TY - JOUR
T1 - Two-Year Clinical and Radiological Outcomes in Patients With Diabetes Undergoing Single-Level Anterior Cervical Discectomy and Fusion
AU - Arnold, Paul M.
AU - Vaccaro, Alexander R.
AU - Sasso, Rick C.
AU - Goulet, Benoit
AU - Fehlings, Michael G.
AU - Heary, Robert F.
AU - Janssen, Michael E.
AU - Kopjar, Branko
N1 - Funding Information:
The authors thank Tamara Kopjar and Karen Anderson who provided medical writing services on behalf of Nor Consult, LLC. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Cerapedics, Inc, provided research funding to investigator sites to conduct the Food and Drug Administration (FDA) Investigational Device Exemption trial, including the research departments of the authors of this manuscript. No funding was received for other purposes. Dr Kopjar and his company were contracted by Cerapedics, Inc, to design and manage the clinical study. The remaining authors report no other conflicts of interest, including consultancy agreements, royalties, gifts received, or intellectual property with regard to the products (i-Factor Bone Graft) or company (Cerapedics, Inc.) involved in this scientific investigation.
Publisher Copyright:
© The Author(s) 2020.
PY - 2021/5
Y1 - 2021/5
N2 - 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/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; 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.
AB - 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/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; 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.
KW - Neck Disability Index
KW - Short Form 36
KW - Visual Analog Scale
KW - anterior cervical discectomy and fusion (ACDF)
KW - cervical radiculopathy
KW - degenerative disc disorder
KW - diabetes mellitus
KW - prognostic study
UR - http://www.scopus.com/inward/record.url?scp=85086048483&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85086048483&partnerID=8YFLogxK
U2 - 10.1177/2192568220914880
DO - 10.1177/2192568220914880
M3 - Article
C2 - 32875918
AN - SCOPUS:85086048483
SN - 2192-5682
VL - 11
SP - 458
EP - 464
JO - Global Spine Journal
JF - Global Spine Journal
IS - 4
ER -