title: Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial.
abstract: METHODS
  Randomized clinical trial with 2-year follow-up.
  
  
  OBJECTIVE
  To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis.
  
  
  BACKGROUND
  Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment.
  
  
  METHODS
  We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio.
  
  
  RESULTS
  The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886-3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: -0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700.
  
  
  CONCLUSIONS
  The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate.
  
  
  METHODS
  2.
authors.affiliation: *Department of Orthopedic Surgery, Innlandet Hospital Trust, Lillehammer, Norway †Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway ‡National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway §Department of Orthopedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway ¶Institute of Health Management and Health Economics, University of Oslo, Norway ‖Regional Centre for Child and Youth Mental Health and Child Welfare, Norwegian University of Science and Technology, Trondheim, Norway; and; and **Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Greger
authors.initials: G
authors.lastname: Lønne
authors.forename: Lars Gunnar
authors.initials: LG
authors.lastname: Johnsen
authors.forename: Eline
authors.initials: E
authors.lastname: Aas
authors.forename: Stian
authors.initials: S
authors.lastname: Lydersen
authors.forename: Hege
authors.initials: H
authors.lastname: Andresen
authors.forename: Roar
authors.initials: R
authors.lastname: Rønning
authors.forename: Øystein P
authors.initials: ØP
authors.lastname: Nygaard
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D019299:Decompression, Surgical / Q000191:economics* / Q000379:methods; D057239:Early Termination of Clinical Trials; D005260:Female; D005500:Follow-Up Studies; D017721:Hospital Costs; D006801:Humans; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000191:economics / Q000295:instrumentation / Q000379:methods; D019637:Orthopedic Procedures / Q000191:economics* / Q000295:instrumentation / Q000379:methods*; D019736:Prostheses and Implants / Q000191:economics; D019057:Quality-Adjusted Life Years; D012086:Reoperation; D013130:Spinal Stenosis / Q000601:surgery*