title: Percutaneous decompression of lumbar spinal stenosis with a new interspinous device.
abstract: 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.
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology, Nuclear Medicine and Radiation Therapy, University of Rome Tor Vergata, viale Oxford 81, 00133, Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Masala
authors.forename: Roberto
authors.initials: R
authors.lastname: Fiori
authors.forename: Dario Alberto
authors.initials: DA
authors.lastname: Bartolucci
authors.forename: Tommaso
authors.initials: T
authors.lastname: Volpi
authors.forename: Eros
authors.initials: E
authors.lastname: Calabria
authors.forename: Federica
authors.initials: F
authors.lastname: Novegno
authors.forename: Giovanni
authors.initials: G
authors.lastname: Simonetti
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019072:Antibiotic Prophylaxis; D015331:Cohort Studies; D019299:Decompression, Surgical / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000517:prevention & control; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D011859:Radiography; D012189:Retrospective Studies; D013130:Spinal Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000534:rehabilitation / Q000601:surgery*