Cervical arthroplasty: what does the labeling say?

Abstract

<jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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.</jats:p></jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>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.</jats:p></jats:sec>

Comparison of 10‐year Outcomes of Bryan Cervical Disc Arthroplasty for Myelopathy and Radiculopathy

“…The cervical artificial disc as a motion‐preserving prosthesis was used for cervical disc arthroplasty from the 1970s. Over the past 20 years, with the rapid development of materials science and cervical biomechanics research, many different designed types (unconstrained, semi‐constrained, and constrained) and different materials (metal to metal, metal to plastic) cervical artificial disc prosthesis have emerged. Cervical disc arthroplasty could maintain the physiological mobility, anatomical disc space height and normal segmental alignment of the operated level.…”

Desarrollo mecánico y experimental de un implante discal cervical flexible

“…Por otro lado, la manufactura aditiva por láser, también cono-cida como LAM, por sus siglas en inglés, es una relativamente novedosa técnica para elaborar piezas metálicas de uso en cirugía y teniendo en cuenta los detalles específicos en su tratamiento, puede ser perfectamente utilizada para la creación de implantes discales (26,27) . Adicionalmente, la adición de aleación de titanio (ELI) ha demostrado ser el tipo que posee mayor límite de fatiga, siendo un material bioinerte, con excelente resistencia a la corrosión, que puesto en una superficie ósea crea una intercara cerámica bioinerte que permite un excelente anclaje al tejido óseo vecino (28) .…”

“…Existen en la actualidad cinco tipos de aleaciones de titanio de uso médico que varían entre sí por su contenido de impurezas como el nitrógeno, carbono, hidrógeno, hierro y oxígeno. El aluminio le brinda a la aleación la tendencia a estabilizar la fase alfa, mientras que el vanadio estabiliza la fase beta como se evidenció en nuestro estudio metalográfico; además, la delgada capa de óxido, compacta y adherente, estabiliza el material y bajo condiciones fisiológicas determina una velocidad de corrosión muy baja (28) .…”

Financial Aspects of Cervical Disc Arthroplasty: A Narrative Review of Recent Literature

“…[1][2][3] Currently, indications for CDA include patients with either single or two-level cervical myelopathy or radiculopathy, who have failed conservative treatment, with limited instability and decreased degree of kyphosis. [4][5][6][7][8][9][10] The initial Federal Drug and Administration (FDA) Investigation Device Exemption (IDE) trials demonstrated positive clinical outcomes of CDA compared to ACDF in patients with cervical myelopathy and/or radiculopathy. 5,6,9,[11][12][13][14][15] Additionally, long-term follow-up studies have demonstrated favorable results of arthroplasty, particularly in terms of pain, disability, neurological status and patient satisfaction.…”