Cargando…

Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion

STUDY DESIGN: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. OBJECTIVE: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. W...

Descripción completa

Detalles Bibliográficos
Autores principales: Arnold, Paul M., Vaccaro, Alexander R., Sasso, Rick C., Goulet, Benoit, Fehlings, Michael G., Heary, Robert F., Janssen, Michael E., Kopjar, Branko
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119920/
https://www.ncbi.nlm.nih.gov/pubmed/32875918
http://dx.doi.org/10.1177/2192568220914880
_version_ 1783691957383462912
author Arnold, Paul M.
Vaccaro, Alexander R.
Sasso, Rick C.
Goulet, Benoit
Fehlings, Michael G.
Heary, Robert F.
Janssen, Michael E.
Kopjar, Branko
author_facet Arnold, Paul M.
Vaccaro, Alexander R.
Sasso, Rick C.
Goulet, Benoit
Fehlings, Michael G.
Heary, Robert F.
Janssen, Michael E.
Kopjar, Branko
author_sort Arnold, Paul M.
collection PubMed
description STUDY DESIGN: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. OBJECTIVE: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. METHODS: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. RESULTS: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m(2); SD = 5.72) and 284 without (average BMI = 28.32 kg/m(2); SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline (P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. CONCLUSIONS: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.
format Online
Article
Text
id pubmed-8119920
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher SAGE Publications
record_format MEDLINE/PubMed
spelling pubmed-81199202021-05-21 Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion Arnold, Paul M. Vaccaro, Alexander R. Sasso, Rick C. Goulet, Benoit Fehlings, Michael G. Heary, Robert F. Janssen, Michael E. Kopjar, Branko Global Spine J Original Articles STUDY DESIGN: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. OBJECTIVE: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. METHODS: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. RESULTS: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m(2); SD = 5.72) and 284 without (average BMI = 28.32 kg/m(2); SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline (P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. CONCLUSIONS: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD. SAGE Publications 2020-04-03 2021-05 /pmc/articles/PMC8119920/ /pubmed/32875918 http://dx.doi.org/10.1177/2192568220914880 Text en © The Author(s) 2020 https://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 (https://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 Original Articles
Arnold, Paul M.
Vaccaro, Alexander R.
Sasso, Rick C.
Goulet, Benoit
Fehlings, Michael G.
Heary, Robert F.
Janssen, Michael E.
Kopjar, Branko
Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
title Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
title_full Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
title_fullStr Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
title_full_unstemmed Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
title_short Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
title_sort two-year clinical and radiological outcomes in patients with diabetes undergoing single-level anterior cervical discectomy and fusion
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119920/
https://www.ncbi.nlm.nih.gov/pubmed/32875918
http://dx.doi.org/10.1177/2192568220914880
work_keys_str_mv AT arnoldpaulm twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT vaccaroalexanderr twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT sassorickc twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT gouletbenoit twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT fehlingsmichaelg twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT hearyrobertf twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT janssenmichaele twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion
AT kopjarbranko twoyearclinicalandradiologicaloutcomesinpatientswithdiabetesundergoingsinglelevelanteriorcervicaldiscectomyandfusion