Department of Diagnostic and Molecular Imaging, Interventional Radiology, Nuclear Medicine and Radiation Therapy, University of Rome Tor Vergata, viale Oxford 81, 00133, Rome, Italy.
Cardiovasc Intervent Radiol. 2012 Apr;35(2):368-74. doi: 10.1007/s00270-011-0167-1. Epub 2011 May 28.
This study was designed to evaluate the feasibility of the implantation of a new interspinous device (Falena) in patients with lumbar spinal stenosis. The clinical outcomes and imaging results were assessed by orthostatic MR during an up to 6-month follow-up period.
Between October 2008 and February 2010, the Falena was implanted at a single level in 26 patients (17 men; mean age, 69 (range, 54-82) years) who were affected by degenerative lumbar spinal stenosis. All of the patients were clinically evaluated before the procedure and at 1 and 3 months. Furthermore, 20 patients have completed a 6-month follow-up. Pain was assessed before and after the intervention using the Visual Analogue Scale score and the Oswestry Disability Index questionnaire. Orthostatic MR imaging was performed before the implantation and at 3 months to assess the correlation with the clinical outcome.
The mean ODI score decreased from 48.9 before the device implantation to 31.2 at 1 month (p < 0.0001). The mean VAS score decreased from 7.6 before to 3.9 (p < 0.0001) at 1 month and 3.6 at 3 months after the procedure (p = 0.0115). These values were stable at 6 months evaluation. No postimplantation major complications were recorded. MRI evaluation documented in most cases an increased size of the spinal canal area. Similarly a bilateral foraminal area improvement was found. The variation of the intervertebral space height measured on the posterior wall was not significant.
In our preliminary experience with the Falena in a small cohort of patients, we obtained clinical and imaging results aligned to those reported with similar interspinous devices.
本研究旨在评估在腰椎管狭窄症患者中植入新型棘突间装置（Falena）的可行性。通过长达 6 个月的随访期间的直立 MRI 评估临床结果和影像学结果。
2008 年 10 月至 2010 年 2 月期间，26 名患者（17 名男性；平均年龄 69 岁[范围 54-82 岁]）接受了 Falena 单节段植入手术。所有患者在术前和术后 1 个月和 3 个月进行了临床评估。此外，20 名患者完成了 6 个月的随访。在干预前后使用视觉模拟量表评分和 Oswestry 残疾指数问卷评估疼痛。在植入前和 3 个月进行直立 MRI 成像，以评估与临床结果的相关性。
ODI 评分从植入前的 48.9 平均分降至 1 个月时的 31.2（p<0.0001）。VAS 评分从植入前的 7.6 平均分降至 1 个月时的 3.9（p<0.0001）和 3 个月时的 3.6（p=0.0115）。这些值在 6 个月评估时保持稳定。未记录到植入后的重大并发症。MRI 评估在大多数情况下记录了椎管面积的增加。同样，双侧椎间孔面积也得到了改善。在后壁上测量的椎间空间高度的变化不显著。
在我们对一小批患者使用 Falena 的初步经验中，我们获得了与类似棘突间装置报告的临床和影像学结果一致的结果。
