title: Degenerative lumbar spinal stenosis treatment with Aperius™ PerCLID™ system and Falena® interspinous spacers: 1-year follow-up of clinical outcome and quality of life.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  The implantation of Falena(®) and Aperius™ PerCLID™ interspinous devices is an effective and safe procedure, in the medium term.
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Masala
authors.affiliation: UOC Unitá Operativa Complessa Radiologia, Ospedale SS, Santissima Trinitá, Cagliari, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Marcia
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
authors.forename: Amedeo
authors.initials: A
authors.lastname: Taglieri
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Chiaravalloti
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
authors.forename: Eros
authors.initials: E
authors.lastname: Calabria
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy marioraguso@hotmail.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Raguso
authors.affiliation: UOC Unitá Operativa Complessa Radiologia, Ospedale SS, Santissima Trinitá, Cagliari, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Piras
authors.affiliation: Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Simonetti
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology; D016268:Internal Fixators / Q000009:adverse effects; D055959:Intervertebral Disc Degeneration / Q000523:psychology / Q000601:surgery*; D008161:Lumbosacral Region / Q000601:surgery*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D010147:Pain Measurement; D019919:Prosthesis Implantation / Q000379:methods; D011788:Quality of Life; D012189:Retrospective Studies; D013130:Spinal Stenosis / Q000523:psychology / Q000601:surgery*; D016896:Treatment Outcome
keywords: Degenerative disease; interspinous devices; interspinous spacers; lumbar spinal stenosis; medical devices; neurogenic intermittent claudication; percutaneous interspinous device; spinal surgery; vertebral canal