Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Arnold PM

PROVIDER: S-EPMC8119920 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

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

Arnold Paul M PM Vaccaro Alexander R AR Sasso Rick C RC Goulet Benoit B Fehlings Michael G MG Heary Robert F RF Janssen Michael E ME Kopjar Branko B

Global spine journal 20200403 4

<h4>Study design</h4>Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study.<h4>Objective</h4>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.<h4>Methods</h4> ...[more]

PMID: 32875918

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Project description:BackgroundCervical disc arthroplasty (CDA) has emerged as an alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical pathologies. Studies are on-going to assess the long term outcomes of CDA. This study assessed the safety and efficacy of the Prestige(®) LP Disc at 84-months follow up.MethodsProspective data from 280 CDA patients with single-level cervical disc disease with radiculopathy or myelopathy were compared with 265 historical control ACDF patients. Clinical and radiographic follow up was completed pre-operatively, intraoperatively, and at intervals up to 84 months.ResultsFollow-up rate was 75.9% for CDA and 70.0% for ACDF patients. Statistical improvements (p < 0.001) in Neck Disability Index (NDI), neck/arm pain, and SF-36 were achieved by 1.5 months in both groups and maintained through 84 months. At 84 months, 86.1% of CDA versus 80.1% of ACDF patients achieved NDI success, (≥15-point improvement over baseline). Mean NDI score improvements exceeded 30 points in both groups. SF-36 PCS/MCS mean improvements were 13.1±11.9/8.2±12.3 points for CDA and 10.7±11.8/8.3±13.6 points for ACDF. Neurological success was 92.8% for CDA and 79.7% for ACDF patients. The rate of Overall Success was 74.9% for CDA and 63.2% for ACDF. At 84 months, 17.5% of CDA and 16.6% of ACDF patients had a possibly implant- or implant-surgical procedure-related adverse event. Eighteen (6.4%) CDA and 29 (10.9%) ACDF patients had a second surgery at the index level. In CDA patients, mean angular motion at the target level was maintained at 24 (7.5°) and 84 (6.9°) months. Bridging bone was reported in 5.9%/9.5%/10.2%/13.0% of CDA patients at 24/36/60/84 months. Change in mean preoperative angulation of the adjacent segment above/below the index level was1.06±4.39/1.25±4.06 for CDA and (-0.23)±5.37/1.25±5.07 for ACDF patients. At 84 months, 90.9% of CDA and 85.6% of ACDF patients were satisfied with the results of their treatment.ConclusionsPrestige LP maintained significantly improved clinical outcomes and segmental motion; statistical superiority of CDA was concluded for overall success. This investigational device exemption study was sponsored by Medtronic Spinal and Biologics, Memphis, TN. Study approved by the Hughston Sports Medicine Center Institutional Review Board on January 7, 2005. Clinical trial registered at clinicaltrials.gov: NCT00667459. All participants signed an informed consent.

Project description:BackgroundPostoperative readmissions are a commonly used metric for quality-of-care initiatives, but emergency department (ED) visits have received far less attention despite their substantial impact on patient satisfaction and healthcare spending. The current study described the incidence and timing of ED visits following single-level ACDF, determined predictive factors and reasons for ED utilization, and compared reimbursement for patients with and without ED use.MethodsSingle-level ACDF procedures from 2010-2020 were identified in PearlDiver using CPT codes. Patients' age, sex, Elixhauser comorbidity index (ECI) score, region of the country, and insurance coverage were extracted. The incidence, timing, and primary diagnoses for 90-day ED visits and readmissions were determined, as well as total 90-day reimbursement. Variables were compared using univariate analysis and multivariate logistic regression.ResultsOut of 90,298 patients, 90-day ED visits were identified for 10,701 (11.9%), with the greatest incidence in postoperative weeks 1-2. Readmissions were identified for 3,325 (3.7%) patients. Independent predictors of ED utilization included younger age (OR 1.25 per 10-year decrease, p<0.001), greater ECI score (OR 1.40 per 2-point increase, p<0.001), and insurance type (relative to Medicare, Medicaid [OR 2.15, p<0.001] and commercial plans [OR 1.14, p=0.004]). In postoperative weeks 1-2, 51% of primary ED diagnoses involved the surgical site, while 23% involved the surgical site in weeks 3-13. Compared to patients without ED visits, those who visited the ED had 65% greater mean 90-day reimbursement (p<0.001).ConclusionsMore than three times as many patients in the current study were found to present to the ED than be readmitted within ninety days of surgery. The identified predictive factors and reasons for ED visits can direct attention to high-risk patients and common postoperative issues. Additional postoperative counseling and integrated care pathways may reduce ED visits, thereby improving patient care and reducing healthcare spending.

Dataset Information

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

Study design

Objective

Methods

Results

Conclusions

Publications

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

Similar Datasets

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