{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T07:26:41Z","timestamp":1791617201673,"version":"4.3.4"},"reference-count":49,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["SPI"],"published-print":{"date-parts":[[2013,11]]},"abstract":"\nObject<\/jats:title>\nCervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine.<\/jats:p><\/jats:sec>\n\nMethods<\/jats:title>\nThis study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients).<\/jats:p><\/jats:sec>\n\nResults<\/jats:title>\nA total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates.<\/jats:p><\/jats:sec>\n\nConclusions<\/jats:title>\nThe results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov<\/jats:ext-link>).<\/jats:p><\/jats:sec>","DOI":"10.3171\/2013.6.spine12527","type":"journal-article","created":{"date-parts":[[2013,9,6]],"date-time":"2013-09-06T13:54:12Z","timestamp":1378475652000},"page":"532-545","source":"Crossref","is-referenced-by-count":139,"title":["Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial"],"prefix":"10.3171","volume":"19","author":[{"given":"Reginald J.","family":"Davis","sequence":"first","affiliation":[{"name":"Greater Baltimore Neurosurgical Associates, Baltimore, Maryland;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kee D.","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Neurological Surgery, University of California, Davis, Sacramento, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S.","family":"Hisey","sequence":"additional","affiliation":[{"name":"Texas Back Institute, Plano, Texas;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory A.","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Orthopaedics Northeast, Fort Wayne, Indiana;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun W.","family":"Bae","sequence":"additional","affiliation":[{"name":"Cedars Sinai Spine Center, Los Angeles, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven E.","family":"Gaede","sequence":"additional","affiliation":[{"name":"Oklahoma Brain and Spine Institute, Tulsa, Oklahoma;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralph F.","family":"Rashbaum","sequence":"additional","affiliation":[{"name":"Texas Back Institute, Plano, Texas;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierce Dalton","family":"Nunley","sequence":"additional","affiliation":[{"name":"Spine Institute of Louisiana, Shreveport, Louisiana;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel L.","family":"Peterson","sequence":"additional","affiliation":[{"name":"Austin Brain and Spine, Austin; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John K.","family":"Stokes","sequence":"additional","affiliation":[{"name":"Seton Spine and Scoliosis Center, Austin, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1-spine12527","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2779","DOI":"10.1097\/01.brs.0000146460.11591.8a","article-title":"Intervertebral disc arthroplasty","volume":"29","author":"Anderson","year":"2004"},{"issue":"10 Suppl","key":"b2-spine12527","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"S427","DOI":"10.1097\/00007632-199210001-00014","article-title":"Modified Smith-Robinson procedure for anterior cervical discectomy and fusion","volume":"17","author":"Brodke","year":"1992"},{"key":"b3-spine12527","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1097\/00007632-198803000-00003","article-title":"Cervical stabilization by plate and bone fusion","volume":"13","author":"Brown","year":"1988"},{"key":"b4-spine12527","article-title":"Adjacent segment degeneration following ProDisc-C Total Disc Replacement (TDR) and Anterior Cervical Discectomy and Fusion (ACDF): does surgeon bias effect radiographic interpretation?","author":"Bui"},{"key":"b5-spine12527","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1016\/j.spinee.2010.02.007","article-title":"Neck Disability Index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion","volume":"10","author":"Carreon","year":"2010"},{"key":"b6-spine12527","series-title":"J Neurosurg Spine","doi-asserted-by":"publisher","first-page":"40","DOI":"10.3171\/SPI-07\/07\/040","article-title":"Range of motion change after cervical arthroplasty with ProDisc-C and prestige artificial discs compared with anterior cervical discectomy and fusion","volume":"7","author":"Chang","year":"2007"},{"key":"b7-spine12527","series-title":"J Neurosurg Spine","doi-asserted-by":"publisher","first-page":"348","DOI":"10.3171\/2011.5.SPINE10769","article-title":"Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up. 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