PDF(Pubmed)
Abstract：
METHODS: A prospective multicenter clinical trial (NCT03177473) was conducted with a retrospective cohort used as a control arm.
OBJECTIVE: The purpose of this study was to evaluate cervical spine fusion rates in subjects with risk factors for pseudarthrosis who received pulsed electromagnetic field (PEMF) treatment.
BACKGROUND: Certain risk factors predispose patients to pseudarthrosis, which is associated with prolonged pain, reduced function, and decreased quality of life.
METHODS: Subjects in the PEMF group were treated with PEMF for 6 months postoperatively. The primary outcome measure was fusion status at the 12-month follow-up period. Fusion status was determined using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast).
RESULTS: A total of 213 patients were evaluated (PEMF, n=160; Control, n=53). At baseline, the PEMF group had a higher percentage of subjects who used nicotine ( P =0.01), had osteoporosis ( P <0.05), multi-level disease ( P <0.0001), and were >65 years of age ( P =0.01). The PEMF group showed over two-fold higher percentage of subjects that had ≥3 risk factors (n=92/160, 57.5%) compared with the control group (n=14/53, 26.4%). At the 12-month follow-up, the PEMF group demonstrated significantly higher fusion rates compared with the control (90.0% vs. 60.4%, P <0.05). A statistically significant improvement in fusion rate was observed in PEMF subjects with multi-level surgery ( P <0.0001) and high BMI (>30 kg/m 2 ; P =0.0021) when compared with the control group. No significant safety concerns were observed.
CONCLUSIONS: Adjunctive use of PEMF stimulation provides significant improvements in cervical spine fusion rates in subjects having risk factors for pseudarthrosis. When compared with control subjects that did not use PEMF stimulation, treated subjects showed improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries.
OBJECTIVE: The purpose of this study was to evaluate cervical spine fusion rates in subjects with risk factors for pseudarthrosis who received pulsed electromagnetic field (PEMF) treatment.
BACKGROUND: Certain risk factors predispose patients to pseudarthrosis, which is associated with prolonged pain, reduced function, and decreased quality of life.
METHODS: Subjects in the PEMF group were treated with PEMF for 6 months postoperatively. The primary outcome measure was fusion status at the 12-month follow-up period. Fusion status was determined using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast).
RESULTS: A total of 213 patients were evaluated (PEMF, n=160; Control, n=53). At baseline, the PEMF group had a higher percentage of subjects who used nicotine ( P =0.01), had osteoporosis ( P <0.05), multi-level disease ( P <0.0001), and were >65 years of age ( P =0.01). The PEMF group showed over two-fold higher percentage of subjects that had ≥3 risk factors (n=92/160, 57.5%) compared with the control group (n=14/53, 26.4%). At the 12-month follow-up, the PEMF group demonstrated significantly higher fusion rates compared with the control (90.0% vs. 60.4%, P <0.05). A statistically significant improvement in fusion rate was observed in PEMF subjects with multi-level surgery ( P <0.0001) and high BMI (>30 kg/m 2 ; P =0.0021) when compared with the control group. No significant safety concerns were observed.
CONCLUSIONS: Adjunctive use of PEMF stimulation provides significant improvements in cervical spine fusion rates in subjects having risk factors for pseudarthrosis. When compared with control subjects that did not use PEMF stimulation, treated subjects showed improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries.
摘要：
方法：进行了一项前瞻性多中心临床试验（NCT03177473），以回顾性队列作为对照。
目的：本研究的目的是评估接受脉冲电磁场（PEMF）治疗的有假关节危险因素的受试者的颈椎融合率。
背景：某些危险因素使患者易患假关节，这与长期疼痛有关，简化函数，生活质量下降。
方法：PEMF组患者术后6个月接受PEMF治疗。主要结果指标是12个月随访时的融合状态。使用前/后确定融合状态，横向,和屈曲/伸展X光片和计算机断层扫描（无造影）。
结果：总共评估了213例患者（PEMF，n=160；控制，n=53）。在基线,PEMF组使用尼古丁的受试者百分比更高(P=0.01)，有骨质疏松(P<0.05),多层次疾病（P<0.0001），年龄>65岁(P=0.01)。与对照组（n=14/53，26.4％）相比，PEMF组具有≥3个危险因素的受试者百分比（n=92/160，57.5％）高出两倍以上。在12个月的随访中，与对照组相比，PEMF组显示出明显更高的融合率(90.0%vs.60.4%,P<0.05)。与对照组相比，在进行多级手术（P<0.0001）和高BMI（>30kg/m2；P=0.0021）的PEMF受试者中观察到融合率的统计学显着改善。没有观察到重大的安全问题。
结论：在具有假关节危险因素的受试者中，辅助使用PEMF刺激可显著改善颈椎融合率。与未使用PEMF刺激的对照组相比，尽管年龄较大，接受治疗的受试者仍显示出改善的融合结果，有更多的假关节危险因素，接受更复杂的手术.
目的：本研究的目的是评估接受脉冲电磁场（PEMF）治疗的有假关节危险因素的受试者的颈椎融合率。
背景：某些危险因素使患者易患假关节，这与长期疼痛有关，简化函数，生活质量下降。
方法：PEMF组患者术后6个月接受PEMF治疗。主要结果指标是12个月随访时的融合状态。使用前/后确定融合状态，横向,和屈曲/伸展X光片和计算机断层扫描（无造影）。
结果：总共评估了213例患者（PEMF，n=160；控制，n=53）。在基线,PEMF组使用尼古丁的受试者百分比更高(P=0.01)，有骨质疏松(P<0.05),多层次疾病（P<0.0001），年龄>65岁(P=0.01)。与对照组（n=14/53，26.4％）相比，PEMF组具有≥3个危险因素的受试者百分比（n=92/160，57.5％）高出两倍以上。在12个月的随访中，与对照组相比，PEMF组显示出明显更高的融合率(90.0%vs.60.4%,P<0.05)。与对照组相比，在进行多级手术（P<0.0001）和高BMI（>30kg/m2；P=0.0021）的PEMF受试者中观察到融合率的统计学显着改善。没有观察到重大的安全问题。
结论：在具有假关节危险因素的受试者中，辅助使用PEMF刺激可显著改善颈椎融合率。与未使用PEMF刺激的对照组相比，尽管年龄较大，接受治疗的受试者仍显示出改善的融合结果，有更多的假关节危险因素，接受更复杂的手术.
