Salvatore Masala1, Stefano Marcia2, Amedeo Taglieri1, Antonio Chiaravalloti1, Eros Calabria1, Mario Raguso3, Emanuele Piras2, Giovanni Simonetti1. 1. Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy. 2. UOC Unitá Operativa Complessa Radiologia, Ospedale SS, Santissima Trinitá, Cagliari, Italy. 3. Department of Diagnostic and Molecular Imaging, Interventional Radiology and Radiation Therapy, University of Rome 'Tor Vergata', Rome, Italy marioraguso@hotmail.it.
Abstract
PURPOSE: 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. MATERIALS AND 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.
PURPOSE: 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. MATERIALS AND 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.Patientpain 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: Kyle E Swanson; Derek P Lindsey; Ken Y Hsu; James F Zucherman; Scott A Yerby Journal: Spine (Phila Pa 1976) Date: 2003-01-01 Impact factor: 3.468
Authors: Steven J Atlas; Robert B Keller; Yen A Wu; Richard A Deyo; Daniel E Singer Journal: Spine (Phila Pa 1976) Date: 2005-04-15 Impact factor: 3.468
Authors: James F Zucherman; Ken Y Hsu; Charles A Hartjen; Thomas F Mehalic; Dante A Implicito; Michael J Martin; Donald R Johnson; Grant A Skidmore; Paul P Vessa; James W Dwyer; Stephen T Puccio; Joseph C Cauthen; Richard M Ozuna Journal: Spine (Phila Pa 1976) Date: 2005-06-15 Impact factor: 3.468
Authors: Eberhard Siebert; Harald Prüss; Randolf Klingebiel; Vieri Failli; Karl M Einhäupl; Jan M Schwab Journal: Nat Rev Neurol Date: 2009-07 Impact factor: 42.937
Authors: Jan Van Meirhaeghe; Patrick Fransen; Daniele Morelli; Niall J A Craig; Gregor Godde; Attila Mihalyi; Frederic Collignon Journal: Eur Spine J Date: 2012-05-08 Impact factor: 3.134