{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T09:00:57Z","timestamp":1780736457459,"version":"3.54.1"},"reference-count":40,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["FOC"],"published-print":{"date-parts":[[2017,2]]},"abstract":"\n OBJECTIVE<\/jats:title>\n The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)\u2013approved 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>\n <\/jats:sec>\n \n METHODS<\/jats:title>\n 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>\n <\/jats:sec>\n \n RESULTS<\/jats:title>\n In the single-level group, 4 of the 7 artificial discs\u2014Prestige LP, Prestige ST, Bryan, and Secure-C\u2014showed 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>\n <\/jats:sec>\n \n CONCLUSIONS<\/jats:title>\n 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>\n <\/jats:sec>","DOI":"10.3171\/2016.11.focus16414","type":"journal-article","created":{"date-parts":[[2017,2,1]],"date-time":"2017-02-01T03:38:34Z","timestamp":1485920314000},"page":"E2","source":"Crossref","is-referenced-by-count":23,"title":["Cervical arthroplasty: what does the labeling say?"],"prefix":"10.3171","volume":"42","author":[{"given":"Mazda K.","family":"Turel","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mena G.","family":"Kerolus","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Owoicho","family":"Adogwa","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent C.","family":"Traynelis","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1-focus16414","series-title":"J Neurosurg Spine","first-page":"516","article-title":"Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: clinical article","volume":"21","author":"Burkus","year":"2014"},{"key":"b2-focus16414","series-title":"SAS J","first-page":"122","article-title":"Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients","volume":"4","author":"Delamarter","year":"2010"},{"key":"b3-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"2673","article-title":"Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: single-level and bi-level","volume":"28","author":"Goffin","year":"2003"},{"key":"b4-focus16414","series-title":"J Neurosurg Spine","first-page":"558","article-title":"Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study","volume":"23","author":"Gornet","year":"2015"},{"key":"b5-focus16414","series-title":"J Neurosurg Spine","article-title":"Cervical disc arthroplasty at two levels with PRESTIGE LP Disc versus anterior cervical discectomy and fusion: results of a prospective, multicenter pivotal clinical trial at twenty-four months","author":"Gornet","year":"2016"},{"key":"b6-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"101","article-title":"Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial","volume":"34","author":"Heller","year":"2009"},{"key":"b7-focus16414","series-title":"Int J Spine Surg","first-page":"7","article-title":"Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine","volume":"8","author":"Hisey","year":"2014"},{"key":"b8-focus16414","series-title":"J Spinal Disord Tech","first-page":"E237","article-title":"Prospective, randomized comparison of cervical total disk replacement versus anterior cervical fusion: results at 48 months follow-up","volume":"28","author":"Hisey","year":"2015"},{"key":"b9-focus16414","series-title":"J Neurosurg Spine","first-page":"198","article-title":"Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial","volume":"6","author":"Mummaneni","year":"2007"},{"key":"b10-focus16414","series-title":"Spine J","first-page":"275","article-title":"Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease","volume":"9","author":"Murrey","year":"2009"},{"key":"b11-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"556","article-title":"Cervical disc replacement in patients with and without previous adjacent level fusion surgery: a prospective study","volume":"34","author":"Phillips","year":"2009"},{"key":"b12-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"E907","article-title":"A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial","volume":"38","author":"Phillips","year":"2013"},{"key":"b13-focus16414","series-title":"J Spinal Disord Tech","first-page":"221","article-title":"The intermediate clinical outcome and its limitations of Bryan cervical arthroplasty for treatment of cervical disc herniation","volume":"24","author":"Ren","year":"2011"},{"key":"b14-focus16414","series-title":"Orthopedics","first-page":"889","article-title":"Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial","volume":"34","author":"Sasso","year":"2011"},{"key":"b15-focus16414","series-title":"Spine (Phila Pa 1976)","article-title":"Long-term clinical outcomes of cervical disc arthroplasty: a prospective, randomized, controlled trial","author":"Sasso","year":"2016"},{"key":"b16-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"2227","article-title":"Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multi-center investigational device exemption study","volume":"38","author":"Vaccaro","year":"2013"},{"key":"b17-focus16414","series-title":"J Manip Physiol Ther","first-page":"409","article-title":"The Neck Disability Index: a study of reliability and validity","volume":"14","author":"Vernon","year":"1991"},{"key":"b18-focus16414","series-title":"Neurosurgery","first-page":"679","article-title":"Longitudinal prospective long-term radiographic follow-up after treatment of single-level cervical disk disease with the Bryan Cervical Disc","volume":"67","author":"Walraevens","year":"2010"},{"key":"b19-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"E371","article-title":"Early and intermediate follow-up results after treatment of degenerative disc disease with the Bryan cervical disc prosthesis: single-and multiple-level","volume":"33","author":"Yang","year":"2008"},{"key":"b20-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"203","article-title":"ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study","volume":"38","author":"Zigler","year":"2013"},{"key":"b1-focus16414","series-title":"J Neurosurg Spine","first-page":"516","article-title":"Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical 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disease","volume":"9","author":"Murrey","year":"2009"},{"key":"b11-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"556","article-title":"Cervical disc replacement in patients with and without previous adjacent level fusion surgery: a prospective study","volume":"34","author":"Phillips","year":"2009"},{"key":"b12-focus16414","series-title":"Spine (Phila Pa 1976)","first-page":"E907","article-title":"A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial","volume":"38","author":"Phillips","year":"2013"},{"key":"b13-focus16414","series-title":"J Spinal Disord Tech","first-page":"221","article-title":"The intermediate clinical outcome and its limitations of Bryan cervical arthroplasty for treatment of cervical disc 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