title: The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.
abstract: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion.
  
  
  
  This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level.
  
  
  
  There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty.
  
  
  
  The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty.
  
  
  
  http://www.clinicaltrials.gov NCT 00735176.19.
authors.affiliation: Department of Neurosurgery, Oslo University Hospital Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway. jarle.sundseth@rikshospitalet.no.|Faculty of Medicine, University of Oslo, Oslo, Norway. jarle.sundseth@rikshospitalet.no.
authors.forename: Jarle
authors.identifier: 0000-0002-8800-5302
authors.initials: J
authors.lastname: Sundseth
authors.affiliation: Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.|National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.|Department of Neuroscience, Faculty of Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Oddrun Anita
authors.initials: OA
authors.lastname: Fredriksli
authors.affiliation: Department of Neurosurgery, Oslo University Hospital Rikshospitalet, Postboks 4950 Nydalen, 0424, Oslo, Norway.
authors.forename: Frode
authors.initials: F
authors.lastname: Kolstad
authors.affiliation: National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.|Department of Neuroscience, Faculty of Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.|Department of Orthopaedic Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.
authors.forename: Lars Gunnar
authors.initials: LG
authors.lastname: Johnsen
authors.affiliation: Oslo Centre of Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Oslo, Norway.
authors.forename: Are Hugo
authors.initials: AH
authors.lastname: Pripp
authors.affiliation: National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.|Department of Neuroscience, Faculty of Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Hege
authors.initials: H
authors.lastname: Andresen
authors.affiliation: Department of Neurosurgery, Haukeland University Hospital, Bergen, Norway.
authors.forename: Erling
authors.initials: E
authors.lastname: Myrseth
authors.affiliation: Department of Neurosurgery, University Hospital of North Norway, Tromsø, Norway.
authors.forename: Kay
authors.initials: K
authors.lastname: Müller
authors.affiliation: Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.|National Advisory Unit on Spinal Surgery, St. Olavs Hospital, Trondheim University Hospital, Trondheim, Norway.|Department of Neuroscience, Faculty of Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Øystein P
authors.initials: ØP
authors.lastname: Nygaard
authors.affiliation: Faculty of Medicine, University of Oslo, Oslo, Norway. j.a.zwart@medisin.uio.no.|Department of Neurology and FORMI, Oslo University Hospital Ullevaal, Oslo, Norway. j.a.zwart@medisin.uio.no.
authors.forename: John-Anker
authors.initials: JA
authors.lastname: Zwart
mesh_terms: D000328:Adult; D001178:Arthroplasty; D002574:Cervical Vertebrae / Q000601:surgery*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009664:Norway; D061646:Operative Time; D010146:Pain / Q000209:etiology / Q000601:surgery; D011446:Prospective Studies; D011843:Radiculopathy / Q000601:surgery*; D012086:Reoperation / Q000706:statistics & numerical data; D016037:Single-Blind Method; D013123:Spinal Fusion
keywords: Arthroplasty; Cervical; Fusion; Outcome