A prospective study of lumbar facet arthroplasty in the treatment of degenerative spondylolisthesis and stenosis: cost-effective assessment from the Total Posterior Spine system (TOPSTM) IDE Study: 2-year model revision and sensitivity analyses based on 305 subjects.

BACKGROUND CONTEXT: A previous cost-effectiveness analysis published in 2022 found that the Total Posterior Spine (TOPSTM) system was dominant over transforaminal lumbar interbody fusion (TLIF). This analysis required updating to reflect a more complete dataset and pricing considerations. PURPOSE: To evaluate the cost-effectiveness of TOPSTM system as compared with TLIF based on an updated and complete FDA investigational device exemption (IDE) data set. STUDY DESIGN/SETTING: Cost-utility analysis of the TOPSTM system compared to TLIF. PATIENT SAMPLE: A multicenter, FDA IDE, randomized control trial (RCT) investigated the efficacy of TOPSTM compared to TLIF with a current population of n=305 enrolled and n=168 with complete 2-year follow-up. OUTCOME MEASURES: Cost and quality adjusted life years (QALYs) were calculated to determine our primary outcome measure, the incremental cost-effectiveness ratio. Secondary outcome measures included: net monetary benefit as well at willingness-to-pay (WTP) thresholds. METHODS: The primary outcome of cost-effectiveness is determined by incremental cost-effectiveness ratio. A Markov model was used to simulate the health outcomes and costs of patients undergoing TOPSTM or TLIF over a 2-year period. alternative scenario sensitivity analysis, one-way sensitivity analysis, and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. RESULTS: The updated base case result demonstrated that TOPSTM was immediately and longitudinally dominant compared with the control with an incremental cost-effectiveness ratio of -9,637.37 $/QALY. The net monetary benefit was correspondingly $2,237, both from the health system's perspective and at a WTP threshold of 50,000 $/QALY at the 2-year time point. This remained true in all scenarios tested. The Alternative Scenario Sensitivity Analysis suggested cost-effectiveness irrespective of payer type and surgical setting. To remain cost-effective, the cost difference between TOPSTM and TLIF should be no greater than $1,875 and $3,750 at WTP thresholds of $50,000 and 100,000 $/QALY, respectively. CONCLUSIONS: This updated analysis confirms that the TOPSTM device is a cost-effective and economically dominant surgical treatment option for patients with lumbar stenosis and degenerative spondylolisthesis compared to TLIF in all scenarios examined.

Lumbar Decompression With and Without Fusion for Lumbar Stenosis With Spondylolisthesis: A Cost Utility Analysis.

STUDY DESIGN: Markov model. OBJECTIVE: To compare the cost-effectiveness of lumbar decompression alone (DA) with lumbar decompression with fusion (DF) for the management of adults undergoing surgery for lumbar stenosis with associated degenerative spondylolisthesis. SUMMARY OF BACKGROUND DATA: Rates of lumbar fusion have increased for all indications in the United States over the last 20 years. Recent randomized controlled trial data, however, have suggested comparable functional outcomes and lower reoperation rates for lumbar decompression and fusion as compared with DA in the treatment of lumbar stenosis with degenerative spondylolisthesis. MATERIALS AND METHODS: A multistate Markov model was constructed from the US payer perspective of a hypothetical cohort of patients with lumbar stenosis with associated spondylolisthesis requiring surgery. Data regarding clinical improvement, costs, and reoperation were generated from contemporary randomized trial evidence, meta-analyses of recent prospective studies, and large retrospective cohorts. Base case, one-way sensitivity analysis, and probabilistic sensitivity analyses were conducted, and the results were compared with a WTP threshold of $100,000 (in 2022 USD) over a two-year time horizon. A discount rate of 3% was utilized. RESULTS: The incremental cost and utility of DF relative to DA were $12,778 and 0.00529 aggregated quality adjusted life years. The corresponding incremental cost-effectiveness ratio of $2,416,281 far exceeded the willingness to pay threshold of $100,000. In sensitivity analysis, the results varied the most with respect to rate of improvement after DA, rate of improvement after lumbar decompression and fusion, and odds ratio of reoperation between the two groups. Zero percent of one-way and probabilistic sensitivity analyses achieved cost-effectiveness at the willingness-to-pay threshold. CONCLUSIONS: Within the context of contemporary surgical data, DF is not cost-effective compared with DA in the surgical management of lumbar stenosis with associated spondylolisthesis over a two-year time horizon.

Direct medical costs after surgical or nonsurgical treatment for degenerative lumbar spinal disease: A nationwide matched cohort study with a 10-year follow-up.

OBJECTIVE: The demand for treating degenerative lumbar spinal disease has been increasing, leading to increased utilization of medical resources. Thus, we need to understand how the budget of insurance is currently used. The objective of the present study is to overview the utilization of the National Health Insurance Service (NHIS) by providing the direct insured cost between patients receiving surgery and patients receiving nonsurgical treatment for degenerative lumbar disease. METHODS: The NHIS-National Sample Cohort was utilized to select patients with lumbar disc herniation, spinal stenosis, spondylolisthesis or spondylolysis. A matched cohort study design was used to show direct medical costs of surgery (n = 2,698) and nonsurgical (n = 2,698) cohorts. Non-surgical treatment included medication, physiotherapy, injection, and chiropractic. The monthly costs of the surgery cohort and nonsurgical cohort were presented at initial treatment, posttreatment 1, 3, 6, 9, and 12 months and yearly thereafter for 10 years. RESULTS: The characteristics and matching factors were well-balanced between the matched cohorts. Overall, surgery cohort spent $50.84/patient/month, while the nonsurgical cohort spent $29.34/patient/month (p<0.01). Initially, surgery treatment led to more charge to NHIS ($2,762) than nonsurgical treatment ($180.4) (p<0.01). Compared with the non-surgical cohort, the surgery cohort charged $33/month more for the first 3 months, charged less at 12 months, and charged approximately the same over the course of 10 years. CONCLUSION: Surgical treatment initially led to more government reimbursement than nonsurgical treatment, but the charges during follow-up period were not different. The results of the present study should be interpreted in light of the costs of medical services, indirect costs, societal cost, quality of life and societal willingness to pay in each country. The monetary figures are implied to be actual economic costs but those in the reimbursement system instead reflect reimbursement charges from the government.

Long-Term Costs of Maximum Nonoperative Treatments in Patients With Symptomatic Lumbar Stenosis or Spondylolisthesis that Ultimately Required Surgery: A 5-Year Cost Analysis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The purpose of this study is to characterize the utilization and costs of MNTs prior to spinal fusion surgery in patients with symptomatic lumbar stenosis or spondylolisthesis. SUMMARY OF BACKGROUND DATA: The costs and utilization of long-term maximal nonoperative therapy (MNT) can be substantial, and in the current era of bundled payments, the duration of conservative therapy trials should be reassessed. METHODS: A large insurance database was queried for patients with symptomatic lumbar stenosis or spondylolisthesis undergoing index lumbar decompression and fusion procedures between 2007 and 2016. This database consists of 20.9 million covered lives and includes private/commercially insured and Medicare Advantage beneficiaries. Only patients with lumbar stenosis or spondylolisthesis and those continuously active within the insurance system for at least 5 years prior to the index operation were eligible. RESULTS: A total of 4133 out of 497,822 (0.8%) eligible patients underwent 1, 2, or 3-level posterior lumbar instrumented fusion. 20.8% of patients were smokers, 44.5% had type II DM, and 38.2% were obese (body mass index [BMI] >30 kg/m). Patient MNT utilization was as follows: 66.7% used nonsteroidal anti-inflammatory drugs (NSAIDs), 84.4% used opioids, 58.6% used muscle relaxants, 65.5% received lumbar epidural steroid injections (LESI), 66.6% attended 21.1% presented to the emergency department (ED), and 24.9% received chiropractor treatments. The total direct cost associated with all MNT prior to index spinal fusion was $9,000,968; LESI comprised the largest portion of the total cost of MNT ($4,094,646, 45.5%), followed by NSAIDS ($1,624,217, 18.0%) and opioid costs ($1,279,219, 14.2%). At the patient level, when normalized per patient utilizing therapy, an average $4010 was spent on nonoperative treatments prior to index lumbar surgery. CONCLUSION: Assuming minimal improvement in pain and functional disability after maximum nonoperative therapies, the incremental cost-effectiveness ratio (ICER) for MNTs could be highly unfavorable. LEVEL OF EVIDENCE: 3.

Analysis of Cost and 30-Day Outcomes in Single-Level Transforaminal Lumbar Interbody Fusion and Less Invasive, Stand-Alone Lateral Transpsoas Interbody Fusion.

BACKGROUND: A comparative evaluation of operative costs between single-level transforaminal interbody fusion (TLIF) and stand-alone lateral transpsoas interbody fusion (LIF) has not yet been done. We analyzed the costs, operative parameters, and early outcomes of single-level stand-alone LIF versus single-level TLIF. METHODS: Ten patients who underwent single-level TLIF and 10 patients who underwent single-level stand-alone LIF were included in the analysis. Total, variable, and fixed costs from perioperative data were available from a single institution. In addition, patient demographics, length of hospital stay, and 30-day outcomes and readmission rates were reviewed. RESULTS: Total cost, variable cost, and fixed costs were significantly lower in the LIF group, and there was no difference in outcomes. CONCLUSIONS: Single-level stand-alone LIF may prove to be more cost-effective and provide cost savings with analogous 30-day outcomes compared with single-level TLIF procedures.

Gender Differences in Use of Prolonged Nonoperative Therapies Before Index Lumbar Surgery.

OBJECTIVE: The purpose of the present study was to assess for gender-based differences in the usage and cost of maximal nonoperative therapy before spinal fusion surgery in patients with symptomatic lumbar stenosis or spondylolisthesis. METHODS: A large insurance database was queried for patients with symptomatic lumbar stenosis or spondylolisthesis undergoing index lumbar decompression and fusion procedures from 2007 to 2016. This database consists of 20.9 million covered lives and includes private or commercially insured and Medicare Advantage beneficiaries. Only patients continuously active within the Humana insurance system for ≥5 years before the index operation were eligible. Usage was characterized by the cost billed to the patient, prescriptions written, and number of units billed. RESULTS: A total of 4133 patients (58.5% women) underwent 1-, 2-, or 3-level posterior lumbar instrumented fusion. A significantly greater percentage of female patients used nonsteroidal anti-inflammatory drugs (P < 0.0001), lumbar epidural steroid injections (P = 0.0044), physical and/or occupational therapy (P < 0.0001), and muscle relaxants (P < 0.0001). The total direct cost associated with all maximal nonoperative therapy before index spinal fusion was $9,000,968, with men spending $3,451,479 ($2011.35 per patient) and women spending $5,549,489 ($2296.02 per patient). When considering the quantity of units billed, women used 61.5% of the medical therapy units disbursed despite constituting 58.5% of the cohort. When normalized by the number of pills billed per patient using therapy, female patients used more nonsteroidal anti-inflammatory drugs, opioids, and muscle relaxants. CONCLUSIONS: These results suggest that gender differences exist in the use of nonoperative therapies for symptomatic lumbar stenosis or spondylolisthesis before fusion surgery.

Health care utilization and overall costs based on opioid dependence in patients undergoing surgery for degenerative spondylolisthesis.

OBJECTIVE Opioid abuse is highly prevalent in patients with back pain. The aim of this study was to identify health care utilization and overall costs associated with opioid dependence in patients undergoing surgery for degenerative spondylolisthesis (DS). METHODS The authors queried the MarketScan database using ICD-9 and CPT-4 codes from 2000 to 2012. Opioid dependency was defined as having a diagnosis of opioid use disorder, having a prescription for opioid use disorder, or having 10 or more opioid prescriptions. Opioid dependency was evaluated in 12-month period leading to surgery and in the period 3-15 months following the procedure. Patients were segregated into 4 groups based on opioid dependence before and after surgery: group NDND (prior nondependent who remain nondependent), group NDD (prior nondependent who become dependent), group DND (prior dependent who become nondependent), and group DD (prior dependent who remain dependent). The outcomes of interest were discharge disposition, hospital length of stay (LOS), complications, and health care resource costs. The 4 groups were compared using the Kruskal-Wallis test and linear contrasts built from generalized regression models. RESULTS A total of 10,708 patients were identified, with 81.57%, 3.58%, 8.54%, and 6.32% of patients in groups NDND, NDD, DND, and DD, respectively. In group DD, 96.31% of patients had decompression with fusion, compared with 93.59% in group NDND. Patients in group NDD, DND, and DD had longer hospital LOS compared with those in group NDND. Patients in group DD were less likely to be discharged home compared with those in group NDND (odds ratio 0.639, 95% confidence interval 0.52-0.785). At 3-15 months postdischarge, patients in group DD incurred 21% higher hospital readmission costs compared with those in group NDND. However, patients in groups NDD and DD were likely to incur 2.8 times the overall costs compared with patients in group NDND (p < 0.001) at 3-15 months after surgery (median overall payments: group NDD $20,033 and group DD $19,654, vs group NDND $7994). CONCLUSIONS Patients who continued to be opioid dependent or became opioid dependent following surgery for DS incurred significantly higher health care utilization and costs within 3 months and in the period 3-15 months after discharge from surgery.

Postoperative Opioid Use, Complications, and Costs in Surgical Management of Lumbar Spondylolisthesis.

STUDY DESIGN: Retrospective analysis on a national longitudinal database (2007-2014). OBJECTIVE: To determine the association between arthrodesis and complication rates, costs, surgical revision, and postoperative opioid prescription. SUMMARY OF BACKGROUND DATA: Arthrodesis in patients receiving laminectomy for lumbar spondylolisthesis remains controversial. However, population-level evidence to support the use of arthrodesis remains limited. METHODS: We identified 73,176 patient records and used coarsened exact matching to create comparable populations of patients who received laminectomy or laminectomy with arthrodesis. We use linear and logistic regression models to analyze the relationship between arthrodesis and postoperative complications, length of stay, costs, readmissions, surgical revisions, and postoperative opioid prescribing. RESULTS: Patients who underwent arthrodesis spent 1 more day in the hospital on average (P < 0.01), and had higher costs of care at their index visit ($24,126, P < 0.01), which were partially offset by lower costs of care over the 2 years following their procedure ($14,667 less in arthrodesis patients, P = 0.01). Patients with arthrodesis were less likely to have a surgical revision (odds ratio = 0.66, P < 0.01). Patients with arthrodesis used more opioids in the first 2 months following their procedure, but had comparable opioid use to patients undergoing laminectomy without arthrodesis in all other postoperative months over the next 2 years, and were not more or less likely to convert to chronic opioid use. Postoperative opioid prescription varied dramatically across states (P < 0.01); geographic variation in opioid use is substantially greater than differences in opioid use based on procedure performed. CONCLUSION: Arthrodesis is associated with reduced likelihood of surgical revision and increased use of opioids in the first 2 months following surgery, but not associated with greater or lesser opioid use beyond the initial 2 postoperative months. Geographic variation in opioid use is substantial even after accounting for patient characteristics and for whether patients underwent arthrodesis. LEVEL OF EVIDENCE: 3.

A protocol of a randomized controlled multicenter trial for surgical treatment of lumbar spondylolisthesis: the Lumbar Interbody Fusion Trial (LIFT).

BACKGROUND: With a steep increase in the number of instrumented spinal fusion procedures, there is a need for comparative data to develop evidence based treatment recommendations. Currently, the available data on cost and clinical effectiveness of the two most frequently performed surgeries for lumbar spondylolisthesis, transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF), are not sufficient. Therefore, current guidelines do not advise which is the most appropriate surgical treatment strategy for these patients. Non-randomized studies comparing TLIF and PLIF moreover suggest that TLIF is associated with fewer complications, less blood loss, shorter surgical time and hospital duration. TLIF may therefore be more cost-effective. The results of this study will provide knowledge on short- and long-term clinical and economical effects of TLIF and PLIF procedures, which will lead to recommendations for treating patients with lumbar spondylolisthesis. METHODS: Multicenter blinded Randomized Controlled Trial (RCT; blinding for the patient and statistician, not for the clinician and researcher). A total of 144 patients over 18 years old with symptomatic single level lumbar degenerative, isthmic or iatrogenic spondylolisthesis whom are candidates for LIF (lumbar interbody fusion) surgery through a posterior approach will be randomly allocated to TLIF or PLIF. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary clinical outcome measures are: change in disability measured with Oswestry Disability Index (ODI) and change in quality adjusted life years (QALY) measured with EQ-5D-5L. Secondary clinical outcome measures are: Short Form (36) Health Survey (SF-36), VAS back pain, VAS leg pain, Hospital Anxiety Depression Scale (HADS), complications, productivity related costs (iPCQ) and medical costs (iMCQ). Measurements will be carried out at five fixed time points (pre-operatively and at 3, 6, 12 and 24 months). DISCUSSION: It is hypothesized that TLIF, compared to PLIF, has similar clinical outcome or is possibly better in reducing disability. Moreover, direct medical costs are expected to be lower due to less surgical morbidity, shorter hospital stay and shorter surgical time. Indirect costs are assumed to be lower for TLIF as well, because we suspect less working days are lost. Currently, prospective data comparing clinical and cost-effectiveness of both techniques are not available. Therefore, in clinical practice both techniques are used and the choice for technique is greatly based on surgeon's preference. The demand for spinal fusion surgery has risen steeply over the last 10 years and is expected to increase even further in the near future. As a result, the burden on society (and the working population) will increase. In case our hypothesis is confirmed, treatment guidelines will be adapted, and TLIF will be recommended as first choice surgical treatment of lumbar spondylolisthesis. Ultimately this will lead to reduction of (direct and indirect) costs and better clinical outcome for spondylolisthesis patients eligible for instrumented spinal surgery. TRIAL REGISTRATION NUMBER: Netherlands Trial Registry, number 5722 (registration date March 30, 2016).

Cost-Utility Analysis of Instrumented Fusion Versus Decompression Alone for Grade I L4-L5 Spondylolisthesis at 1-Year Follow-up: A Pilot Study.

STUDY DESIGN: Retrospective 1-year cost-utility analysis. OBJECTIVE: To determine the cost-effectiveness of decompression with and without instrumented fusion for patients with grade I degenerative L4-L5 spondylolisthesis at 1-year follow-up. SUMMARY OF BACKGROUND DATA: Despite its benefits to health outcomes, lumbar fusion is associated with substantial costs. This study analyzed the cost-effectiveness of instrumented fusion for grade I L4-L5 spondylolisthesis at 1-year follow-up. MATERIALS AND METHODS: Four cohorts of 25 patients with grade I L4-L5 degenerative spondylolisthesis were analyzed: cohort 1 (decompression), cohort 2 (decompression with instrumented posterolateral fusion (PLF), cohort 3 (decompression with instrumented posterior lumbar interbody fusion/transforaminal lumbar interbody fusion), and cohort 4 (decompression with instrumented PLF and posterior lumbar interbody fusion/transforaminal lumbar interbody fusion). One-year postoperative health outcomes were assessed based on Visual Analogue Scale, Pain Disability Questionnaire, and EuroQol 5 Dimensions questionnaires. Direct medical costs were estimated using Medicare national payment amounts and indirect costs were based on patient missed work days. Postoperative 1-year cost/utility ratios and incremental cost-effectiveness ratios (ICERs) were calculated. Cost-effectiveness was assessed using a threshold of $100,000/QALY gained. RESULTS: Compared with preoperative health states, EuroQol 5 Dimensions QALY scores improved for all cohorts (P<0.01). The 1-year cost-utility ratio for cohort 1 was significantly lower ($56,610/QALY gained; P<0.01) than that for cohorts 2 ($116,991/QALY gained), 3 ($109,740/QALY gained), and 4 ($107,546/QALY gained). The 1-year ICERs relative to cohort 1 were: cohort 2 (dominated), cohort 3 ($1,060,549/QALY gained), and cohort 4 ($830,047/QALY gained). CONCLUSIONS: Decompression without fusion is cost-effective for patients with grade I L4-L5 spondylolisthesis. Decompression with fusion is not cost effective in a 1-year timeframe for these patients based on the threshold. Accordingly, although fusion is beneficial for improving health outcomes in patients with spondylolisthesis, it is not cost-effective when analyzing a 1-year timeframe based on the threshold. The durability of these results must be analyzed with longer term cost-utility analysis studies.

Posterolateral Lumbar Arthrodesis With and Without Interbody Arthrodesis for L4-L5 Degenerative Spondylolisthesis: A Comparative Value Analysis.

STUDY DESIGN: Independent retrospective review of prospectively collected data, comparative cohort study. OBJECTIVE: The objective of this study was to compare the clinical, radiographical, and cost/value of the addition of an interbody arthrodesis (IBA) to a posterolateral arthrodesis (PLA) in the surgical treatment of L4-L5 degenerative spondylolisthesis (DS). The authors hypothesized that the addition of IBA to PLA would produce added value while incurring minimal additional costs. SUMMARY OF BACKGROUND DATA: Many lumbar surgical advances have been made during the past several decades, yet there is a paucity of strong evidence-based validation, let alone comparative value analyses. The addition of an IBA to a PLA has become increasingly popular during the past 2 decades, yet the potential added value for the patient has not been carefully defined. METHODS: Patients undergoing single-level arthrodesis for L4-L5 DS performed at our institution from 2004 to 2012 were identified. Exclusion criteria included multilevel arthrodesis, spinal stenosis requiring decompression at or above L2-L3, previous L4-L5 spinal fusion, spondylolisthesis of greater than 33% of the vertebral body, and use of minimally invasive surgery. Radiographical fusion status, epidemiological, surgical, and functional outcomes, and cost/value data were recorded or calculated. RESULTS: A total of 179 patients with follow-up meeting inclusion criteria were identified: 68 with PLA alone and 111 with PLA + IBA. No statistical differences were noted in Oswestry Disability Index, 36-item Short-Form Health Survey scores, fusion rates, or cost/value at 6 months and at more than 3 years despite the PLA cohort being significantly older with more medical comorbidities. When length of stay was normalized across cohorts, the addition of an IBA increased hospital costs ranging from $577 to $5276, but this did not reach statistical significance. CONCLUSION: This single-center review of open surgical treatment of L4-L5 DS demonstrated that the addition of IBA to PLA added cost while producing equivalent results in fusion rates, Oswestry Disability Index, and 36-item Short-Form Health Survey scores when compared with PLA alone. LEVEL OF EVIDENCE: 3.

Cost-effectiveness of surgical treatment for degenerative spondylolisthesis and spinal stenosis.

STUDY DESIGN: Systematic review. OBJECTIVE: To identify cost-effective treatment strategies for lumbar spine degenerative diseases. SUMMARY OF BACKGROUND DATA: There is a paucity of literature assisting physicians and society regarding the cost-efficiency of management of lumbar spine conditions. Limited articles on selective operative and nonoperative therapies have been published for a variety of lumbar conditions. METHODS: A systematic search of PubMed, EMBASE, the Cochrane Collaboration data base, University of York, Centre for Reviews and Dissemination (National Health Services Economic Evaluation Database and health technology assessment), and the Tufts CEA Registry was conducted through December 16, 2013. Three specific questions were addressed for adult patients: (1) What is the evidence that surgery is cost-effective compared with nonsurgical management for lumbar degenerative spondylolisthesis or stenosis? (2) What is the evidence that fusion is cost-effective compared with no fusion for degenerative spondylolisthesis or stenosis? and (3) What is the evidence that instrumentation is cost-effective compared with none for degenerative spondylolisthesis? The Quality of Health Economic Studies instrument was used to provide an initial basis for critical appraisal of included economic studies. Articles were further refined with individual review based on inclusion/exclusion criteria. RESULTS: Initial search resulted in 122 potentially relevant citations, 115 of which were excluded at title and abstract levels and 3 at full-text reviews, leaving 5 for analysis. No non-English language text met inclusion/exclusion criteria. All studies illustrated a clinical benefit of surgical treatment as measured by quality-adjusted life year (0.11-8.05). Surgical treatments had a greater financial cost than nonoperative care ($5883-$26,035). Incremental cost-effectiveness ratio calculations noted operative treatment over nonoperative treatment for spondylolisthesis ($59,487-$115,600) per quality-adjusted life year. However, cost for patients without spondylolisthesis varied greatly from nonoperative treat dominating to $77,600 per quality-adjusted life year favoring surgery. Because the articles had heterogeneous methods and patient population, conclusion differed greatly on cost assessment. CONCLUSION: Limited quality data exist on cost-effective treatment of degenerative lumbar spinal conditions, despite more recent interest related to this topic. It is important that future research efforts focus on constructing higher quality trials in this area to help determine the most cost-effective care. LEVEL OF EVIDENCE: 3.

Cost-effectiveness of lumbar discectomy and single-level fusion for spondylolisthesis: experience with the NeuroPoint-SD registry.

OBJECT: There is significant practice variation and uncertainty as to the value of surgical treatments for lumbar spine disorders. The authors' aim was to establish a multicenter registry to assess the efficacy and costs of common lumbar spinal procedures by using prospectively collected outcomes. METHODS: An observational prospective cohort study was completed at 13 academic and community sites. Patients undergoing single-level fusion for spondylolisthesis or single-level lumbar discectomy were included. The 36-Item Short Form Health Survey (SF-36) and Oswestry Disability Index (ODI) data were obtained preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: lumbar disc (125 patients) and lumbar listhesis (35 patients). The quality-adjusted life year (QALY) data were calculated using 6-dimension utility index scores. Direct costs and complication costs were estimated using Medicare reimbursement values from 2011, and indirect costs were estimated using the human capital approach with the 2011 US national wage index. Total costs equaled $14,980 for lumbar discectomy and $43,852 for surgery for lumbar spondylolisthesis. RESULTS: There were 198 patients enrolled over 1 year. The mean age was 46 years (49% female) for lumbar discectomy (n = 148) and 58.1 years (60% female) for lumbar spondylolisthesis (n = 50). Ten patients with disc herniation (6.8%) and 1 with listhesis (2%) required repeat operation at 1 year. The overall 1-year follow-up rate was 88%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, visual analog scale, and SF-36 scores (p = 0.0002), which persisted at the 1-year evaluation (p < 0.0001). By 1 year, more than 80% of patients in each cohort who were working preoperatively had returned to work. Lumbar discectomy was associated with a gain of 0.225 QALYs over the 1-year study period ($66,578/QALY gained). Lumbar spinal fusion for Grade I listhesis was associated with a gain of 0.195 QALYs over the 1-year study period ($224,420/QALY gained). CONCLUSIONS: This national spine registry demonstrated successful collection of high-quality outcomes data for spinal procedures in actual practice. These data are useful for demonstrating return to work and cost-effectiveness following surgical treatment of single-level lumbar disc herniation or spondylolisthesis. One-year cost per QALY was obtained, and this cost per QALY is expected to improve further by 2 years. This work sets the stage for real-world analysis of the value of health interventions.

Perioperative outcomes, complications, and costs associated with lumbar spinal fusion in older patients with spinal stenosis and spondylolisthesis.

OBJECT: The purpose of this study was to quantify the perioperative outcomes, complications, and costs associated with posterolateral spinal fusion (PSF) among Medicare enrollees with lumbar spinal stenosis (LSS) and/or spondylolisthesis by using a national Medicare claims database. METHODS: A 5% systematic sample of Medicare claims data (2005-2009) was used to identify outcomes in patients who had undergone PSF for a diagnosis of LSS and/or spondylolisthesis. Patients eligible for study inclusion also required a minimum of 2 years of follow-up and a claim history of at least 12 months prior to surgery. RESULTS: A final cohort of 1672 patients was eligible for analysis. Approximately half (50.7%) had LSS only, 10.2% had spondylolisthesis only, and 39.1% had both LSS and spondylolisthesis. The average age was 71.4 years, and the average length of stay was 4.6 days. At 3 months and 1 and 2 years postoperatively, the incidence of spine reoperation was 10.9%, 13.3%, and 16.9%, respectively, whereas readmissions for complications occurred in 11.1%, 17.5%, and 24.9% of cases, respectively. At 2 years postoperatively, 36.2% of patients had either undergone spine reoperation and/or received an epidural injection. The average Medicare payment was $36,230 ± $17,020, $46,840 ± $31,350, and $61,610 ± $46,580 at 3 months, 1 year, and 2 years after surgery, respectively. CONCLUSIONS: The data showed that 1 in 6 elderly patients treated with PSF for LSS or spondylolisthesis underwent reoperation on the spine within 2 years of surgery, and nearly 1 in 4 patients was readmitted for a surgery-related complication. These data highlight several potential areas in which improvements may be made in the effective delivery and cost of surgical care for patients with spinal stenosis and spondylolisthesis.

Two-year comprehensive medical management of degenerative lumbar spine disease (lumbar spondylolisthesis, stenosis, or disc herniation): a value analysis of cost, pain, disability, and quality of life: clinical article.

OBJECT: Current health care reform calls for a reduction of procedures and treatments that are less effective, more costly, and of little value (high cost/low quality). The authors assessed the 2-year cost and effectiveness of comprehensive medical management for lumbar spondylolisthesis, stenosis, and herniation by utilizing a prospective single-center multidisciplinary spine center registry in a real-world practice setting. METHODS: Analysis was performed on a prospective longitudinal quality of life spine registry. Patients with lumbar spondylolisthesis (n = 50), stenosis (n = 50), and disc herniation (n = 50) who had symptoms persisting after 6 weeks of medical management and who were eligible for surgical treatment were entered into a prospective registry after deciding on nonsurgical treatment. In all cases, comprehensive medical management included spinal steroid injections, physical therapy, muscle relaxants, antiinflammatory medication, and narcotic oral agents. Two-year patient-reported outcomes, back-related medical resource utilization, and occupational work-day losses were prospectively collected and used to calculate Medicare fee-based direct and indirect costs from the payer and societal perspectives. The maximum health gain associated with medical management was defined as the improvement in pain, disability, and quality of life experienced after 2 years of medical treatment or at the time a patient decided to cross over to surgery. RESULTS: The maximum health gain in back pain, leg pain, disability, quality of life, depression, and general health state did not achieve statistical significance by 2 years of medical management, except for pain and disability in patients with disc herniation and back pain in patients with lumbar stenosis. Eighteen patients (36%) with spondylolisthesis, 11 (22%) with stenosis, and 17 (34%) with disc herniation eventually required surgical management due to lack of improvement. The 2-year improvement did not achieve a minimum clinically important difference in any outcome measure. The mean 2-year total cost (direct plus indirect) of medical management was $6606 for spondylolisthesis, $7747 for stenosis, and $7097 for herniation. CONCLUSIONS: In an institution-wide, prospective, longitudinal quality of life registry that measures cost and effectiveness of all spine care provided, comprehensive medical management did not result in sustained improvement in pain, disability, or quality of life for patients with surgically eligible degenerative lumbar spondylolisthesis, stenosis, or disc herniation. From both the societal and payer perspective, continued medical management of patients with these lumbar pathologies in whom 6 weeks of conservative therapy failed was of minimal value given its lack of health utility and effectiveness and its health care costs. The findings from this real-world practice setting may more accurately reflect the true value and effectiveness of nonoperative care in surgically eligible patient populations.

Surgical management of lumbar degenerative spondylolisthesis.

Lumbar degenerative spondylolisthesis (DS) is a common cause of low back pain, radiculopathy, and/or neurogenic claudication. Treatment begins with a trial of nonsurgical methods, including physical therapy, NSAIDs, and epidural corticosteroid injections. Surgical treatment with decompression and fusion is recommended for patients who do not respond to this initial regimen. Although much has been published in the past two decades on the surgical management of DS, the optimal method remains controversial. Interbody fusion may improve arthrodesis rates and can be performed via numerous surgical approaches. Minimally invasive techniques continue to be developed. Particular attention to surgical management of DS in the elderly is warranted given the increasing numbers of elderly persons. Healthcare utilization in the future must take into account evidence-based medicine that establishes clinically effective practices while simultaneously being cost effective.

A perioperative cost analysis comparing single-level minimally invasive and open transforaminal lumbar interbody fusion.

BACKGROUND CONTEXT: Emerging literature suggests superior clinical short- and long-term outcomes of MIS (minimally invasive surgery) TLIFs (transforaminal lumbar interbody fusion) versus open fusions. Few studies to date have analyzed the cost differences between the two techniques and their relationship to acute clinical outcomes. PURPOSE: The purpose of the study was to determine the differences in hospitalization costs and payments for patients treated with primary single-level MIS versus open TLIF. The impact of clinical outcomes and their contribution to financial differences was explored as well. STUDY DESIGN/SETTING: This study was a nonrandomized, nonblinded prospective review. PATIENT SAMPLE: Sixty-six consecutive patients undergoing a single-level TLIF (open/MIS) were analyzed (33 open, 33 MIS). Patients in either cohort (MIS/open) were matched based on race, sex, age, smoking status, medical comorbidities (Charlson Comorbidity index), payer, and diagnosis. Every patient in the study had a diagnosis of either degenerative disc disease or spondylolisthesis and stenosis. OUTCOME MEASURES: Operative time (minutes), length of stay (LOS, days), estimated blood loss (EBL, mL), anesthesia time (minutes), Visual Analog Scale (VAS) scores, and hospital cost/payment amount were assessed. METHODS: The MIS and open TLIF groups were compared based on clinical outcomes measures and hospital cost/payment data using SPSS version 20.0 for statistical analysis. The two groups were compared using bivariate chi-squared analysis. Mann-Whitney tests were used for non-normal distributed data. Effect size estimate was calculated with the Cohen d statistic and the r statistic with a 95% confidence interval. RESULTS: Average surgical time was shorter for the MIS than the open TLIF group (115.8 minutes vs. 186.0 minutes respectively; p=.001). Length of stay was also reduced for the MIS versus the open group (2.3 days vs. 2.9 days, respectively; p=.018). Average anesthesia time and EBL were also lower in the MIS group (p<.001). VAS scores decreased for both groups, although these scores were significantly lower for the MIS group (p<.001). Financial analysis demonstrated lower total hospital direct costs (blood, imaging, implant, laboratory, pharmacy, physical therapy/occupational therapy/speech, room and board) in the MIS versus the open group ($19,512 vs. $23,550, p<.001). Implant costs were similar (p=.686) in both groups, although these accounted for about two-thirds of the hospital direct costs in the MIS cohort ($13,764) and half of these costs ($13,778) in the open group. Hospital payments were $6,248 higher for open TLIF patients compared with the MIS group (p=.267). CONCLUSIONS: MIS TLIF technique demonstrated significant reductions of operative time, LOS, anesthesia time, VAS scores, and EBL compared with the open technique. This reduction in perioperative parameters translated into lower total hospital costs over a 60-day perioperative period. Although hospital reimbursements appear higher in the open group over the MIS group, shorter surgical times and LOS days in the MIS technique provide opportunities for hospitals to reduce utilization of resources and to increase surgical case volume.

Economic study: a cost-effectiveness analysis of an intraoperative compared with a preoperative image-guided system in lumbar pedicle screw fixation in patients with degenerative spondylolisthesis.

BACKGROUND CONTEXT: In spinal surgery, newly developed technology seems to play a key role, especially with the use of computer-assisted image-guided navigation, giving excellent results. However, these tools are expensive and may not be affordable for many facilities. PURPOSE: To compare the cost-effectiveness of preoperative versus intraoperative CT (computed tomography) guidance in spinal surgery. STUDY DESIGN: A retrospective economic study. METHODS: A cost-effectiveness study was performed analyzing the overall costs of a population of patients operated on for lumbar degenerative spondylolisthesis using an image-guided system (IGS) based on a CT scan. The population was divided into two groups according to the type of CT data set acquisition adopted: Group I (IGS based on a preoperative spiral CT scan), Group II (IGS based on an intraoperative CT scan-O-Arm system). The costs associated with each procedure were assessed through a process analysis, where clinical procedures were broken down into single phases and the related costs from each phase were evaluated. No benefits in any form have been or will be received from commercial parties directly or indirectly related to the subject of this article. RESULTS: Four hundred ninety-nine patients met the criteria for this study. In total, 2,542 screws were inserted with IGS. Baseline data were similar for the two groups, as were hospitalization and complications. The surgical time was 119±43 minutes in Group I and 92±31 minutes in Group II. The full cost of the two procedures was analyzed: the mean cost, using the O-Arm system (Group II), was found to be €255.83 (3.80%) less than the cost of Group I. Moreover, the O-Arm system was also used in other surgical procedures as an intraoperative control, thus reducing the final costs of radiologic examinations (a reduction of around 550 CT scans/year). CONCLUSIONS: In conclusion, the authors of the study are of the opinion that the surgical procedure of pedicle screw fixation, using a CT-based computer-guidance system with support of the O-Arm system, allows a shortening of procedure time that might improve the clinical result. However, the present study failed to determine a clear cost-effectiveness with respect to other CT-based IGS.