Coric D, Bullard D E, Patel V V, Ryaby J T, Atkinson B L, He D, Guyer R D
Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina, USA.
Triangle Neurosurgery, 1540 Sunday Drive, Suite 214, Raleigh, North Carolina 27607, USA.
Bone Joint Res. 2018 Feb;7(2):124-130. doi: 10.1302/2046-3758.72.BJR-2017-0221.R1.
Pulsed electromagnetic field (PEMF) stimulation was evaluated after anterior cervical discectomy and fusion (ACDF) procedures in a randomized, controlled clinical study performed for United States Food and Drug Administration (FDA) approval. PEMF significantly increased fusion rates at six months, but 12-month fusion outcomes for subjects at elevated risk for pseudoarthrosis were not thoroughly reported. The objective of the current study was to evaluate the effect of PEMF treatment on subjects at increased risk for pseudoarthrosis after ACDF procedures.
Two evaluations were performed that compared fusion rates between PEMF stimulation and a historical control (160 subjects) from the FDA investigational device exemption (IDE) study: a (PH) analysis of high-risk subjects from the FDA study (PH PEMF); and a multicentre, open-label (OL) study consisting of 274 subjects treated with PEMF (OL PEMF). Fisher's exact test and multivariate logistic regression was used to compare fusion rates between PEMF-treated subjects and historical controls.
In separate comparisons of PH PEMF and OL PEMF groups to the historical control group, PEMF treatment significantly (p < 0.05, Fisher's exact test) increased the fusion rate at six and 12 months for certain high-risk subjects who had at least one clinical risk factor of being elderly, a nicotine user, osteoporotic, or diabetic; and for those with at least one clinical risk factor and who received at least a two- or three-level arthrodesis.
Adjunctive PEMF treatment can be recommended for patients who are at high risk for pseudoarthrosis.: D. Coric, D. E. Bullard, V. V. Patel, J. T. Ryaby, B. L. Atkinson, D. He, R. D. Guyer. Pulsed electromagnetic field stimulation may improve fusion rates in cervical arthrodesis in high-risk populations. 2018;7:124-130. DOI: 10.1302/2046-3758.72.BJR-2017-0221.R1.
在美国食品药品监督管理局（FDA）批准的一项随机对照临床研究中，对颈椎前路椎间盘切除融合术（ACDF）后进行脉冲电磁场（PEMF）刺激进行了评估。PEMF在6个月时显著提高了融合率，但对于假关节形成风险较高的受试者，12个月时的融合结果并未得到充分报道。本研究的目的是评估PEMF治疗对ACDF术后假关节形成风险增加的受试者的影响。
进行了两项评估，比较了PEMF刺激与FDA研究性器械豁免（IDE）研究中的历史对照（160名受试者）之间的融合率：对FDA研究中的高风险受试者进行的倾向评分（PH）分析（PH PEMF）；以及一项由274名接受PEMF治疗的受试者组成的多中心开放标签（OL）研究（OL PEMF）。采用Fisher精确检验和多变量逻辑回归来比较接受PEMF治疗的受试者与历史对照之间的融合率。
在将PH PEMF组和OL PEMF组分别与历史对照组进行比较时，对于某些具有至少一项临床风险因素（年龄较大、吸烟、骨质疏松或糖尿病）的高风险受试者，以及那些具有至少一项临床风险因素且接受至少两级或三级关节融合术的受试者，PEMF治疗在6个月和12个月时显著（p < 0.05，Fisher精确检验）提高了融合率。
对于假关节形成风险较高的患者，可推荐辅助性PEMF治疗。D. 科里克、D. E. 布拉德、V. V. 帕特尔、J. T. 里亚比、B. L. 阿特金森、D. 何、R. D. 盖耶。脉冲电磁场刺激可能会提高高风险人群颈椎融合术中的融合率。2018；7：124 - 130。DOI：10.1302/2046 - 3758.72.BJR - 2017 - 0221.R1。
