Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data
STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: 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 Investigatio...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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SAGE Publications
2017
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5400198/ https://www.ncbi.nlm.nih.gov/pubmed/28451497 http://dx.doi.org/10.1177/2192568216688195 |
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author | Anderson, Paul A. Nassr, Ahmad Currier, Bradford L. Sebastian, Arjun S. Arnold, Paul M. Fehlings, Michael G. Mroz, Thomas E. Riew, K. Daniel |
author_facet | Anderson, Paul A. Nassr, Ahmad Currier, Bradford L. Sebastian, Arjun S. Arnold, Paul M. Fehlings, Michael G. Mroz, Thomas E. Riew, K. Daniel |
author_sort | Anderson, Paul A. |
collection | PubMed |
description | STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Cervical TDR appears to be as safe as or safer than ACDF at 2-year follow-up. |
format | Online Article Text |
id | pubmed-5400198 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-54001982017-04-27 Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data Anderson, Paul A. Nassr, Ahmad Currier, Bradford L. Sebastian, Arjun S. Arnold, Paul M. Fehlings, Michael G. Mroz, Thomas E. Riew, K. Daniel Global Spine J Articles STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Cervical TDR appears to be as safe as or safer than ACDF at 2-year follow-up. SAGE Publications 2017-04-01 2017-04 /pmc/articles/PMC5400198/ /pubmed/28451497 http://dx.doi.org/10.1177/2192568216688195 Text en © The Author(s) 2017 http://creativecommons.org/licenses/by-nc-nd/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License (http://www.creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Articles Anderson, Paul A. Nassr, Ahmad Currier, Bradford L. Sebastian, Arjun S. Arnold, Paul M. Fehlings, Michael G. Mroz, Thomas E. Riew, K. Daniel Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data |
title | Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data |
title_full | Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data |
title_fullStr | Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data |
title_full_unstemmed | Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data |
title_short | Evaluation of Adverse Events in Total Disc Replacement: A Meta-Analysis of FDA Summary of Safety and Effectiveness Data |
title_sort | evaluation of adverse events in total disc replacement: a meta-analysis of fda summary of safety and effectiveness data |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5400198/ https://www.ncbi.nlm.nih.gov/pubmed/28451497 http://dx.doi.org/10.1177/2192568216688195 |
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