Cargando…

Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc

BACKGROUND: Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. METHODS:...

Descripción completa

Detalles Bibliográficos
Autores principales: Holt, Richard T., Majd, Mohammed E., Isaza, Jorge E., Blumenthal, Scott L., McAfee, Paul C., Guyer, Richard D., Hochschuler, Stephen H., Geisler, Fred H., Garcia, Rolando, Regan, John J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: RRY Publications, LLC 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365564/
https://www.ncbi.nlm.nih.gov/pubmed/25802575
http://dx.doi.org/10.1016/SASJ-2006-0004-RR
_version_ 1782362240337313792
author Holt, Richard T.
Majd, Mohammed E.
Isaza, Jorge E.
Blumenthal, Scott L.
McAfee, Paul C.
Guyer, Richard D.
Hochschuler, Stephen H.
Geisler, Fred H.
Garcia, Rolando
Regan, John J.
author_facet Holt, Richard T.
Majd, Mohammed E.
Isaza, Jorge E.
Blumenthal, Scott L.
McAfee, Paul C.
Guyer, Richard D.
Hochschuler, Stephen H.
Geisler, Fred H.
Garcia, Rolando
Regan, John J.
author_sort Holt, Richard T.
collection PubMed
description BACKGROUND: Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. METHODS: In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. RESULTS: The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. CONCLUSIONS: The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study.
format Online
Article
Text
id pubmed-4365564
institution National Center for Biotechnology Information
language English
publishDate 2007
publisher RRY Publications, LLC
record_format MEDLINE/PubMed
spelling pubmed-43655642015-03-23 Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc Holt, Richard T. Majd, Mohammed E. Isaza, Jorge E. Blumenthal, Scott L. McAfee, Paul C. Guyer, Richard D. Hochschuler, Stephen H. Geisler, Fred H. Garcia, Rolando Regan, John J. SAS J Full Length Article BACKGROUND: Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. METHODS: In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. RESULTS: The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. CONCLUSIONS: The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study. RRY Publications, LLC 2007-02-01 /pmc/articles/PMC4365564/ /pubmed/25802575 http://dx.doi.org/10.1016/SASJ-2006-0004-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
Holt, Richard T.
Majd, Mohammed E.
Isaza, Jorge E.
Blumenthal, Scott L.
McAfee, Paul C.
Guyer, Richard D.
Hochschuler, Stephen H.
Geisler, Fred H.
Garcia, Rolando
Regan, John J.
Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
title Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
title_full Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
title_fullStr Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
title_full_unstemmed Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
title_short Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc
title_sort complications of lumbar artificial disc replacement compared to fusion: results from the prospective, randomized, multicenter us food and drug administration investigational device exemption study of the charité artificial disc
topic Full Length Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4365564/
https://www.ncbi.nlm.nih.gov/pubmed/25802575
http://dx.doi.org/10.1016/SASJ-2006-0004-RR
work_keys_str_mv AT holtrichardt complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT majdmohammede complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT isazajorgee complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT blumenthalscottl complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT mcafeepaulc complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT guyerrichardd complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT hochschulerstephenh complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT geislerfredh complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT garciarolando complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc
AT reganjohnj complicationsoflumbarartificialdiscreplacementcomparedtofusionresultsfromtheprospectiverandomizedmulticenterusfoodanddrugadministrationinvestigationaldeviceexemptionstudyofthechariteartificialdisc