title: Minimally invasive decompression versus open laminectomy for central stenosis of the lumbar spine: pragmatic comparative effectiveness study.
abstract: OBJECTIVE
  To test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis.
  
  
  METHODS
  Multicentre observational study.
  
  
  METHODS
  Prospective data from the Norwegian Registry for Spine Surgery.
  
  
  METHODS
  885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011.
  
  
  METHODS
  Laminectomy and microdecompression.
  
  
  METHODS
  The primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts.
  
  
  RESULTS
  The study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval -1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003).
  
  
  CONCLUSIONS
  At one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups.Trial registration ClinicalTrials.gov NCT02006901.
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Ulf S
authors.initials: US
authors.lastname: Nerland
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden National Advisory Unit in Ultrasound and Image-Guided Surgery, St Olavs University Hospital, Trondheim, Norway.
authors.forename: Asgeir S
authors.initials: AS
authors.lastname: Jakola
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit in Ultrasound and Image-Guided Surgery, St Olavs University Hospital, Trondheim, Norway.
authors.forename: Ole
authors.initials: O
authors.lastname: Solheim
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit on Spinal Surgery Center for Spinal Disorders, St Olavs University Hospital, Trondheim, Norway.
authors.forename: Clemens
authors.initials: C
authors.lastname: Weber
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Vidar
authors.initials: V
authors.lastname: Rao
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway Department of Orthopedics, Innlandet Hospital Trust, Brumunddal, Norway.
authors.forename: Greger
authors.initials: G
authors.lastname: Lønne
authors.affiliation: Department of Neurosurgery, University Hospital of Northern Norway, Tromsø, Norway The Norwegian National Registry for Spine Surgery, University Hospital of Northern Norway), Tromsø, Norway.
authors.forename: Tore K
authors.initials: TK
authors.lastname: Solberg
authors.affiliation: Unit for Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Øyvind
authors.initials: Ø
authors.lastname: Salvesen
authors.affiliation: Unit for Applied Clinical Research, Norwegian University of Science and Technology, Trondheim, Norway Department of Endocrinology, St Olavs University Hospital, Trondheim, Norway.
authors.forename: Sven M
authors.initials: SM
authors.lastname: Carlsen
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit on Spinal Surgery Center for Spinal Disorders, St Olavs University Hospital, Trondheim, Norway.
authors.forename: Øystein P
authors.initials: ØP
authors.lastname: Nygaard
authors.affiliation: Department of Neurosurgery, St Olavs University Hospital, Trondheim, Norway Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway National Advisory Unit on Spinal Surgery Center for Spinal Disorders, St Olavs University Hospital, Trondheim, Norway Norwegian Centre of Competence in Deep Brain Stimulation for Movement Disorders, St Olavs University Hospital, Trondheim, Norway sashagulati@hotmail.com.
authors.forename: Sasha
authors.initials: S
authors.lastname: Gulati
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D057186:Comparative Effectiveness Research; D019299:Decompression, Surgical / Q000379:methods*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007796:Laminectomy; D008159:Lumbar Vertebrae / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D015233:Models, Statistical; D057216:Propensity Score; D011446:Prospective Studies; D011788:Quality of Life; D012042:Registries; D013130:Spinal Stenosis / Q000601:surgery*; D016896:Treatment Outcome
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