title: One-year follow-up of a series of 100 patients treated for lumbar spinal canal stenosis by means of HeliFix interspinous process decompression device.
abstract: OBJECTIVE
  New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). HeliFix is a minimally invasive IPD that can be implanted percutaneously. This is a preliminary evaluation of safety and effectiveness of this IPD up to 12 months after implantation.
  
  
  METHODS
  After percutaneous implantation in 100 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months.
  
  
  RESULTS
  Early symptoms and physical function improvements were maintained for up to 12 months. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 2% of patients due to lack of effectiveness.
  
  
  CONCLUSIONS
  Overall, in a period of up to 12-month follow-up, the safety and effectiveness of the HeliFix offered a minimally invasive option for the relief of NIC complaints in a high proportion of patients. Further studies are undertaken in order to provide insight on outcomes and effectiveness compared to other decompression methods and to develop guidance on optimal patient selection.
authors.affiliation: European Neurosurgical Institute (EUNI), Via Chira 2, 31100 Treviso, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Alexandre
authors.affiliation: Istituto di Radiologia, Università Cattolica, Largo A. Gemelli, 00100 Rome, Italy.
authors.forename: Andrea Maria
authors.initials: AM
authors.lastname: Alexandre
authors.affiliation: European Neurosurgical Institute (EUNI), Via Chira 2, 31100 Treviso, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: De Pretto
authors.affiliation: European Neurosurgical Institute (EUNI), Via Chira 2, 31100 Treviso, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Corò
authors.affiliation: Istituto di Fisiatria, Università di Chieti, Via dei Vestini 31, 66100 Chieti, Italy.
authors.forename: Raul
authors.initials: R
authors.lastname: Saggini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000453:epidemiology / Q000601:surgery; D019299:Decompression, Surgical / Q000295:instrumentation* / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D019736:Prostheses and Implants; D013115:Spinal Canal / Q000601:surgery*; D013130:Spinal Stenosis / Q000601:surgery*; D016896:Treatment Outcome