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Study Design: Retrospective database review., Objective: The aim of this study was to analyze revisions of CDAs reported to the MAUDE database., Summary of Background Data: Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs., Methods: The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared., Results: A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify., Conclusions: The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA., Level of Evidence: Level II., Competing Interests: C.A. is a consultant on the advisory board for Camber Spine Tech; a consultant for Centinel Spine Inc.; is in the advisory board, and has an ownership interest in Orthobond Corporation and Surgalign. D.R.L. is a consultant and on the advisory board for Choice Spine; is a consultant for Depuy Synthes; has ownership interest from Woven Orthopedic Technologies, Vestia Ventures MiRus Investment LLC, HS2 LLC, and ISPH II LLC; has research support from Medtronic Sofamor Danek USA Inc.; has royalties from Nuvasive Inc.; is on the advisory board and has ownership interest from Remedy Logic; is a consultant and has royalties from Stryker; is a consultant and has ownership interest from Viseon Inc. The remaining authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: We sought to characterize trends in demographics, comorbidities, and postoperative complications among patients undergoing primary and revision cervical disc replacement (pCDR/rCDR) procedures., Methods: In this retrospective database study, the Premier Healthcare database was queried from 2006 to 2019. Annual proportions or medians were calculated for patient and hospital characteristics, comorbidities, and postoperative complications associated with CDR surgery. Trends were assessed using linear regression analyses with year of service as the sole predictor., Results: A total of 16,178 pCDR and 758 rCDR cases were identified, with a median (IQR) age of 46 (39; 53) and 51 (43; 60) years among patients, respectively. The annual number of both procedures increased between 2006 and 2019, from 135 to 2220 for pCDR (p < 0.001), and from 17 to 49 for rCDR procedures (p < 0.001), with radiculopathy being the main indication for surgery in both groups. Mechanical failure was identified as a major indication for rCDR procedures with an increase over time (p = 0.002). Baseline patient comorbidity burden (p = 0.045) and complication rates (p < 0.001) showed an increase. For both procedures, an increase in outpatient surgeries and procedures performed in rural hospitals was seen (pCDR: p = 0.045; p = 0.006; rCDR: p = 0.028; p = 0.034)., Conclusion: PCDR and rCDR procedures significantly increased from 2006 to 2019. At the same time, comorbidity burden and complication rates increased, while procedures were more often performed in an outpatient and rural setting. The identification of these trends can help guide future practice and lead to further areas of research., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Anterior cervical discectomy and fusion (ACDF) has been considered the standard treatment for degenerative cervical disc disease; however, recent trials have shown comparable outcomes with cervical disc arthroplasty (CDA). This study aimed to observe disparities in treatment paradigms of single-level cervical disc diseases and compare inpatient outcomes between procedures., Methods: A retrospective cohort of patients treated for single-level cervical disc herniation or degeneration without myelopathy was queried from the Nationwide Inpatient Sample spanning 2012-2015. Multivariate logistic regression was performed to assess the effects of demographics, temporality of admission, and hospital characteristics on odds of receiving CDA versus ACDF. Propensity-score matching was performed to compare cost, length of stay (LOS), non-home discharge, and inpatient complications., Results: In total, 1028 CDAs and 44,374 ACDFs were performed for single-level cervical disc disease during 2012-2015. Matched comparison showed that while non-home discharges were not different between CDA and ACDF (P = 0.248), patients who received CDA had a 0.19-day shorter LOS (P < 0.001) and $4694 greater total cost (P < 0.001). There were no statistically significant differences in inpatient complication rates. Multivariate analysis showed that patients in the 26th-50th percentile, 51st-75th percentile, and 76th-100th percentile of median household income had greater odds of CDA compared with patients in the 0-25th percentile (odds ratio [OR] 1.35, P = 0.003; OR 1.31, P = 0.013; OR 1.34, P = 0.011, respectively). Patients with private insurance had greater odds of receiving CDA compared with patients on Medicare (OR 1.91, P < 0.001)., Conclusions: CDA was associated with shorter LOS but greater costs compared with ACDF. Patients with greater median income and private insurance were more likely to receive CDA., (Published by Elsevier Inc.)

Background Context: Cervical disc replacement (CDR) has increased in popularity over the past decade based on published outcomes from FDA IDE studies with narrowly defined inclusion and exclusion criteria. A low rate of complications was noted in these studies. The broader complication profile for CDR in widespread clinical practice has yet to be described., Purpose: To outline the complications reported to the FDA regarding commonly used CDR products STUDY DESIGN/SETTING: Retrospective database review PATIENT SAMPLE: Nationwide database of reported complications related to CDR products from patients across the country OUTCOME MEASURES: Complications related to CDR METHODS: We queried the MAUDE database and Alternative Summary Reporting (ASR) data files submitted between January 2005 to March 2020. The complications listed for seven FDA-approved CDR implants were analyzed. The entries in the databases were cataloged for complication type, date of entry, source of report, and whether the investigation was "complete". Reports that had too little information to extract relevant data were excluded., Results: There were 1,517 entries identified in the MAUDE database. After removal of duplicate entries and entries without sufficient information, there were 1,347 entries analyzed. The top five complications were (1) migration of implant (338 entries, 25.2%) (2) insertion problem/failure (312 entries, 23.3%) (3) neck pain (203 entries, 15.2%) (4) heterotopic ossification (108 entries, 8.1%) and (5) radiculopathy (90 entries, 8.1%). The number of analyzed implant-related MAUDE entries and most common implant-related complication for each implant was 209 entries for insertion problem/failure for Mobi-C; 158 entries for migration of implant for ProDisc-C; 154 entries for insertion problem/failure for Bryan cervical disc; 130 entries for migration of implant for Prestige cervical disc; 49 entries for migration of implant for PCM cervical disc; 12 entries for migration of implant for M6 and 10 entries for migration of implant for Secure-C. Only 263 entries (19.5%) were deemed "complete". Most entries were from the manufacturer/company representative/distributor (923 entries, 70%). There were no entries related to cervical disc replacement devices within the ASR data., Conclusions: The MAUDE database highlights complications related to CDR implants that may not be emphasized in currently published studies. It is important to understand this broad complication profile for CDR to ensure safe utilization of this new technology., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Healthcare readmissions are important causes of increased cost and have profound clinical impact. Thirty-day readmissions in spine surgery have been well documented. However, rates, causes, and outcomes are not well understood outside 30 d., Objective: To analyze 30- and 90-d readmissions for a retrospective cohort of anterior cervical discectomy and fusions (ACDF) and total disc replacement (TDR) for degenerative cervical conditions., Methods: The Nationwide Readmissions Database approximates 50% of all US hospitalizations with patient identifiers to track patients longitudinally. Patients greater than 18 yr old were identified. Rates of readmission for 30 and 90 d were calculated. Predictor variables, complications, outcomes, and costs were analyzed via univariate and multivariable analyses., Results: Between January and September 2013, 72 688 patients were identified. The 30- and 90-d readmission rates were 2.67% and 5.97%, respectively. The most prevalent reason for 30-d readmission was complication of medical/surgical care (20.3%), whereas for 90-d readmission it was degenerative spine etiology (19.2%). Common risk factors for 30- and 90-d readmission included older age, male gender, Medicare/Medicaid, prolonged initial length of stay, and various comorbidities. Unique risk factors for 30- and 90-d readmissions included adverse discharge disposition and mechanical implant-related complications, respectively. When comparing ACDF and TDR, ACDFs were associated with increased 90-d readmissions (6.0% vs 4.3%). The TDR cohort had a shorter length of stay, lower complication rate, and fewer adverse discharge dispositions., Conclusion: Identification of readmission causes and predictors is important to potentially allow for changes in periperative management. Decreasing readmissions would improve patient outcomes and reduce healthcare costs.

Study Design: Prospective, multicenter, randomized clinical trial., Objective: To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion., Summary of Background Data: The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial., Methods: Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years., Results: At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF., Conclusion: The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF., Level of Evidence: 1.

Study Design: Retrospective database analysis., Objective: To compare the perioperative patient characteristics, early postoperative outcomes, and costs between anterior cervical discectomy and fusion (ACDF) and cervical total disc replacement (TDR) in the United States., Summary of Background Data: Cervical TDR and ACDF are indicated to treat symptomatic cervical degenerative pathology. The epidemiology, complication rates, and the cost differences between the 2 surgical approaches are not well characterized., Methods: Data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project was queried from 2002 to 2009. Patients undergoing cervical TDR or ACDF of 1 to 2 levels were identified. Patient demographics, comorbidities, length of stay, costs, and the in-hospital complications were assessed. SPSS (version 20) was used for statistical analysis with χ test for categorical data and independent-samples t test for continuous data. A value of P ≤ 0.001 denoted statistical significance. Multinomial regression analysis was used to identify the independent risk for complications in the TDR cohort compared with the ACDF cohort., Results: There were 141,230 ACDF cases of 1 to 2 levels and 1830 cervical TDR cases identified in the Nationwide Inpatient Sample database. The ACDF cohort was older and demonstrated a greater comorbidity burden than the TDR group (P < 0.001). The ACDF-treated patients demonstrated a significantly greater length of stay than the TDR group (P < 0.001). In contrast, there were no significant differences in the incidence of postoperative complications, mortality, or hospital costs between the surgical cohorts. Multinomial regression did not demonstrate significant differences in the risk for postoperative complications between the surgical techniques., Conclusion: The ACDF cohort was significantly older and demonstrated a greater comorbidity burden that likely contributed to the greater length of stay when than the TDR cohort. Both cohorts demonstrated comparable incidences of early postoperative complications and costs. There were no significant differences in the risks for postoperative complications between the surgical cohorts. Further studies are warranted to characterize the long-term complications, costs, and patient outcomes between the 2 surgical techniques., Level of Evidence: 3.