{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T11:15:06Z","timestamp":1793704506902,"version":"4.5.1"},"reference-count":20,"publisher":"SAGE Publications","issue":"1_suppl","license":[{"start":{"date-parts":[[2017,4,1]],"date-time":"2017-04-01T00:00:00Z","timestamp":1491004800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Global Spine Journal"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:sec>\n                    <jats:title>Study Design:<\/jats:title>\n                    <jats:p>Systematic review and meta-analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>The safety of new technology such as cervical total disc replacement (TDR) is of paramount importance and is best evaluated in randomized clinical trials (RCT). We compared complication risks of TDR to fusion using data from Investigational Device Exemptions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A systematic review of FDA Summary of Safety and Effectiveness reports of the 8 approved cervical TDRs was performed. These were all randomized controlled trials comparing anterior cervical discectomy and fusion (ACDF) to TDR. Important outcome variables were dysphagia, wound infection, neurologic injuries, heterotopic ossification, death, and secondary surgeries. A random effects model was selected a priori. Data on adverse events was abstracted and analyzed by calculating relative risk of ACDF to TDR by meta-analysis techniques.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The study included 3027 patients with 1377 randomized to ACDF and 1652 to TDR. No statistical differences were present between the 2 groups in dysphagia\/dysphonia, hardware related, heterotopic ossification, death, and overall neurologic adverse events and incidence of neurologic deterioration. The relative risk of wound-related problems ACDF to TDR was 0.76 (95% confidence interval [CI] = 0.59, 0.98) favoring ACDF, which was statistically significant, but these were minor and never required a second surgical procedure for deep wound infection. The relative risk of ACDF to TDR in surgical-related neurologic events and secondary surgeries was 1.62 (95% CI = 1.04, 2.53) and 1.79 (95% CI = 1.17, 2.74), both favoring TDR.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Cervical TDR appears to be as safe as or safer than ACDF at 2-year follow-up.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/2192568216688195","type":"journal-article","created":{"date-parts":[[2017,4,19]],"date-time":"2017-04-19T14:33:02Z","timestamp":1492612382000},"page":"76S-83S","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":22,"title":["Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data"],"prefix":"10.1177","volume":"7","author":[{"given":"Paul A.","family":"Anderson","sequence":"first","affiliation":[{"name":"University of Wisconsin, Madison, WI, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Nassr","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradford L.","family":"Currier","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arjun S.","family":"Sebastian","sequence":"additional","affiliation":[{"name":"Mayo Clinic, Rochester, MN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul M.","family":"Arnold","sequence":"additional","affiliation":[{"name":"Kansas University Medical Center, Kansas City, KS, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael G.","family":"Fehlings","sequence":"additional","affiliation":[{"name":"Toronto Western Hospital, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas E.","family":"Mroz","sequence":"additional","affiliation":[{"name":"Cleveland Clinic, Cleveland, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K. Daniel","family":"Riew","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"},{"name":"New York-Presbyterian\/The Allen Hospital, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2017,4,19]]},"reference":[{"key":"bibr1-2192568216688195","doi-asserted-by":"publisher","DOI":"10.1097\/BRS.0b013e31818ee263"},{"key":"bibr2-2192568216688195","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1016\/j.spinee.2008.05.006","volume":"9","author":"Murrey D","year":"2009","journal-title":"Spine J"},{"key":"bibr3-2192568216688195","doi-asserted-by":"publisher","DOI":"10.3171\/spi.2007.6.3.198"},{"key":"bibr4-2192568216688195","doi-asserted-by":"publisher","DOI":"10.7326\/M13-0480"},{"key":"bibr5-2192568216688195","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2013-003436"},{"key":"bibr6-2192568216688195","first-page":"287","volume":"63","author":"Anderson PA","year":"2014","journal-title":"Instr Course Lect"},{"key":"bibr7-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. PRESTIGE\u00ae Cervical Disc System\u2014P060018. http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfTopic\/pma\/pma.cfm?num=P060018. Accessed January 3, 2017."},{"key":"bibr8-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. ProDisc-C\u2122 Total Disc Replacement\u2014P070001. http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cftopic\/pma\/pma.cfm?num=p070001. Accessed January 3, 2017."},{"key":"bibr9-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. Bryan Cervical Disc\u2014P060023. http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfTopic\/pma\/pma.cfm?num=P060023. Accessed January 3, 2017."},{"key":"bibr10-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. SECURE-C\u00ae Artificial Cervical Disc\u2014P100003. http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cftopic\/pma\/pma.cfm?num=p100003. Accessed January 3, 2017."},{"key":"bibr11-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. PCM-C\u00ae Artificial Cervical Disc\u2014P100012. http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfTopic\/pma\/pma.cfm?num=P100012. Accessed January 3, 2017."},{"key":"bibr12-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. Mobi-C\u00ae Artificial Cervical Disc. http:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf11\/P110002B.pdf. Accessed January 3, 2017."},{"key":"bibr13-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. Mobi-C\u00ae Artificial Cervical Disc\u2014Two level. http:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf11\/P110009B.pdf. Accessed January 3, 2017."},{"key":"bibr14-2192568216688195","unstructured":"Food and Drug Administration. Summary of Safety and Effectiveness Data. Prestige\u00ae LP Artificial Cervical Disc. http:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf9\/P090029b.pdf. 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