title: A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis.
abstract: BACKGROUND
  The efficacy of fusion surgery in addition to decompression surgery in patients who have lumbar spinal stenosis, with or without degenerative spondylolisthesis, has not been substantiated in controlled trials.
  
  
  METHODS
  We randomly assigned 247 patients between 50 and 80 years of age who had lumbar spinal stenosis at one or two adjacent vertebral levels to undergo either decompression surgery plus fusion surgery (fusion group) or decompression surgery alone (decompression-alone group). Randomization was stratified according to the presence of preoperative degenerative spondylolisthesis (in 135 patients) or its absence. Outcomes were assessed with the use of patient-reported outcome measures, a 6-minute walk test, and a health economic evaluation. The primary outcome was the score on the Oswestry Disability Index (ODI; which ranges from 0 to 100, with higher scores indicating more severe disability) 2 years after surgery. The primary analysis, which was a per-protocol analysis, did not include the 14 patients who did not receive the assigned treatment and the 5 who were lost to follow-up.
  
  
  RESULTS
  There was no significant difference between the groups in the mean score on the ODI at 2 years (27 in the fusion group and 24 in the decompression-alone group, P=0.24) or in the results of the 6-minute walk test (397 m in the fusion group and 405 m in the decompression-alone group, P=0.72). Results were similar between patients with and those without spondylolisthesis. Among the patients who had 5 years of follow-up and were eligible for inclusion in the 5-year analysis, there were no significant differences between the groups in clinical outcomes at 5 years. The mean length of hospitalization was 7.4 days in the fusion group and 4.1 days in the decompression-alone group (P<0.001). Operating time was longer, the amount of bleeding was greater, and surgical costs were higher in the fusion group than in the decompression-alone group. During a mean follow-up of 6.5 years, additional lumbar spine surgery was performed in 22% of the patients in the fusion group and in 21% of those in the decompression-alone group.
  
  
  CONCLUSIONS
  Among patients with lumbar spinal stenosis, with or without degenerative spondylolisthesis, decompression surgery plus fusion surgery did not result in better clinical outcomes at 2 years and 5 years than did decompression surgery alone. (Funded by an Uppsala institutional Avtal om Läkarutbildning och Forskning [Agreement concerning Cooperation on Medical Education and Research] and others; Swedish Spinal Stenosis Study ClinicalTrials.gov number, NCT01994512.).
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Försth
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Gylfi
authors.initials: G
authors.lastname: Ólafsson
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Thomas
authors.initials: T
authors.lastname: Carlsson
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Frost
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Fredrik
authors.initials: F
authors.lastname: Borgström
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Fritzell
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Patrik
authors.initials: P
authors.lastname: Öhagen
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Karl
authors.initials: K
authors.lastname: Michaëlsson
authors.affiliation: From the Department of Surgical Sciences, Division of Orthopedics (P. Försth, T.C., P. Fritzell, K.M., B.S.), and the Uppsala Clinical Research Center (P.Ö., K.M.), Uppsala University, Uppsala, Stockholm Spine Center (P. Försth, A.F.), the Department of Learning, Informatics, Management, and Ethics, Karolinska Institutet (G.Ó., F.B.), and Quantify Research (G.Ó., F.B.), Stockholm, and Futurum-Academy for Health and Care, Neuro-orthopedic Center, Ryhov (P. Fritzell) - all in Sweden.
authors.forename: Bengt
authors.initials: B
authors.lastname: Sandén
mesh_terms: D000368:Aged; D019299:Decompression, Surgical; D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D057194:Intention to Treat Analysis; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology; D011859:Radiography; D012086:Reoperation / Q000706:statistics & numerical data; D013123:Spinal Fusion; D013130:Spinal Stenosis / Q000150:complications / Q000601:surgery*; D013168:Spondylolisthesis / Q000150:complications / Q000601:surgery; D016896:Treatment Outcome