Comparison of the safety of outpatient cervical disc replacement with inpatient cervical disc replacement: A protocol for a meta-analysis.

BACKGROUND: Cervical disc replacement (CDR) has been widely used as an effective treatment for cervical degenerative disc diseases in recent years. However, the cost of this procedure is very high and may bring a great economic burden to patients and the health care system. It is reported that outpatient procedures can reduce nearly 30% of the costs associated with hospitalization compared with inpatient procedures. However, the safety profile surrounding outpatient CDR remains poorly resolved. This study aims to evaluate the current evidence on the safety of outpatient CDR METHODS:: Four English databases were searched. The inclusion and exclusion criteria were developed according to the PICOS principle. The titles and abstracts of the records will be screened by 2 authors independently. Records that meet the eligibility criteria will be screened for a second time by reading the full text. An extraction form will be established for data extraction. Risk of bias assessment will be performed by 2 authors independently using Cochrane risk of bias tool or Newcastle-Ottawa scale. Data synthesis will be conducted using Stata software. Heterogeneity among studies will be assessed using I test. The funnel plot, Egger regression test, and Begg rank correlation test will be used to examine the publication bias. RESULTS: The results of this meta-analysis will be published in a peer-review journal. CONCLUSION: This will be the first meta-analysis that compares the safety of outpatient CDR with inpatient CDR. Our study will help surgeons fully understand the complications and safety profile surrounding outpatient CDR. OSF REGISTRATION NUMBER:: doi.org/10.17605/OSF.IO/3597Z.

Financial Aspects of Cervical Disc Arthroplasty: A Narrative Review of Recent Literature.

Recently, there has been significant interest in understanding the cost-effectiveness of treatments in spine surgery as health care systems in the United States move toward value-based care and alternative payment models. Previous studies have shown comparable outcomes of cervical disc arthroplasty (CDA) and anterior cervical discectomy fusion; however, there is a lack of consensus on the cost-effectiveness of CDA to support full adoption. Evidence of the limitations of these cost-analysis studies also exists in the literature, including industry funding, potential selection bias, and varying methods of calculating value. The goal of this narrative review is to provide an overview of the cost-effectiveness of CDA compared with anterior cervical discectomy and fusion, and potential limitations with cost-analysis studies in spine surgery.

Systematic Review of Cost-Effectiveness Analyses in U.S. Spine Surgery.

BACKGROUND: Increasing costs put the value of spine surgery under scrutiny. In health economics, cost-effectiveness analyses (CEA) are used to compare the value of competing procedures. However, inconsistent methodology prevents standardization and implementation of recommendations. The goal of this study is to perform a systematic review of all U.S. CEAs in spine surgery reported to date, highlight their strengths and weaknesses, and define metrics essential for high-quality CEAs. METHODS: We followed AMSTAR systematic review methods, identifying all U.S. spine surgery CEAs reported to March 2019 with a structured, reproducible search of PubMed, Embase, and the Tufts CEA Registry. RESULTS: We identified 40 CEA studies. Twelve (30%) used outcome data from a randomized controlled trial. To calculate costs, 22 (55%) used allowed charges but costing methods were often unclear or imprecise. Studies applying discounting had mean follow-up of 5.92 years compared with 3.00 years for studies without. Eleven of 15 (73%) cervical studies compared cervical disc arthroplasty with anterior cervical discectomy and fusion, finding cervical disc arthroplasty to be cost-effective (<$100,000/quality-adjusted life year) for 1-level and 2-level procedures. Eleven of 25 lumbar studies (44%) compared operative with nonoperative interventions for intervertebral disc herniation, lumbar stenosis, and lumbar spondylolisthesis. Lumbar studies comparing surgical with nonoperative intervention found surgery at least cost-effective for intervertebral disc herniation and lumbar stenosis, but cost-effective only for lumbar spondylolisthesis at 4 years follow-up. Most studies (70%) lacked appropriate sensitivity analyses. CONCLUSIONS: Costing methodology remains obscure and inconsistent and incremental cost-effectiveness ratio results incomparable. The language of costing methodology must be standardized and sensitivity analyses of outcome and cost inputs mandatory for publication.

Long-Term Comparison of Health Care Utilization and Reoperation Rates in Patients Undergoing Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion for Cervical Degenerative Disc Disease.

BACKGROUND: Thus study was a retrospective cohort analysis. Anterior cervical discectomy and fusion (ACDF) has been the gold-standard procedure for single-level degenerative disc disease (DDD). Recently, cervical disc arthroplasty (CDA) has become increasingly prevalent as an alternative intervention. OBJECTIVE: To examine the long-term costs and reoperation rates associated with CDA and ACDF for the treatment of single-level DDD. METHODS: In the present study, we performed a retrospective cohort analysis using the MarketScan database of patients who underwent either ACDF or CDA between 2007 and 2011 and had 5 years postsurgery follow-up. Outcomes related to the health care utilization, cost, and reoperation were analyzed after propensity score matching (PSM). RESULTS: Of 12,434 patients, 12,099 underwent ACDF and 335 CDA. Length of hospital stay and initial hospitalization cost was higher after ACDF compared with CDA. More patients undergoing CDA had early physical therapy compared with patients undergoing ACDF (CDA 30.15% vs. ACDF 22.39%; P = 0.0176). Five years after surgery, there was no significant difference in overall payments between patients undergoing ACDF and patients undergoing CDA. Reoperation rates were comparable at 5 years after the index procedure (CDA 8.06% vs. ACDF 9.25%; P = 0.5862). Patients who underwent ACDF showed decreased use of tramadol after surgery (15.09% before surgery vs. 9.55% after surgery; P < 0.0001). CONCLUSIONS: We found no difference in health care utilization between ACDF and CDA procedures for DDD 5 years after surgery. Also, there was no difference in reoperation rates during the study period. ACDF resulted in significant reduction in overall opioid use after versus before procedure.

Analysis of Outcomes and Cost of Inpatient and Ambulatory Anterior Cervical Disk Replacement Using a State-level Database.

BACKGROUND: Outpatient cervical artificial disk replacement (ADR) is a promising candidate for cost reduction. Several studies have demonstrated low overall complications and minimal readmission in anterior cervical procedures. OBJECTIVE: The objective of this study was to compare clinical outcomes and cost associated between inpatient and ambulatory setting ADR. MATERIALS AND METHODS: Outcomes and cost were retrospectively analyzed for patients undergoing elective ADR in California, Florida, and New York from 2009 to 2011 in State Inpatient and Ambulatory Databases. RESULTS: A total of 1789 index ADR procedures were identified in the inpatient database (State Inpatient Databases) compared with 370 procedures in the ambulatory cohort (State Ambulatory Surgery and Services Databases). Ambulatory patients presented to the emergency department 19 times (5.14%) within 30 days of the index procedure compared with 4.2% of inpatients. Four unique patients underwent readmission within 30 days in the ambulatory ADR cohort (1% total) compared with 2.2% in the inpatient ADR group. No ambulatory ADR patients underwent a reoperation within 30 days. Of the inpatient ADR group, 6 unique patients underwent reoperation within 30 days (0.34%, Charlson Comorbidity Index zero=0.28%, Charlson Comorbidity Index>0=0.6%). There was no significant difference in emergency department visit rate, inpatient readmission rate, or reoperation rates within 30 days of the index procedure between outpatient or inpatient ADR. Outpatient ADR is noninferior to inpatient ADR in all clinical outcomes. The direct cost was significantly lower in the outpatient ADR group ($11,059 vs. 17,033; P<0.001). The 90-day cumulative charges were significantly lower in the outpatient ADR group (mean $46,404.03 vs. $80,055; P<0.0001). CONCLUSIONS: ADR can be performed in an ambulatory setting with comparable morbidity, readmission rates, and lower costs, to inpatient ADR.

Cervical Artificial Disc Replacement Versus Fusion for Cervical Degenerative Disc Disease: A Health Technology Assessment.

BACKGROUND: Cervical degenerative disc disease is a multifactorial condition that begins with deterioration of the intervertebral disc and results in further degeneration within the spine involving the facet joints and ligaments. This health technology assessment examined the effectiveness, safety, durability, and cost-effectiveness of cervical artificial disc replacement (C-ADR) versus fusion for treating cervical degenerative disc disease. METHODS: We performed a systematic literature search of the clinical evidence comparing C-ADR with fusion. We assessed the risk of bias in each study and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic review of the economic literature and assessed the cost-effectiveness of C-ADR compared with fusion. We also estimated the budget impact of publicly funding C-ADR in Ontario over the next 5 years. To contextualize the potential value of C-ADR, we spoke with people with cervical degenerative disc disease. RESULTS: Eight studies of C-ADR for one-level cervical degenerative disc disease and two studies of C-ADR for two-level disease satisfied the criterion of statistical noninferiority compared with fusion on the primary outcome of 2-year overall treatment success (GRADE: Moderate). In two studies of C-ADR for two-level disease, C-ADR was statistically superior to fusion surgery for the same primary outcome (GRADE: Moderate). C-ADR was also noninferior to fusion for perioperative outcomes (e.g., operative time, blood loss), patient satisfaction, and health-related quality of life (GRADE: Moderate). C-ADR was superior to fusion for recovery and return to work, had higher technical success, and had lower rates of re-operation at the index site (GRADE: Moderate). C-ADR also maintained motion at the index-treated cervical level (GRADE: Moderate), but evidence was insufficient to determine if adjacent-level surgery rates differed between C-ADR and fusion. Current evidence is also insufficient to determine the long-term durability of C-ADR.The primary economic analysis shows that C-ADR is likely to be cost-effective compared with fusion for both one-level ($11,607/quality-adjusted life-year [QALY]) and two-level ($16,782/QALY) degeneration. Various sensitivity and scenario analyses confirm the robustness of the results. The current uptake for one-level and two-level C-ADR in Ontario is about 8% of the total eligible. For one-level involvement, the estimated net budget impact increases from $7,243 (18 procedures) in the first year to $395,623 (196 procedures) in the fifth year following public funding, for a total budget impact over 5 years of $916,326. For two-level involvement, the corresponding values are $5,460 (7 procedures) in the first year and $283,689 (76 procedures) in the fifth year, for an estimated total budget impact of $705,628 over 5 years.People with cervical degenerative disc disease reported that symptoms of pain and numbness can have a negative impact on their quality of life. People with whom we spoke had tried a variety of treatments with minor success; surgery was perceived as the most effective and permanent solution. Those who had undergone C-ADR spoke positively of its impact on their quality of life and ability to move their neck after surgery. The limited availability of C-ADR in Ontario was viewed as a barrier to receiving this treatment. CONCLUSIONS: For carefully selected patients with cervical degenerative disc disease, C-ADR provides patient-important and statistically significant reductions in pain and disability. Further, unlike fusion, C-ADR allows people to maintain relatively normal cervical spine motion.Compared with fusion, C-ADR appears to represent good value for money for adults with one-level cervical degenerative disc disease ($11,607/QALY) and for adults with two-level disease ($16,782/QALY). In Ontario, publicly funding C-ADR could result in total additional costs of $916,326 for one-level procedures and $705,628 for two-level procedures over the next 5 years.People with whom we spoke who had undergone C-ADR surgery spoke positively of its impact on their quality of life and ability to move their neck after surgery. The limited availability of C-ADR in Ontario was viewed as a barrier to receiving this treatment.

The Mobi-C® cervical disc and other devices for two-level disc replacement: overview of its safety and efficacy.

INTRODUCTION: Cervical disc arthroplasty (CDA) has become an acceptable alternative for anterior cervical discectomy and fusion (ACDF) for a significant patient population with cervical radiculopathy and/or myelopathy secondary to degenerative changes in the cervical spine. There are sufficient mid- and long-term data supporting performance and safety of one-level CDA. With the success of single-level cervical CDA, considerable interest exists about CDA use for multilevel cervical degenerative disc disease (DDD). This review analyzes the safety and efficacy of two-level CDA for treatment of symptomatic cervical DDD with focus on the Mobi-C® Cervical Disc. AREAS COVERED: This review summarizes previously published articles in a literature search using keywords: 'two-level-anterior cervical arthrodesis; two-level anterior cervical decompression and fusion (ACDF); two-level cervical disc arthroplasty (CDA); two-level cervical total disc replacement; two-level symptomatic degenerative disc disease (DDD); Mobi-C® disc'. EXPERT OPINION: Two-level CDA with the Mobi-C® device demonstrated equivalent, and in certain aspects, favorable outcomes compared to ACDF for treatment of symptomatic cervical 2-level degenerative disc disease (DDD) indicating a satisfactory safety and efficacy profile.

Value of Cervical Disk Arthroplasty.

Over the last decade, several of the Food and Drug Administration-regulated investigational device exemption (IDE) trials have compared multiple cervical disk arthroplasty (CDA) devices to anterior cervical decompression and fusion (ACDF) showing comparable and even superior patient-reported outcomes. CDA has been an increasingly attractive option because of the positive outcomes and the motion-preserving technology. However, with the large burden that health care expenditures place on the economy, the focus is now on the value of treatment options. Cost-effectiveness studies assess value by evaluating both outcomes and cost, and recently several have been conducted comparing CDA and ACDF. The results have consistently shown that CDA is a cost-effective alternative, however, in comparison to ACDF the results remain inconclusive. The lack of incorporation of disease specific measures into health state utility values, the inconsistent methods of calculating cost, and the fact that a vast majority of the results have come from industry-sponsored studies makes it difficult to form a definitive conclusion. Despite these limitations, both procedures have proven to be safe, effective, and cost-efficient alternatives.

What Factors Influence Reimbursement for 1 to 2 Level Anterior Cervical Discectomy and Fusion Procedures?

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine reimbursement associated with an anterior cervical discectomy and fusion (ACDF) and the demographic factors influencing reimbursement for an ACDF. SUMMARY OF BACKGROUND DATA: ACDF has been shown to be a cost-effective procedure. However, there has been minimal analysis of factors influencing reimbursement for this procedure. METHODS: Clinical and financial data were retrospectively reviewed for 176 patients undergoing an ACDF procedure in 2013 and 2014. Patients were included if they had primary ACDF and excluded if they were treated for a traumatic cervical spine fracture, infection, failed primary procedure, front/back procedure, or total disc replacement procedure. Clinical factors analyzed included number of levels fused, surgical time, length of stay in the hospital, estimated blood loss, implant type, Charleson Comorbidity Index (CCI), and preoperative diagnosis. Payer type and reimbursement associated with physician and hospital fees were collected for each patient. A multiple linear regression model determined the factors influencing reimbursement data using a backward conditional stepwise methodology. Variables were only included in multivariate analysis if there was a significant (P < 0.05) impact on reimbursement within univariate analysis. RESULTS: One hundred and twenty-eight patients met inclusion criteria. The average reimbursement per patient was $24,622 (+/- standard deviation of 14,616). The only significant factors influencing reimbursement was payer type (P < 0.001) and length of hospital stay (P < 0.001). These two independent multivariate determinants of reimbursement only accounted for 18.6% of reimbursement variability. CONCLUSION: There is substantial variability in reimbursement for ACDF procedures. Multivariate analysis indicates that payer type and length of hospital stay significantly influence reimbursement. Our model, however, only explained a small proportion of reimbursement variability indicating that factors outside our analysis may significantly affect hospital reimbursement. LEVEL OF EVIDENCE: 3.

The Seven-Year Cost-Effectiveness of Anterior Cervical Discectomy and Fusion Versus Cervical Disc Arthroplasty: A Markov Analysis.

STUDY DESIGN: Markov model analysis. OBJECTIVE: The aim of this study was to determine the 7-year cost-effectiveness of single-level anterior cervical discectomy and fusion (ACDF) versus cervical disc replacement (CDR) for the treatment of cervical disc degeneration. SUMMARY OF BACKGROUND DATA: Both ACDF and CDR are acceptable surgical options for the treatment of symptomatic cervical disc degeneration. Past studies have demonstrated at least equal effectiveness of CDR when compared with ACDF in large randomized Investigational Device Exemption (IDE) studies. Short-term cost-effectiveness analyses at 5 years have suggested that CDR may be the preferred treatment option. However, adjacent segment disease and other postoperative complications may occur after 5 years following surgery. METHODS: A Markov model analysis was used to evaluate data from the LDR Mobi-C IDE study, incorporating five Markov transition states and seven cycles with each cycle set to a length of 1 year. Transition state probabilities were determined from complication rates, as well as index and adjacent segment reoperation rates from the IDE study. Raw SF-12 data were converted to health state utility values using the SF-6D algorithm for 174 CDR patients and 79 ACDF patients. RESULTS: Assuming an ideal operative candidate who is 40-years-old and failed appropriate conservative care, the 7-year cost was $103,924 for ACDF and $105,637 for CDR. CDR resulted in the generation of 5.33 quality-adjusted life-years (QALYs), while ACDF generated 5.16 QALYs. Both ACDF and CDR were cost-effective, but the incremental cost-effectiveness ratio (ICER) was $10,076/QALY in favor of CDR, which was less than the willingness-to-pay (WTP) threshold of $50,000/QALY. CONCLUSION: ACDF and CDR are both cost-effective strategies for the treatment of cervical disc degeneration. However, CDR is the more cost-effective procedure at 7 years following surgery. Further long-term studies are needed to validate the findings of this model. LEVEL OF EVIDENCE: 1.

Cervical Total Disc Replacement and Anterior Cervical Discectomy and Fusion: Reoperation Rates, Complications, and Hospital Resource Utilization in 72 688 Patients in the United States.

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.

The 5-year cost-effectiveness of two-level anterior cervical discectomy and fusion or cervical disc replacement: a Markov analysis.

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) and cervical disc replacement (CDR) are both acceptable surgical options for the treatment of cervical myelopathy and radiculopathy. To date, there are limited economic analyses assessing the relative cost-effectiveness of two-level ACDF versus CDR. PURPOSE: The purpose of this study was to determine the 5-year cost-effectiveness of two-level ACDF versus CDR. STUDY DESIGN: The study design is a secondary analysis of prospectively collected data. PATIENT SAMPLE: Patients in the Prestige cervical disc investigational device exemption (IDE) study who underwent either a two-level CDR or a two-level ACDF were included in the study. OUTCOME MEASURES: The outcome measures were cost and quality-adjusted life years (QALYs). MATERIALS AND METHODS: A Markov state-transition model was used to evaluate data from the two-level Prestige cervical disc IDE study. Data from the 36-item Short Form Health Survey were converted into utilities using the short form (SF)-6D algorithm. Costs were calculated from the payer perspective. QALYs were used to represent effectiveness. A probabilistic sensitivity analysis (PSA) was performed using a Monte Carlo simulation. RESULTS: The base-case analysis, assuming a 40-year-old person who failed appropriate conservative care, generated a 5-year cost of $130,417 for CDR and $116,717 for ACDF. Cervical disc replacement and ACDF generated 3.45 and 3.23 QALYs, respectively. The incremental cost-effectiveness ratio (ICER) was calculated to be $62,337/QALY for CDR. The Monte Carlo simulation validated the base-case scenario. Cervical disc replacement had an average cost of $130,445 (confidence interval [CI]: $108,395-$152,761) with an average effectiveness of 3.46 (CI: 3.05-3.83). Anterior cervical discectomy and fusion had an average cost of $116,595 (CI: $95,439-$137,937) and an average effectiveness of 3.23 (CI: 2.84-3.59). The ICER was calculated at $62,133/QALY with respect to CDR. Using a $100,000/QALY willingness to pay (WTP), CDR is the more cost-effective strategy and would be selected 61.5% of the time by the simulation. CONCLUSIONS: Two-level CDR and ACDF are both cost-effective strategies at 5 years. Neither strategy was found to be more cost-effective with an ICER greater than the $50,000/QALY WTP threshold. The assumptions used in the analysis were strongly validated with the results of the PSA.

Barriers to and Budget Impact of Lumbar Total Disc Replacement Utilization.

: Evidence on the favorable efficacy, safety, and cost effectiveness of lumbar total disc replacement (TDR) compared with fusion for lumbar degenerative disc disease is mounting; however, a key barrier identified for TDR utilization is lack of coverage by US health insurers. Although economic considerations in a fee-for-service model should not be a determining factor in patient access, concerns regarding the budget impact of lumbar TDR surgery may unfortunately underlie coverage decisions. On the basis of the data available and economic modeling, the panel agreed that there is no indication that there would be a dramatic increase in patients seeking lumbar TDR. Considering several possible scenarios on potential growth in TDR utilization with coverage, as well as growth in the overall surgical pool of patients, economic modeling demonstrated that adoption of lumbar TDR would result in minimal or no budget impact for commercial insurance plans. Considering these model results and the economic literature, the panel concluded that adopting lumbar TDR within a coverage policy is expected to remain cost neutral for the insurer.

Is Total Disk Replacement a Cost-effective Treatment for Cervical Degenerative Disk Disease?

STUDY DESIGN: A retrospective study. OBJECTIVE: The objective of this study was to assess the cost-effectiveness and clinical outcome of motion-preserving versus fusion procedures in cervical spine surgery. SUMMARY OF BACKGROUND DATA: During the last decade there has been a huge growth in spine surgery with a concurrent increase in the economic burden. Currently, there appear to be no differences in clinical outcome between cervical total disk replacement (TDR) and spinal fusion (SF). For this reason it seems useful to know within the decision-making process whether there is a difference in actual cost between motion-preserving and fusion surgery. So far data that describe expenses involved in these procedures have not been available. This study offers a comparison of economic factors that should be considered in TDR and SF. MATERIALS AND METHODS: The German statutory general healthcare insurance (GHI) provides anonymized patient-related data of their customers. A retrospective query using the codes of surgery of all TDR and SF surgery was performed from January 2003 to June 2008. A total of 467 cases with monosegmental or bisegmental surgery for degenerative disk pathologies were included. RESULTS: Both groups showed significant differences in independent variables such as age and sex (P<0.0001), but not in revision rates. Cost weight of diagnosis-related groups and length of hospitalization had a significant effect on total costs. Both groups obtained less pain medication postoperatively than preoperatively without a significant difference between each group. Postoperative absenteeism from work was significantly higher in the TDR group;however, patients with TDR underwent less rehabilitation covered by the GHI. Both groups had the same amount of preoperative and postoperative physiotherapy covered by the GHI. CONCLUSIONS: According to the collected data, there are no differences between the medical outcomes of cervical TDR in comparison with cervical SF. At the same time, while generating clinical results comparable with spinal fusion, TDR incurred significantly lower costs. Therefore, both from the medical and from the financial point of view, TDR is a viable choice in the treatment of degenerative disk pathology.

Increased Utilization of Cervical Disk Arthroplasty in University Hospitals with Regional Variation and Socioeconomic Discrepancies.

OBJECTIVE: Treatment of cervical radiculopathy with disk arthroplasty has been approved by the U.S. Food and Drug Administration since 2007. Recently, a significant increase in clinical data including mid- and long-term follow-up has become available, demonstrating the superiority of disk arthroplasty compared with anterior discectomy and fusion. The aim of this project is to assess the nationwide use of cervical disk arthroplasty. METHODS: The University Healthcare Consortium database was accessed for all elective cases of patients treated for cervical radiculopathy caused by disk herniation (International Classification of Diseases [ICD] 722.0) from the fourth quarter of 2012 to the third quarter of 2015. Within this 3-year window, temporal and socioeconomic trends in the use of cervical disk replacement for this diagnosis were assessed. RESULTS: Three thousand four hundred forty-six cases were identified. A minority of cases (10.7%) were treated with disk arthroplasty. Median hospital charges were comparable for cervical disk replacement ($15,606) and anterior cervical fusion ($15,080). However, utilization was seen to increase by nearly 70% during the timeframe assessed. Disk arthroplasty was performed in 8% of patients in 2012 to 2013, compared with 13% of cases in 2015. Disk replacement use was more common for self-paying patients, patients with private insurance, and patients with military-based insurance. There was widespread variation in the use of cervical disk replacement between regions, with a nadir in northeastern states (8%) and a peak in western states (20%). CONCLUSION: Over a short, 3 -year period there has been an increase in the treatment of symptomatic cervical radiculopathy with disk arthroplasty. The authors predict a further increase in cervical disk arthroplasty in upcoming years.

Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up.

BACKGROUND: The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion. OBJECTIVE: Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years. METHODS: Data were derived from a randomized trial of 330 patients. Data from the 12-Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated quality-adjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate. RESULTS: The cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34 377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was -$165 103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50 000 per QALY in all scenarios (-$225 816 per QALY to $22 071 per QALY). CONCLUSION: This study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality. ABBREVIATIONS: ACDF, anterior cervical discectomy and fusionAWP, average wholesale priceCE, cost-effectivenessCEA, cost-effectiveness analysisCPT, Current Procedural TerminologycTDR, cervical total disc replacementCUA, cost-utility analysisDDD, degenerative disc diseaseDRG, diagnosis-related groupFDA, US Food and Drug AdministrationICER, incremental cost-effectiveness ratioIDE, Investigational Device ExemptionNDI, neck disability indexQALY, quality-adjusted life yearsRCT, randomized controlled trialRTW, return-to-workSF-12, 12-Item Short Form Health SurveyVAS, visual analog scaleWTP, willingness-to-pay.

Seven-year cost-effectiveness of ProDisc-C total disc replacement: results from investigational device exemption and post-approval studies.

OBJECTIVE The purpose of this study was to evaluate the 7-year cost-effectiveness of cervical total disc replacement (CTDR) versus anterior cervical discectomy and fusion (ACDF) for the treatment of patients with single-level symptomatic degenerative disc disease. A change in the spending trajectory for spine care is to be achieved, in part, through the selection of interventions that have been proven effective yet cost less than other options. This analysis complements and builds upon findings from other cost-effectiveness evaluations of CTDR through the use of long-term, patient-level data from a randomized study. METHODS This was a 7-year health economic evaluation comparing CTDR versus ACDF from the US commercial payer perspective. Prospectively collected health care resource utilization and treatment effects (quality-adjusted life years [QALYs]) were obtained from individual patient-level adverse event reports and SF-36 data, respectively, from the randomized, multicenter ProDisc-C total disc replacement investigational device exemption (IDE) study and post-approval study. Statistical distributions for unit costs were derived from a commercial claims database and applied using Monte Carlo simulation. Patient-level costs and effects were modeled via multivariate probabilistic analysis. Confidence intervals for 7-year costs, effects, and net monetary benefit (NMB) were obtained using the nonparametric percentile method from results of 10,000 bootstrap simulations. The robustness of results was assessed through scenario analysis and within a parametric regression model controlling for baseline variables. RESULTS Seven-year follow-up data were available for more than 70% of the 209 randomized patients. In the base-case analysis, CTDR resulted in mean per-patient cost savings of $12,789 (95% CI $5362-$20,856) and per-patient QALY gains of 0.16 (95% CI -0.073 to 0.39) compared with ACDF over 7 years. CTDR was more effective and less costly in 90.8% of probabilistic simulations. CTDR was cost-effective in 99.8% of sensitivity analysis simulations and generated a mean incremental NMB of $20,679 (95% CI $6053-$35,377) per patient at a willingness-to-pay threshold of $50,000/QALY. CONCLUSIONS Based on this modeling evaluation, CTDR was found to be more effective and less costly over a 7-year time horizon for patients with single-level symptomatic degenerative disc disease. These results are robust across a range of scenarios and perspectives and are intended to support value-based decision making.

Costs of cervical disc replacement versus anterior cervical discectomy and fusion for treatment of single-level cervical disc disease: an analysis of the Blue Health Intelligence database for acute and long-term costs and complications.

STUDY DESIGN: Retrospective review of prospectively collective administrative data. OBJECTIVE: The purpose of this study was to determine the reoperation rates, adverse event rate, as well as the direct and follow-on costs of cervical disc arthroplasty (CDA) compared with anterior cervical discectomy and fusion (ACDF) in a "real-world" population of patients with single-level symptomatic cervical disc disease. SUMMARY OF BACKGROUND DATA: Until very recently, there was a paucity of human clinical data to demonstrate that CDA lowers the rate of adjacent segment disease over ACDF. METHODS: This was a retrospective, matched cohort analysis of a prospectively collected database of costs and outcomes for patients aged 18 to 60 years, who were continuously enrolled in a Blue Cross Plan contributing data to a claims database. Inclusion criteria were as follows: all patients who were treated surgically with either CDA or ACDF between January 2008 and December 2009, with single-level cervical pathology and claims reflecting at least 6 weeks of nonsurgical preoperative care without claims history of prior surgery. RESULTS: There were 6635 ACDF patients and 327 CDA patients. There were no significant differences in the incidence of comorbidities or mean follow-up time (ACDF 25.7 mo vs. CDA 26.1 mo) between groups. By 36 months postoperatively, the reoperation rate was significantly increased in the ACDF group (10.5%) versus the CDA group (5.7%) (hazard ratio, P = 0.0214). The index surgery and 90-day global window costs were significantly lower in the CDA groups. At final follow-up, there was a statistically significant reduction in total costs paid by insurer in CDA patients (CDA $34,979 vs. ACDF $39,820). CONCLUSION: Patients who underwent CDA for single-level degenerative disease had lower readmission rates, lower reoperation rates, and reduced index and total costs than those treated with ACDF. CDA was effective in reducing the monthly cost of care compared with ACDF. LEVEL OF EVIDENCE: 2.

[Surgery for chronic low back pain: good option? Better than conservative treatment?]

The goal of this article is to assess, using the literature and our own experience, whether surgery is a reasonable option in the management of non-specific or degenerative chronic low back pain. The usual starting points for low back pain are without doubt the intervertebral disc and the facet joints, but the actual etiology is often difficult to determine. Moreover, psychogenic factors may amplify clinical symptoms. In our experience, thorough clinical, psychological, and socioprofessional assessment along with relevant imaging studies, parti- cularly MRI to look for inflammatory disc disease and EOS system to evaluate sagittal balance, leads to surgical indication in only 5 % of the patients with chronic low back pain. In these cases, surgery is aimed at short-circuiting ideally one, but sometimes two, interver- tebral segment by a conventional rigid fixation (arthrodesis), or by more recent non-rigid fixation techniques (disc replacement or interspinous dynamic stabilization). Their preven- tive effect on accelerated degeneration of adjacent segment appears to be moderate at best. The problem is to compare the results of surgical and conservative treatment: The analysis of publications concerning comparative randomized studies and personal studies shows that surgery is useful in only a small proportion of well selected patients with chronic low back pain, compared with physical and cognitive-behavioral management techniques.