Masala Salvatore, Marcia Stefano, Taglieri Amedeo, Chiaravalloti Antonio, Calabria Eros, Raguso Mario, Piras Emanuele, Simonetti Giovanni
Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
UOC Unitá Operativa Complessa Radiologia, Ospedale SS, Santissima Trinitá, Cagliari, Italy.
Interv Neuroradiol. 2016 Apr;22(2):217-26. doi: 10.1177/1591019915622163. Epub 2016 Jan 14.
Evaluation of the efficacy of the Falena(®) and Aperius™ PerCLID™ interspinous devices in the treatment of degenerative lumbar spinal stenosis with neurogenic intermittent claudication refractory to conservative treatment.
We retrospectively analyzed data from 24 patients (20 male and 4 female patients; 61 ± 7 years old), treated with an implantation of the AperiusTM PerCLID™ system, and from 35 patients (29 male and 6 female patients; 65 ± 9 years old) treated with the Falena(®) interspinous device.Patient pain intensity was evaluated by a 10-point visual analog scale (VAS), with a score (ranging from 0 = no pain to 10 = unbearable pain) that was collected before the procedure, at baseline; and at months 1, 6 and 12 after the interventional procedure. The assessment of quality of life (QOL) impairment was evaluated by the Oswestry Disability Index (ODI) questionnaire, which was administered beforehand at baseline; and at months 1, 6 and 12 after the interventional procedure. The vertebral canal area was measured by magnetic resonance imaging (MRI) scans before the treatment and at the one-year follow-up.
All patients completed the study with no complications. Both the Falena group and Aperius group of surgery patients showed a statistically significant reduction of their VAS and ODI scores at the 6- and 12-month follow-up (p < 0.0001). A statistically significant increase in the vertebral canal area was observed both in the group that received Falena (p < 0.0001) and in the group that received Aperius (p = 0.0003). At the 1-year follow-up, we observed that there was a higher increase of vertebral canal area in those patients whom were treated with the Falena device (p < 0.001).
The implantation of Falena(®) and Aperius™ PerCLID™ interspinous devices is an effective and safe procedure, in the medium term.
评估Falena（®）和Aperius™ PerCLID™棘突间装置治疗经保守治疗无效的神经源性间歇性跛行的退行性腰椎管狭窄症的疗效。
我们回顾性分析了24例（20例男性和4例女性患者；61±7岁）接受AperiusTM PerCLID™系统植入治疗的患者以及35例（29例男性和6例女性患者；65±9岁）接受Falena（®）棘突间装置治疗的患者的数据。通过10分视觉模拟量表（VAS）评估患者的疼痛强度，分数范围为0 =无疼痛至10 =难以忍受的疼痛，在手术前、基线时以及介入手术后1、6和12个月收集该分数。通过Oswestry功能障碍指数（ODI）问卷评估生活质量（QOL）损害情况，该问卷在基线时预先进行，以及在介入手术后1、6和12个月进行。在治疗前和一年随访时通过磁共振成像（MRI）扫描测量椎管面积。
所有患者均完成研究且无并发症。Falena组和Aperius组手术患者在6个月和12个月随访时VAS和ODI评分均有统计学显著降低（p < 0.0001）。接受Falena治疗的组（p < 0.0001）和接受Aperius治疗的组（p = 0.0003）椎管面积均有统计学显著增加。在1年随访时，我们观察到接受Falena装置治疗的患者椎管面积增加更高（p < 0.001）。
中期来看，植入Falena（®）和Aperius™ PerCLID™棘突间装置是一种有效且安全的手术。
