Marc A Weinstein, Andrew Beaumont, Peter Campbell, Hamid Hassanzadeh, Vikas Patel, Amir Vokshoor, Joshua Wind, Kristen Radcliff, Ilyas Aleem, Domagoj Coric
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引用次数: 0
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.
背景：由于人口老龄化和不断增长，腰椎融合术正在稳步增加。接受腰椎融合术的患者可能存在导致并发症、假关节、疼痛延长和生活质量降低的风险因素。脉冲电磁场（PEMF）刺激是一种辅助的非侵入性治疗干预措施，已被证明可以改善脊柱手术后的成功融合和患者预后。方法：一项前瞻性、多中心研究研究了PEMF作为腰椎融合术的辅助治疗假关节风险患者。至少有以下1种风险因素的患者被纳入研究：既往融合失败、多水平融合、尼古丁使用、骨质疏松或糖尿病。融合状态通过放射学成像确定，并对患者报告的结果进行评估。结果：共有142名患者被纳入分析。在12个月的随访中评估融合状态，88.0%（n=125/142）的患者证明融合成功。有1、2+或3+危险因素的患者融合成功率分别为88.5%、87.5%和82.3%。与基线评分相比，使用Short Form 36、EuroQol 5 Dimension（EQ-5D）调查、Oswestry残疾指数和背部和腿部疼痛视觉模拟量表的患者报告结果也有显著改善（P<0.001）。观察到良好的安全性。PEMF治疗在所需的6个月使用期内显示出积极的获益风险状况。结论：PEMF作为腰椎手术患者的辅助治疗，尽管有假关节的危险因素，但融合成功率高，疼痛、功能和生活质量显著改善。临床相关性：PEMF是对接受腰椎手术的患者进行辅助治疗的有用工具。PEMF治疗可以改善融合和患者报告的结果，而不考虑风险因素。试验注册号：NCT03176303。
期刊介绍：
The International Journal of Spine Surgery is the official scientific journal of ISASS, the International Intradiscal Therapy Society, the Pittsburgh Spine Summit, and the Büttner-Janz Spinefoundation, and is an official partner of the Southern Neurosurgical Society. The goal of the International Journal of Spine Surgery is to promote and disseminate online the most up-to-date scientific and clinical research into innovations in motion preservation and new spinal surgery technology, including basic science, biologics, and tissue engineering. The Journal is dedicated to educating spine surgeons worldwide by reporting on the scientific basis, indications, surgical techniques, complications, outcomes, and follow-up data for promising spinal procedures.
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