title: Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.
abstract: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF.
  
  
  
  The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed.
  
  
  
  Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study.
  
  
  
  NTR5536, pre-results.
authors.affiliation: Department of Neurosurgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: A E H
authors.initials: AE
authors.lastname: Broekema
authors.affiliation: Department of Neurosurgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.|University of Groningen, University Medical Center Groningen, Groningen Spine Center, Groningen, The Netherlands.
authors.forename: J M A
authors.initials: JM
authors.lastname: Kuijlen
authors.affiliation: Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: G A T
authors.initials: GA
authors.lastname: Lesman-Leegte
authors.affiliation: Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.
authors.forename: R H M A
authors.initials: RH
authors.lastname: Bartels
authors.affiliation: Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.|Department of Pharmacy, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: A D I
authors.initials: AD
authors.lastname: van Asselt
authors.affiliation: Department of Neurology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: P C A J
authors.initials: PC
authors.lastname: Vroomen
authors.affiliation: Department of Neurosurgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: J M C
authors.identifier: 0000-0002-0814-5680
authors.initials: JM
authors.lastname: van Dijk
authors.affiliation: Department of Rehabilitation, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: M F
authors.initials: MF
authors.lastname: Reneman
authors.affiliation: University of Groningen, University Medical Center Groningen, Groningen Spine Center, Groningen, The Netherlands.|Saxion University of Applied Sciences Enschede, Enschede, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Soer
authors.affiliation: Department of Neurosurgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: R J M
authors.initials: RJ
authors.lastname: Groen
mesh_terms: D002574:Cervical Vertebrae; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D017586:Diskectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods; D005500:Follow-Up Studies; D059526:Foraminotomy / Q000009:adverse effects / Q000191:economics; D006801:Humans; D011788:Quality of Life; D011843:Radiculopathy / Q000191:economics* / Q000601:surgery*; D012107:Research Design; D016037:Single-Blind Method; D013123:Spinal Fusion / Q000009:adverse effects / Q000191:economics; D016896:Treatment Outcome
keywords: anterior cervical discectomy; cervical radiculopathy; cost-effectiveness; foraminotomy; randomised controlled trial