmentioning

confidence: 99%

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Extremely Small-magnitude Accelerations Enhance Bone Regeneration: A Preliminary Study

Hwang

Lublinsky

Seo

et al. 2008

Clin Orthop Relat Res

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High-frequency, low-magnitude accelerations can be anabolic and anticatabolic to bone. We tested the hypothesis that application of these mechanical signals can accelerate bone regeneration in scaffolded and nonscaffolded calvarial defects. The cranium of experimental rats (n = 8) in which the 5-mm bilateral defects either contained a collagen scaffold or were left empty received oscillatory accelerations (45 Hz, 0.4 g) for 20 minutes per day for 3 weeks. Compared with scaffolded defects in the untreated control group (n = 6), defects with a scaffold and subject to oscillatory accelerations had a 265% greater fractional bone defect area 4 weeks after the surgery. After 8 weeks of healing (1-week recovery, 3 weeks of stimulation, 4 weeks without stimulation), the area (181%), volume (137%), and thickness (53%) of the regenerating tissue in the scaffolded defect were greater in experimental than in control animals. In unscaffolded defects, mechanical stimulation induced an 84% greater bone volume and a 33% greater thickness in the defect. These data provide preliminary evidence that extremely low-level, high-frequency accelerations can enhance osseous regenerative processes, particularly in the presence of a supporting scaffold.

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Section: Discussionmentioning

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Extremely Small-magnitude Accelerations Enhance Bone Regeneration: A Preliminary Study

Hwang

Lublinsky

Seo

et al. 2008

Clin Orthop Relat Res

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“…Since it was recently demonstrated that PEMFs are able to speed up cervical spine fusion after surgery [10], we also aimed to investigate the effect of PEMFs on human osteoclasts cultures, to better understand if different types of electromagnetic fields could differently affect the same cell culture, and also to find potential therapeutic strategies.…”

Section: Discussionmentioning

confidence: 99%

“…Pulsed electromagnetic fields (PEMFs) have shown to accelerate spine fusion in patients managed with anterior cervical discectomy and fusion [10].…”

Section: Introductionmentioning

confidence: 99%

Clinical significance of different effects of static and pulsed electromagnetic fields on human osteoclast cultures

et al. 2011

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Electromagnetic fields are known to affect the bone metabolism by modifying some relevant physiologic cell parameters of cells, even though the underlying mechanisms are still unclear. The aim of our study was to evaluate the effect of both static magnetic fields (SMFs) of the same intensity of the one generated by spinal metal devices and pulsed electromagnetic fields (PEMFs) of the same intensity used for the management of nonunion on human osteoclasts cell culture. Primary osteoclast cells were isolated from primary human osteoclast precursors and were exposed to SMFs and to PEMFs. Morphology and tartrate-resistant acid phosphatase (TRAP) activity were evaluated in the osteoclast cultures after 7, 10, and 14 days of exposure. The SMF-exposed cells show a more differentiated phenotype and a significantly higher TRAP activity after 7 and 10 days of treatment with respect to a sham control. PEMF-exposed cells have a less-differentiated phenotype after 7 days of exposure compared with the relative sham control, while the TRAP activity shows no statistically significant differences between exposed and control cells at any observation time. Our results indicate that SMFs of the same intensity of the one generated around spinal devices can affect osteoclast differentiation and activity. Aseptic loosening around titanium implants might be due in part to an increased osteoclast activity and differentiation. PEMFs of the same intensity than the one used for the management of nonunions can affect osteoclasts phenotype after 7 days of exposure, while osteoclasts TRAP activity is not affected by this kind of electromagnetic fields.

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“…An acceleration of consolidation was observed with PEMF, with an increased consolidation rate at 6 months after surgery, but no statistically significant results were observed at 12 months. 53 Our study aimed to evaluate the most widespread type of arthrodesis in our setting and the use of local autograft, which is a method with lower morbidity and surgical cost. We found that consolidation in the group using the PEMF generating device occurred earlier than in the control group, although there was a trend over the follow-up period for the consolidation rates to become closer to those of the control group.…”

Section: Effect Of Pulsed Electromagnetic Field On the Consolidation mentioning

confidence: 99%

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

et al. 2017

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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

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Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion

Cited by 68 publications

References 21 publications

Extremely Small-magnitude Accelerations Enhance Bone Regeneration: A Preliminary Study

Extremely Small-magnitude Accelerations Enhance Bone Regeneration: A Preliminary Study

Clinical significance of different effects of static and pulsed electromagnetic fields on human osteoclast cultures

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

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