title: Cervical arthroplasty: what does the labeling say?
abstract: OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)-approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs-Prestige LP, Prestige ST, Bryan, and Secure-C-showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.
authors.affiliation: Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois.
authors.forename: Mazda K
authors.initials: MK
authors.lastname: Turel
authors.affiliation: Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois.
authors.forename: Mena G
authors.initials: MG
authors.lastname: Kerolus
authors.affiliation: Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois.
authors.forename: Owoicho
authors.initials: O
authors.lastname: Adogwa
authors.affiliation: Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois.
authors.forename: Vincent C
authors.initials: VC
authors.lastname: Traynelis
mesh_terms: D002574:Cervical Vertebrae / Q000601:surgery*; D006801:Humans; D013122:Spinal Diseases / Q000601:surgery*; D059145:Total Disc Replacement / Q000295:instrumentation* / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
keywords: ACDF = anterior cervical discectomy and fusion; FDA = Food and Drug Administration; FSU = functional spinal unit; Food and Drug Administration; IDE = investigational device exemption; NDI = Neck Disability Index; anterior cervical discectomy and fusion; cervical arthroplasty