Objective: 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.
Methods: 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.
Results: 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.
Conclusions: 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.