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Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion

BACKGROUND: The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumba...

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Autor principal: Geisler, Fred H.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: RRY Publications, LLC 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365567/
https://www.ncbi.nlm.nih.gov/pubmed/25802574
http://dx.doi.org/10.1016/SASJ-2006-0002-RR
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author Geisler, Fred H.
author_facet Geisler, Fred H.
author_sort Geisler, Fred H.
collection PubMed
description BACKGROUND: The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE) study led to a conclusion that clinical outcomes following lumbar arthroplasty were at least as good as outcomes from fusion. METHODS: The author performed a new analysis of the Visual Analog Scale pain scores and the Oswestry Disability Index scores from the Charité artificial disc IDE study and used a nonparametric statistical test, because observed data distributions were not normal. The analysis included all of the enrolled subjects in both the nonrandomized and randomized phases of the study. RESULTS: Subjects from both the treatment and control groups improved from the baseline situation (P < .001) at all follow-up times (6 weeks to 24 months). Additionally, these pain and disability levels with artificial disc replacement were superior (P < .05) to the fusion treatment at all follow-up times including 2 years. CONCLUSIONS: The a priori statistical plan for an IDE study may not adequately address the final distribution of the data. Therefore, statistical analyses more appropriate to the distribution may be necessary to develop meaningful statistical conclusions from the study. A nonparametric statistical analysis of the Charité artificial disc IDE outcomes scores demonstrates superiority for lumbar arthroplasty versus fusion at all follow-up time points to 24 months.
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spelling pubmed-43655672015-03-23 Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion Geisler, Fred H. SAS J Full Length Article BACKGROUND: The US Food and Drug Administration approved the Charité artificial disc on October 26, 2004. This approval was based on an extensive analysis and review process; 20 years of disc usage worldwide; and the results of a prospective, randomized, controlled clinical trial that compared lumbar artificial disc replacement to fusion. The results of the investigational device exemption (IDE) study led to a conclusion that clinical outcomes following lumbar arthroplasty were at least as good as outcomes from fusion. METHODS: The author performed a new analysis of the Visual Analog Scale pain scores and the Oswestry Disability Index scores from the Charité artificial disc IDE study and used a nonparametric statistical test, because observed data distributions were not normal. The analysis included all of the enrolled subjects in both the nonrandomized and randomized phases of the study. RESULTS: Subjects from both the treatment and control groups improved from the baseline situation (P < .001) at all follow-up times (6 weeks to 24 months). Additionally, these pain and disability levels with artificial disc replacement were superior (P < .05) to the fusion treatment at all follow-up times including 2 years. CONCLUSIONS: The a priori statistical plan for an IDE study may not adequately address the final distribution of the data. Therefore, statistical analyses more appropriate to the distribution may be necessary to develop meaningful statistical conclusions from the study. A nonparametric statistical analysis of the Charité artificial disc IDE outcomes scores demonstrates superiority for lumbar arthroplasty versus fusion at all follow-up time points to 24 months. RRY Publications, LLC 2007-02-01 /pmc/articles/PMC4365567/ /pubmed/25802574 http://dx.doi.org/10.1016/SASJ-2006-0002-RR Text en Copyright SAS - Spine Arthroplasty Society 2007 http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License, permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Full Length Article
Geisler, Fred H.
Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion
title Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion
title_full Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion
title_fullStr Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion
title_full_unstemmed Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion
title_short Surgical Treatment for Discogenic Low-Back Pain: Lumbar Arthroplasty Results in Superior Pain Reduction and Disability Level Improvement Compared With Lumbar Fusion
title_sort surgical treatment for discogenic low-back pain: lumbar arthroplasty results in superior pain reduction and disability level improvement compared with lumbar fusion
topic Full Length Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365567/
https://www.ncbi.nlm.nih.gov/pubmed/25802574
http://dx.doi.org/10.1016/SASJ-2006-0002-RR
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