{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,10]],"date-time":"2026-11-10T15:24:30Z","timestamp":1794324270591,"version":"4.9.0"},"reference-count":23,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["SPI"],"published-print":{"date-parts":[[2012,3]]},"abstract":"<jats:sec>\n                    <jats:title>Object<\/jats:title>\n                    <jats:p>There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26\u00b0 and postoperatively 8.14\u00b0) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I\n                      <jats:sup>2<\/jats:sup>\n                      = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I\n                      <jats:sup>2<\/jats:sup>\n                      = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I\n                      <jats:sup>2<\/jats:sup>\n                      = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3171\/2011.6.spine10623","type":"journal-article","created":{"date-parts":[[2011,12,23]],"date-time":"2011-12-23T09:57:35Z","timestamp":1324634255000},"page":"216-228","source":"Crossref","is-referenced-by-count":118,"title":["Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials"],"prefix":"10.3171","volume":"16","author":[{"given":"Cheerag D.","family":"Upadhyaya","sequence":"first","affiliation":[{"name":"1Departments of Neurological Surgery and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jau-Ching","family":"Wu","sequence":"additional","affiliation":[{"name":"1Departments of Neurological Surgery and"},{"name":"2Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital, National Yang-Ming University, Taipei, Taiwan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory","family":"Trost","sequence":"additional","affiliation":[{"name":"7Department of Neurological Surgery, University of Wisconsin Hospital & Clinics, Madison, Wisconsin"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regis W.","family":"Haid","sequence":"additional","affiliation":[{"name":"3Atlanta Brain & Spine, Atlanta, Georgia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincent C.","family":"Traynelis","sequence":"additional","affiliation":[{"name":"4Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bobby","family":"Tay","sequence":"additional","affiliation":[{"name":"5Orthopedic Surgery, University of California, San Francisco, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Domagoj","family":"Coric","sequence":"additional","affiliation":[{"name":"6Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Praveen V.","family":"Mummaneni","sequence":"additional","affiliation":[{"name":"1Departments of Neurological Surgery and"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2006.4.1.31"},{"key":"b2-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2007.6.4.2"},{"key":"b3-spine10623","doi-asserted-by":"publisher","DOI":"10.1097\/00006123-200209000-00048"},{"key":"b4-spine10623","doi-asserted-by":"publisher","DOI":"10.1097\/01.BRS.0000099392.90849.AA"},{"key":"b5-spine10623","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e31818ee263"},{"key":"b6-spine10623","doi-asserted-by":"publisher","DOI":"10.2106\/00004623-199904000-00009"},{"key":"b7-spine10623","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2009.313"},{"key":"b8-spine10623","doi-asserted-by":"crossref","first-page":"298","DOI":"10.7326\/0003-4819-144-4-200602210-00013","volume":"144","author":"Ioannidis JP","year":"2006","journal-title":"Ann Intern Med"},{"key":"b9-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/2010.3.FOCUS1046"},{"key":"b10-spine10623","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b2700"},{"key":"b11-spine10623","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2004.07.022"},{"key":"b12-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2007.6.3.198"},{"key":"b13-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2004.1.2.0155"},{"issue":"4","key":"b14-spine10623","first-page":"310","volume":"60","author":"Mummaneni PV","year":"2007","journal-title":"Neurosurgery"},{"key":"b15-spine10623","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2008.05.006"},{"key":"b16-spine10623","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e31813162d8"},{"key":"b17-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/SPI-07\/09\/336"},{"key":"b18-spine10623","doi-asserted-by":"publisher","DOI":"10.1016\/j.spinee.2004.07.024"},{"key":"b19-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/foc.2004.17.3.6"},{"key":"b20-spine10623","doi-asserted-by":"publisher","DOI":"10.4263\/jorthoptic.37.71"},{"key":"b21-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2005.3.5.0335"},{"key":"b22-spine10623","doi-asserted-by":"publisher","DOI":"10.3171\/SPI\/2008\/8\/6\/529"},{"key":"b23-spine10623","first-page":"328","volume":"46","author":"Wang Y","year":"2008","journal-title":"Zhonghua Wai Ke Za Zhi"}],"container-title":["Journal of Neurosurgery: Spine"],"original-title":[],"link":[{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/16\/3\/article-p216.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/16\/3\/article-p216.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,11,6]],"date-time":"2020-11-06T18:20:41Z","timestamp":1604686841000},"score":1,"resource":{"primary":{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/16\/3\/article-p216.xml"}},"subtitle":["Clinical article"],"short-title":[],"issued":{"date-parts":[[2012,3]]},"references-count":23,"journal-issue":{"issue":"3"},"URL":"https:\/\/doi.org\/10.3171\/2011.6.spine10623","relation":{},"ISSN":["1547-5654"],"issn-type":[{"value":"1547-5654","type":"print"}],"subject":[],"published":{"date-parts":[[2012,3]]}}}