Phillips Mark, Zoltan Jon, Petrisor Brad A, Sprague Sheila, Baumhauer Judy
Global Research Solutions, Inc., Burlington, Ontario, Canada.
The Orthopedic Clinic Association, Phoenix, Arizona.
J Long Term Eff Med Implants. 2016;26(3):261-270. doi: 10.1615/JLongTermEffMedImplants.2016016816.
This study evaluated the effectiveness and safety of bone growth stimulation using combined magnetic field (CMF) for the treatment of fracture nonunions. In this prospective multicenter study, patients were assessed monthly for 9 mo, or until they demonstrated a healed nonunion, and were assessed at a final follow-up 3 mo after treatment completion. The primary outcome was the presence or absence of fracture healing at the nonunion site, determined by clinical and radiographic assessment. Enrolled in this study were 112 patients with 116 fracture nonunions. Fifty-two (44.8%) patients demonstrated a healed nonunion between treatment initiation and 12-mo- posttreatment initiation (9 mo of treatment plus 3 mo posttreatment follow-up). Tibial nonunions had a higher percentage of healed fractures compared to other fracture types (78% vs. 46.5%, respectively; p = 0.004). This study demonstrated that noninvasive CMF technology healed 78% of tibial fracture nonunions and 45% of all fracture nonunions (p = 0.004). Additionally, pain at rest, with stress, and on weight bearing all decreased following treatment with CMF, with no adverse events reported. These results indicate that CMF is a beneficial noninvasive treatment modality for nonunions.
本研究评估了联合磁场(CMF)刺激骨生长治疗骨折不愈合的有效性和安全性。在这项前瞻性多中心研究中,对患者进行为期9个月的每月评估,或直至其骨折不愈合处显示愈合,在治疗完成后3个月进行最终随访评估。主要结局是通过临床和影像学评估确定骨折不愈合部位是否存在骨折愈合。本研究纳入了112例患者的116处骨折不愈合。52例(44.8%)患者在治疗开始至治疗开始后12个月(9个月治疗加3个月治疗后随访)期间显示骨折不愈合处愈合。与其他骨折类型相比,胫骨骨折不愈合的愈合骨折百分比更高(分别为78%和46.5%;p = 0.004)。本研究表明,非侵入性CMF技术使78%的胫骨骨折不愈合和45%的所有骨折不愈合得以愈合(p = 0.004)。此外,CMF治疗后静息时、应力下和负重时的疼痛均减轻,且未报告不良事件。这些结果表明,CMF是一种治疗骨折不愈合的有益非侵入性治疗方式。
J Long Term Eff Med Implants. 2016
J Long Term Eff Med Implants. 2016
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