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Background: The concept of the S2-alar-iliac (S2AI) screw was developed approximately one decade ago and has rapidly become an important component of spinal arthrodesis. Two challenges to placing S2AI screws are gaining an intuition for free-hand screw placement trajectory and acquisition of the appropriate radiograph to both guide screw placement and diagnose misplacement., Objective: To present the design and manufacture of an S2AI screw placement simulator and teaching module that addresses both challenges., Methods: This simulator involves using a 3D printer to create a life-sized pelvis. Participants first used this print to practice placing free-hand S2AI screws. Then participants used another print to practice taking radiographs showing the posterior superior iliac spine-anterior superior iliac spine corridor (teardrop) view., Results: The accuracy of screw placement increased from 17 to 80% on the left side and 7 to 100% on the right side. The number of radiographs taken by each participant to obtain the teardrop view decreased after practice with the simulator compared to baseline., Conclusion: Practice with the S2AI simulator led to an improved intuition of an appropriate free-hand S2AI screw trajectory and a decrease in the number of radiographs needed for obtaining the correct diagnostic view., (Copyright © 2019 by the Congress of Neurological Surgeons.)

Background: Considerable variability exists in the cost of surgery following spine surgery for common degenerative spine diseases. This variation in the cost of surgery can affect the payment bundling during the postoperative 90 d., Objective: To determine the drivers of variability in total 90-d cost for laminectomy and fusion surgery., Methods: A total of 752 patients who underwent elective laminectomy and fusion for degenerative lumbar conditions and were enrolled into a prospective longitudinal registry were included in the study. Total cost during the 90-d global period was derived as sum of cost of surgery, cost associated with postdischarge utilization. Multivariable regression models were built for total 90-d cost., Results: The mean 90-d direct cost was $29 295 (range, $28 612-$29 973). Based on our regression tree analysis, the following variables were found to drive the 90-d cost: age, BMI, gender, diagnosis, postop imaging, number of operated levels, ASA grade, hypertension, arthritis, preop and postop opioid use, length of hospital stay, duration of surgery, 90-d readmission, outpatient physical/occupational therapy, inpatient rehab, postop healthcare visits, postop nonopioid pain medication use nonsteroidal antiinflammatory drug (NSAIDs), and muscle relaxant use. The R2 for tree model was 0.64., Conclusion: Utilizing prospectively collected data, we demonstrate that considerable variation exists in total 90-d cost, nearly 70% of which can be explained by those factors included in our modeling. Risk-adjusted payment schemes can be crafted utilizing the significant drivers presented here. Focused interventions to target some of the modifiable factors have potential to reduce cost and increase the value of care., (Copyright © 2018 by the Congress of Neurological Surgeons.)

Background: Value-based episode of care reimbursement models is being investigated to curb unsustainable health care costs. Any variation in the cost of index spine surgery can affect the payment bundling during the 90-d global period., Objective: To determine the drivers of variability in cost for patients undergoing elective anterior cervical discectomy and fusion (ACDF) for degenerative cervical spine disease., Methods: Four hundred forty-five patients undergoing elective ACDF for cervical spine degenerative diagnoses were included in the study. The direct 90-d cost was derived as sum of cost of surgery, cost associated with postdischarge utilization. Multiple variable linear regression models were built for total 90-d cost., Results: The mean 90-d direct cost was $17685 ± $5731. In a multiple variable linear regression model, the length of surgery, number of levels involved, length of hospital stay, preoperative history of anticoagulation medication, health-care resource utilization including number of imaging, any complications and readmission encounter were the significant contributor to the 90-d cost. The model performance as measured by R2 was 0.616., Conclusion: There was considerable variation in total 90-d cost for elective ACDF surgery. Our model can explain about 62% of these variations in 90-d cost. The episode of care reimbursement models needs to take into account these variations and be inclusive of the factors that drive the variation in cost to develop a sustainable payment model. The generalized applicability should take in to account the differences in patient population, surgeons' and institution-specific differences.

Background Context: Over the last decade, clinical investigators and biomedical industry groups have used significant resources to develop advanced technologies that enable less invasive spine fusions. These minimally invasive surgery (MIS) technologies often require increased expenditures by hospitals and payers. Although several small single center studies have suggested MIS technologies decrease surgical morbidity and reduce hospital stay, evidence documenting benefit from a patient perspective remains limited. Furthermore, MIS outcomes have yet to be evaluated from the perspective of multiple practice types representing the broad spectrum of US spine surgery., Purpose: This study aimed to examine a population of patients who underwent one- or two-level interbody lumbar fusion diagnosed with lumbar stenosis or Grade 1 spondylolisthesis in an observational, prospective national registry for the purposes of determining how MIS and traditional open technologies affect postsurgical and patient-reported outcomes (PROs)., Study Design/setting: This study used observational analysis of prospectively collected data., Patient Sample: The sample consisted of cases from the National Neurosurgery Quality and Outcomes Database (N 2 QOD)., Outcome Measures: Numeric rating scale for back and leg pain, Oswestry Disability Index, EuroQol-5D, return to work, and perioperative morbidity were the outcome measures., Methods: The N 2 QOD is a prospective PROs registry enrolling patients undergoing elective spine surgery from 60 hospitals in 27 US states via representative sampling. We analyzed the N 2 QOD aggregate dataset (2010-2014) to identify one- and two-level lumbar interbody fusion procedures performed for lumbar stenosis or Grade 1 spondylolisthesis with 12 months' follow-up where surgical instrumentation and implant types were clearly identified. Perioperative and 1-year outcomes were compared between cases performed with MIS enabling technologies versus traditional open technologies before and after propensity matching., Results: There were 467 (24%) patients who underwent elective interbody lumbar fusion using MIS enabling technologies whereas 1,480 (76%) underwent the procedure using traditional open technologies. The MIS patients were slightly healthier (American Society of Anesthesiologists grade), had private insurance more frequently, and underwent two-level fusion less frequently. Unmatched, the MIS cohort was associated with reduced blood loss, a 0.7-day reduction in mean length of hospital stay, and 5% reduced need for post-discharge inpatient rehabilitation, but equivalent 90-day safety measures. After propensity matching, the MIS cohort remained associated with reduced blood loss and a shorter length of stay for one-level fusion (p<.05) but had equivalent length of stay for two-level fusion. Outcomes in all other 90-day safety measures were similar. In both unadjusted and propensity-matched comparison, MIS versus open technologies were associated with equivalent return to work, patient-reported pain, physical disability, and quality of life at 3 and 12 months' follow-up., Conclusions: In a representative sampling registry of elective interbody lumbar spine fusion procedures spanning 27 US states, nearly a quarter of procedures performed from 2010 to 2014 used minimally invasive enabling technologies. Regardless of approach, interbody lumbar fusion was associated with significant and sustained improvements in all measured health domains. When used in everyday care by a wide spectrum of spine surgeons in non-research settings, the use of MIS technologies was associated with reduced intraoperative blood loss but only a half-day reduction in mean length of hospital stay for one-level fusions. Minimally invasive surgery was not associated with any improved perioperative safety measures or 12-month outcomes. Although MIS enabling technologies may increase some in-hospital care efficiencies, MIS clinical outcomes are similar to open surgery for patients undergoing one- and two-level interbody lumbar fusions., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Purpose: With growing older population and increasing rates of cervical spinal surgery, it is vital to understand the value of cervical surgery in this population. We set forth to determine the cost utility following anterior cervical decompression and fusion (ACDF) for degenerative disease in older patients., Methods: Patients undergoing ACDF for degenerative diseases were enrolled into prospective longitudinal registry. Patient-reported outcomes (PROs) were recorded at baseline, 1-year, and 2-year postoperatively. Two-year medical resource utilization, missed work, and health-state values [quality-adjusted life years (QALYs)] were assessed to compute cost per QALY gained. Patients were dichotomized based on age: <65 years (younger) and ≥65 years (older) to compare the cost utility in these age groups., Results: Total 218 (87%) younger patients and 33 (13%) older patients who underwent ACDF were analyzed. Both the groups demonstrated a significant improvement in PROs 2-year following surgery. The older patients had a lower mean cumulative gain in QALYs compared to younger patients at 1 year (0.141 vs. 0.28, P = 0.05) and 2 years (0.211 vs. 0.424, P = 0.04). There was no significant difference in the mean total 2-year cost between older [$21,041 (95% CI $18,466-$23,616)] and younger [$22,669 (95% CI $$21,259-$24,079)] patients (P = 0.27). Two-year cost per QALY gained in older vs. younger patients was ($99,720/QALYs gained vs. ($53,464/QALYs gained, P = 0.68)., Conclusion: ACDF surgery provided a significant gain in health-state utility in older patients with degenerative cervical pathology, with a mean cumulative 2-year cost per QALY gained of $99,720/QALY. While older patients have a slightly higher cost utility compared to their younger counterparts, surgery in the older cohort does provide a significant improvement in pain, disability, and quality-of-life outcomes.

Background: Obese patients have greater comorbidities along with higher risk of complications and greater costs after spine surgery, which may result in increased cost and lower quality of life compared with their non-obese counterparts., Purpose: The aim of the present study was to determine cost-utility following anterior cervical discectomy and fusion (ACDF) in obese patients., Study Design: This study analyzed prospectively collected data., Patient Sample: Patients undergoing elective ACDF for degenerative cervical pathology at a single academic institution were included in the study., Outcome Measures: Cost and quality-adjusted life years (QALYs) were the outcome measures., Methods: One- and two-year medical resource utilization, missed work, and health state values (QALYs) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Total cost (direct+indirect) was used to compute cost per QALY gained. Patients were defined as obese for body mass index (BMI) ≥35 based on the WHO definition of class II obesity. A subgroup analysis was conducted in morbidly obese patients (BMI≥40)., Results: There were significant improvements in pain (neck pain or arm pain), disability (Neck Disability Index), and quality of life (EuroQol-5D and Short Form-12) at 2 years after surgery (p<.001). There was no significant difference in post-discharge health-care resource utilization, direct cost, indirect cost, and total cost between obese and non-obese patients at postoperative 1-year and 2-year follow-up. Mean 2-year direct cost for obese patients was $19,225±$8,065 and $17,635±$6,413 for non-obese patients (p=.14). There was no significant difference in the mean total 2-year cost between obese ($23,144±$9,216) and non-obese ($22,183±$10,564) patients (p=.48). Obese patients had a lower mean cumulative gain in QALYs versus non-obese patients at 2-years (0.34 vs. 0.42, p=.32). Two-year cost-utility in obese ($68,070/QALY) versus non-obese patients ($52,816/QALY) was not significantly different (p=.11). Morbidly obese patients had lower QALYs gained (0.17) and higher cost per QALYs gained ($138,094/QALY) at 2 years., Conclusions: Anterior cervical discectomy and fusion provided a significant gain in health state utility in obese patients, with a mean 2-year cost-utility of $68,070 per QALYs gained, which can be considered moderately cost-effective. Morbidly obese patients had lower cost-effectiveness; however, surgery does provide a significant improvement in outcomes. Obesity, and specifically morbid obesity, should to be taken into consideration as physician and hospital reimbursements move toward a bundled model., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background Context: Pelvic fixation improves fusion and stability for thoracolumbar constructs that extend across the L5-S1 junction. No patient-reported outcomes have been published to evaluate patients' functional outcomes following these procedures compared with pelvis-sparing procedures., Purpose: The goal of this study is to identify the effect of pelvic fixation on both objective and patient-reported outcomes., Study Design/setting: This was a retrospective, matched cohort study., Patient Sample: The sample comprised adult patients undergoing spine surgery at our institution who had complete 1-year postoperative follow-up., Outcome Measures: Patient-reported outcome instruments (Oswestry Disability Index [ODI], Short-Form 12-item survey, and EuroQol-5D) and objective measures (length of hospital stay, discharge disposition, postoperative complications, and readmission rates) were considered., Methods: We identified patients in our outcomes registry undergoing instrumented spinal fusion involving the pelvis between October 2010 and May 2014 who had 1-year follow-up data. Nearest-neighbor 1:1 matched controls were identified using propensity scoring from the cohort of patients undergoing any spinal procedure which extended caudally to the lumbar spine or sacrum. Objective and patient-reported outcomes were compared between cases and controls., Results: There were 44 patients who underwent spinal procedures involving the pelvis and had 1-year follow-up data. An equal number of controls were identified and had similar baseline demographic and clinical characteristics. No significant differences were found among operative variables or objective complication rates. Patients undergoing pelvic fixation had moderately greater improvement at 3 months as measured by ODI, but this difference was not present at 1 year. Other patient-reported outcome measures were equivocal between groups., Conclusions: This matched cohort study demonstrates that inclusion of the pelvis in spinal hardware constructs is not associated with increased complications and may slightly improve patient disability at 1 year. Given that pelvic fixation may reduce L5-S1 breakdown and improve biomechanics, surgeons should more readily include the pelvis in instrumented fusion procedures., (Copyright © 2016 Elsevier Inc. All rights reserved.)

OBJECT In an era of escalating health care cost and universal pressure of improving efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and is rapidly increasing with an expanding aging population. While ASCs offer cost advantages for ACDF, there is a scarcity of evidence that ASCs allow for equivalent quality and thus superior health care value. Therefore, the authors analyzed a nationwide, prospective quality improvement registry (National Surgical Quality Improvement Program [NSQIP]) to compare the quality of ACDF surgery performed in the outpatient ASC versus the inpatient hospital setting. METHODS Patients undergoing ACDF (2005-2011) were identified from the NSQIP database based on the primary Current Procedural Terminology codes. Patients were divided into 2 cohorts (outpatient vs inpatient) based on the acute care setting documented in the NSQIP database. All 30-day surgical morbidity and mortality rates were compared between the 2 groups. Propensity score matching and multivariate logistic regression analysis were used to adjust for confounding factors and to identify the independent association of outpatient ACDF with perioperative outcomes and morbidity. RESULTS A total of 7288 ACDF cases were identified (inpatient = 6120, outpatient = 1168). Unadjusted rates of major morbidity (0.94% vs 4.5%, p < 0.001) and return to the operating room (OR) within 30 days (0.3% vs 2.0%, p < 0.001) were significantly lower in outpatient versus inpatient ACDF. After propensity matching 1442 cases (inpatient = 650, outpatient = 792) based on baseline 32 covariates, rates of major morbidity (1.4% vs 3.1%, p = 0.03), and return to the OR (0.34% vs 1.4%, p = 0.04) remained significantly lower after outpatient ACDF. Adjusted comparison using multivariate logistic regression demonstrated that ACDF performed in the outpatient setting had 58% lower odds of having a major morbidity and 80% lower odds of return to the OR within 30 days. CONCLUSIONS An analysis of a nationwide, prospective quality improvement registry representing more than 250 hospitals demonstrates that 1- to 2-level ACDF can be safely performed in the outpatient ambulatory surgery setting in patients who are appropriate candidates. In an effort to decrease cost of care, surgeons can safely consider performing ACDF in an ASC environment.

Background: Value-based purchasing is rapidly being implemented to rein in the unsustainably rising costs of the US healthcare system. With a growing elderly population, it is vital to understand the value of spinal surgery in this group of individuals., Objective: To compare the cost-effectiveness of lumbar decompression with and without fusion for degenerative spine disease in elderly vs nonelderly patients., Methods: A total of 221 patients undergoing elective primary surgery for degenerative lumbar pathology who were enrolled in a prospective longitudinal registry were analyzed. Patient-reported outcomes of Oswestry Disability Index, numeric rating scale for back and leg pain, and quality-of-life scores (EuroQol-5D) were recorded. Two-year back-related medical resource use, missed work, and health-state values (quality-adjusted life-years [QALYs]) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost). Patient and caregiver workday losses were multiplied by gross-of-tax wage rate (indirect cost). Patients were divided into age groups <70 and ≥70 years., Results: Mean cumulative 2-year QALYs gained were statistically similar between younger and older patients for both decompression alone (0.67 ± 0.65 vs 0.56 ± 0.65; P = .47) and decompression with fusion (0.56 ± 0.55 vs 0.59 ± 0.55; P = .26). Mean 2-year cost per QALY gained between younger and older patients was similar for both decompression alone ($24,365 vs $31,750 per QALY; P = .11) and decompression with fusion ($64,228 vs $60,183 per QALY; P = .09)., Conclusion: Surgical treatment provided significant improvements in pain, disability, and quality of life for elderly patients with degenerative lumbar disease. Observed costs per QALY gained for lumbar decompression with and without fusion were similar for younger and older patients, demonstrating that lumbar spine surgery in the elderly is an equally cost-effective and valuable intervention.

Study Design: Mixed retrospective-prospective cohort study., Objective: To characterize practice patterns for the use of Cell Saver at our institution, investigate its cost-effectiveness, and propose a new tool for patient selection., Summary of Background Data: Blood loss is an exceedingly common complication of spine surgery, and Cell Saver intraoperative cell salvage has been used to decrease reliance on allogeneic blood transfusions for blood volume replacement. The cost-effectiveness of Cell Saver has not been established for lumbar spinal surgery, and no universal guidelines exist for clinicians to decide when to utilize this tool. Other authors have proposed cutoffs for anticipated blood loss volumes which indicate that Cell Saver should be used., Methods: Five hundred and eight patients undergoing lumbar laminectomy in 3 or fewer levels were reviewed from our prospective spinal outcomes registry. Cost information for Cell Saver and allogeneic transfusions was collected from our institution's billing and collections department. Logistic regression was used to identify patient characteristics associated with use of Cell Saver. An incremental cost effectiveness ratio was calculated based on transfusion and cost data. A clinical prediction score was derived using logistic regression., Results: Use of Cell Saver correlated with increased age, higher body mass index, diabetes, greater American Society of Anesthesiologists classification, and greater number of previous spine surgeries. Outcomes for patients who did and did not have Cell Saver set up intraoperatively were equivocal. Cell Saver was not cost effective based on current usage patterns, but may become cost effective if used for patients with high expected blood loss. A simple clinical prediction rule is proposed which may aid in selection of patients to have Cell Saver present intraoperatively., Conclusion: Cell Saver is not a cost-effective intervention but may become cost effective if a threshold of expected intraoperative blood loss is used to select patients more judiciously., Level of Evidence: 3.

Background: The ability to understand factors associated with an increased duration of missed work postoperatively could be used to more effectively select patients with the greatest opportunity for a successful outcome. We set out to determine the effect of preoperative depression on postoperative return to work in patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative spondylolisthesis., Methods: Fifty-eight patients undergoing TLIF for symptomatic grade I degenerative lumbar spondylolisthesis were included in this analysis. Patient demographics, clinical presentation, indications for surgery, radiologic studies, and operative variables were assessed for each case. Patient-assessed outcome measures were obtained prospectively at baseline and 2 years postoperatively. To understand the factors associated with prolonged return to work, univariate linear regression analysis and stepwise multivariate Cox proportional hazards model was used., Results: All patient-reported outcomes assessed were significantly improved 2 years after TLIF (P < 0.001). Of the 32 patients working preoperatively, 26 (81%) returned to work postoperatively. Median time to return to work was 56 days (range, 10-150 days). Independent of patient age; preoperative pain, disability, and quality of life; and extent of postoperative improvement, increased preoperative Zung depression score remained associated with prolonged return to work (P = 0.02)., Conclusions: Independent of postoperative improvement in pain, disability, and quality of life, the extent of preoperative depression was an independent predictor of time to return to work in patients undergoing TLIF for spondylolisthesis, suggesting that regardless of how successful TLIF surgery may be at improving a patient's pain, disability, or quality of life, greater depression will delay or prohibit their ability to return to work postoperatively., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Study Design: Single cohort study of patients undergoing revision fusion for lumbar pseudoarthrosis., Objective: To assess the 2-year comprehensive costs of revision arthrodesis for lumbar pseudoarthrosis at our institution and determine the associated cost per quality-adjusted life year (QALY) gained in this patient population., Summary of Background Data: The proportion of lumbar spine operations involving a fusion procedure has increased over the past 2 decades. Similarly, there has been a corresponding increase in the incidence and prevalence of pseudoarthrosis. However, the cost-effectiveness of revision surgery for pseudoarthrosis-associated back pain has yet to be examined., Methods: Forty-seven patients undergoing revision instrumented arthrodesis for pseudoarthrosis-associated back pain were included. Two-year total back-related medical resource utilization, missed work, and health-state values (QALYs, calculated from EuroQuol 5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost) and patient and care-giver work-day losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after revision surgery was assessed., Results: The mean (±SD) duration of time between prior fusion and development of symptomatic pseudoarthrosis was 2.69±3.09 years. None of the patients developed symptomatic pseudoarthrosis after 2 years of revision surgery. A mean cumulative 2-year gain of 0.35 QALYs was reported. The mean (±SD) total 2-year cost of revision fusion was $41,631±$9691 (surgery cost: $23,865±$270; outpatient resource utilization cost: $4885±$2301; indirect cost: $12,879±$8171). Revision instrumented arthrodesis was associated with a mean 2-year cost per QALY gained of $118,945., Conclusions: Revision arthrodesis was associated with improved 2-year quality of life in patients with pseudoarthrosis-related back pain. Nevertheless, in our experience revision surgery was shown to be marginally cost-effective at $118,945 per QALY gained.

Background: Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients., Objective: To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED)., Methods: Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50,000/QALY and < $75,000/QALY. MCID was determined with the health transition item as the anchor., Results: Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42,854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43,560 vs $112,087), visual analog scale for back pain ($41,280 vs $129440), Oswestry Disability Index ($30,954 vs $121,750), and EuroQol 5D ($35800 vs $189412)., Conclusion: MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of < $50,000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry Disability Index, and 0.31 QALYs for EuroQol 5D.

Background Context: Prospective registries have emerged as a feasible way to capture real-world care across large patient populations. However, the proven validity of more robust and cumbersome patient-reported outcomes instruments (PROis) must be balanced with what is feasible to apply in large-scale registry efforts., Purpose: To determine the relative validity and responsiveness of common PROis in accurately determining effectiveness of lumbar fusion for degenerative lumbar spondylolisthesis in registry efforts., Study Design: Prospective cohort study., Patient Sample: Fifty-eight patients undergoing transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar spondylolisthesis, Outcome Measures: Patient-reported outcome measures for pain (numeric rating scale for back and leg pain [NRS-BP, NRS-LP]), disability (Oswestry Disability Index [ODI]), general health (Short Form [SF]-12), quality of life (QOL) (EuroQol five dimensions [EQ-5D]), and depression (Zung depression scale [ZDS]) were assessed., Methods: Fifty-eight patients undergoing primary TLIF for lumbar spondylolisthesis were entered into an institutional registry and prospectively followed for 2 years. Baseline and 2-year patient-reported outcomes were assessed. To assess the validity of PROis to discriminate between effective and noneffective improvements, receiver operating characteristic curves were generated for each outcomes instrument. An area under the curve (AUC) of ≥0.80 was considered an accurate discriminator. The difference between standardized response means (SRMs) in patients reporting meaningful improvement versus not was calculated to determine the relative responsiveness of each instrument., Results: For pain and disability, ODI had AUC=0.94, suggesting it as an accurate discriminator of meaningful improvement. Oswestry Disability Index was most responsive to postoperative improvement (SRM difference: 2.18), followed by NRS-BP and NRS-LP. For general health and QOL, SF-12 physical component score (AUC: 0.90), ZDS (AUC: 0.89), and SF-12 mental component score (AUC: 0.85) were all accurate discriminators of meaningful improvement, however, EQ-5D was most accurate (AUC: 0.97). EuroQol five dimensions was also most responsive (SRM difference: 2.83)., Conclusions: For pain and disability, ODI was the most valid and responsive measure of effectiveness of lumbar fusion. Numeric rating scale-BP and NRS-LP should not be used as substitutes for ODI in measuring effectiveness of care in registry efforts. For health-related QOL, EQ-5D was the most valid and responsive measure of improvement, however, SF-12 and ZDS are valid alternatives with less responsiveness., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Study Design: Single-cohort study of patients undergoing revision neural decompression and fusion for same-level recurrent lumbar stenosis., Objective: To assess the long-term outcomes of revision surgery using validated patient-reported outcomes measures., Summary of Background Data: Recurrent lumbar stenosis may occur after lumbar spine surgery, leading to significant discomfort and radicular pain. Although numerous studies have reported clinical outcomes after primary lumbar surgery, there remains a paucity of data on the outcomes after revision surgery for recurrent same-level stenosis., Methods: Fifty-three patients undergoing revision neural decompression and instrumented fusion for same-level recurrent stenosis-associated back and leg pain were included in this study. Baseline and 2-year visual analog scale for leg pain (LP-VAS), visual analog scale for low back pain (BP-VAS), Oswestry Disability Index (ODI), Zung self-reported depression score (ZDS), time to narcotic independence, time to return to work, health-state utility [EuroQol (EQ-5D)], and physical and mental quality of life [SF-12 physical and mental component scores (PCS and MCS)] were assessed., Results: Mean±SD duration of time between index surgery and revision surgery was 4.00±4.19 years. A significant improvement from baseline was observed in BP-VAS (9.28±1.01 vs. 5.00±2.94, P=0.001), LP-VAS (9.55±0.93 vs. 3.45±2.95, P=0.001), and ODI (36.02±6.01 vs. 21.75±12.08, P=0.001). Mean±SD SF-12 PCS (7.17±11.22, P=0.001), SF-12 MCS (12.57±13.03, P=0.001), ZDS (12.37±16.80, P=0.001), and EQ-5D (0.42±0.34, P=0.001) were also significantly improved. The mean cumulative 2-year gain in health-utility state was 0.84 QALY. Median (interquartile range) duration of postoperative narcotic use was 6 (1.4-12.2) months and time of missed work was 6 (4.0-10.0) months., Conclusions: Our study suggests that revision neural decompression and instrumented fusion for recurrent same-level stenosis provides significant improvement in all patient-assessed outcome metrics and should be offered as a viable treatment option.

Background: Minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) for lumbar spondylolisthesis allows for the surgical treatment of back/leg pain while minimizing tissue injury and accelerating the patient's recovery. Although previous results have shown shorter hospital stays and decreased intraoperative blood loss for MIS versus open TLIF, short- and long-term outcomes have been similar. Therefore, we performed comparative effectiveness and cost-utility analysis for MIS versus open TLIF., Methods: A total of 100 patients (50 MIS, 50 open) undergoing TLIF for lumbar spondylolisthesis were prospectively studied. Back-related medical resource use, missed work, and quality-adjusted life years were assessed. Cost of in-patient care, direct cost (2-year resource use × unit costs based on Medicare national allowable payment amounts), and indirect cost (work-day losses × self-reported gross-of-tax wage rate) were recorded, and the incremental cost-effectiveness ratio was calculated., Results: Length of hospitalization and time to return to work were less for MIS versus open TLIF (P = 0.006 and P = 0.03, respectively). MIS versus open TLIF demonstrated similar improvement in patient-reported outcomes assessed. MIS versus open TLIF was associated with a reduction in mean hospital cost of $1758, indirect cost of $8474, and total 2-year societal cost of $9295 (P = 0.03) but similar 2-year direct health care cost and quality-adjusted life years gained., Conclusions: MIS TLIF resulted in reduced operative blood loss, hospital stay and 2-year cost, and accelerated return to work. Surgical morbidity, hospital readmission, and short- and long-term clinical effectiveness were similar between MIS and open TLIF. MIS TLIF may represent a valuable and cost-saving advancement from a societal and hospital perspective., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: Regardless of the etiology, severe cervical deformities can be extremely debilitating and are a challenge to correct. Often a multi-modality team approach is required to safely and effectively reduce the deformity, provide adequate decompression, and ensure solid fixation and fusion. In cases of iatrogenic cervical deformity necessitating five-level corpectomy and fixation, the feasibility, safety, and durability of this procedure remains unknown., Results: We describe a patient who presented with debilitating pain and inability to eat due to an iatrogenic chin-on-chest cervical kyphotic deformity. The patient underwent a back-front-back staged procedure requiring five-level cervical vertebrectomy, C3-T1 anterior fixation, and occipital to T5 posterior fusion, resulting in successful reduction of cervical kyphosis from 75 to 0 degrees. At 6 months post-operatively, the patient demonstrated marked improvement in neurologic function and reported substantial improvements in neck pain-specific disability (NDI) and quality of life (SF-12 and EQ-5D)., Conclusion: The feasibility and safety of five-level vertebrectomy and reconstruction for chin-on-chest deformity remains poorly described. The current case suggests that thoughtful planning that involves maximizing the patient's health status, judicious use of traction under direct neurological examination, staged circumferential release, and design of a construct that provides anterior and posterior column support with several points of fixation beyond the axis of rotation will attenuate the risk of peri-operative morbidity and potentiate the durability of deformity correction.

Study Design: Retrospective case series., Objective: Evaluate the incidence and clinical significance of vascular encroachment resulting from freehand placement of pedicle screws in the thoracic and lumbosacral spine., Summary of Background Data: Pedicle screws are routinely used to effectively stabilize all 3 columns of the spine but can be technically demanding to place in the setting of variable anatomy. There is a paucity of data regarding iatrogenic major vascular injuries during posterior instrumentation procedures., Methods: We retrospectively reviewed the records of all patients undergoing freehand pedicle screw placement without image guidance in the thoracic or lumbar spine during a 7-year period. The incidence and extent of vascular encroachment by a pedicle screw was determined by review of routine postoperative computed tomographic scans obtained within 24 hours of all surgical procedures. Vascular encroachment was defined as a pedicle screw that was touching or deforming the wall of a major vessel., Results: A total of 964 patients received 6816 freehand-placed pedicle screws in the thoracolumbar spine. Fifteen (0.22%) screws that encroached a major vascular structure were identified. Ten (0.29%) thoracic pedicle screws encroached on the aorta, 4 (0.14%) lumbar screws on the common iliac vein, and 1 S1 screw (0.19%) on the internal iliac vein. In consultation with vascular surgery, it was determined whether revision surgery and the technique/approach for the revision procedure should be recommended. Two (0.21%) patients required revision surgery to remove the encroaching pedicle screw (T5 and T8) due to concern for vascular injury. Both patients were asymptomatic and recovered without further complications after revision surgery., Conclusion: Vascular encroachment of major vessels occurs rarely in the setting of freehand pedicle screw placement in the thoracolumbar spine. Although rare, delayed vascular injury from errant pedicle screw placement has been reported in the literature. The aorta seems to be the vessel at the highest risk of injury. Routine intraoperative or postoperative computed tomographic scanning allows for early identification of pedicle screws encroaching on vascular structures thereby facilitating early revision surgery., Level of Evidence: 4.

Objective: Adjacent segment disease (ASD) may occur as a long-term consequence of spinal fusion and is associated with significant back and leg pain. Surgical management of symptomatic ASD consists of neural decompression and extension of fusion. However, conflicting results have been reported with respect to the long-term clinical effectiveness of revision surgery in this setting. We set out to comprehensively assess the long-term clinical outcome after revision surgery and determine its effectiveness in the treatment of adjacent segment disease., Methods: Fifty patients undergoing revision surgery for ASD-associated back and leg pain were included in this study. Baseline and 2-year Visual Analog Scale-Back Pain (VAS-BP), Visual Analog Scale-Leg Pain (VAS-LP), Oswestry Disability Index, physical and mental quality of life (Short Form-12 [SF-12] physical and mental component score [PCS and MCS]) and health-state utility (EuroQol [EQ-5D]) were assessed., Results: A sustained improvement in VAS-BP (8.72 ± 1.85 vs. 3.92 ± 2.84, P = 0.001), VAS-LP (6.30 ± 3.90 vs. 3.02 ± 3.03, P = 0.001), Oswestry Disability Index (28.72 ± 9.64 vs. 18.48 ± 11.31, P = 0.001), SF-12 PCS (26.89 ± 8.85 vs. 35.58 ± 11.97, P = 0.001) and SF-12 MCS (44.66 ± 12.85 vs. 53.16 ± 9.46, P = 0.001) was observed 2 years after revision surgery, with a cumulative mean 2-year gain of 0.76 quality-adjusted life-years (EQ-5D). Median (interquartile range) time to narcotic independence and return to work was 1.7 (1.0-8.0) months and 2.0 (1.0-4.75) months, respectively., Conclusions: Patients undergoing decompression and extension of fusion for adjacent segment disease-associated back and leg pain reported long-term improvement in pain, disability, and both physical and mental quality of life, suggesting that revision surgery is a highly effective treatment strategy in this patient population., (Copyright © 2013. Published by Elsevier Inc.)

Object: Surgical site infection (SSI) is a morbid complication with high cost in spine surgery. In this era of health care reforms, adjuvant therapies that not only improve quality but also decrease cost are considered of highest value. The authors introduced local application of vancomycin powder into their practice of posterior spinal fusion for spine trauma and undertook this study to determine the value and cost benefit of using vancomycin powder in surgical sites to prevent postoperative infections., Methods: A retrospective review of 110 patients with traumatic spine injuries treated with instrumented posterior spine fusions over a 2-year period at a single institution was performed. One group (control group) received standard systemic prophylaxis only, whereas another (treatment group) received 1 g of locally applied vancomycin powder (spread over the surgical wound) in addition to systemic prophylaxis. Data were collected on patient demographic characteristics, clinical variables, surgical variables, and 90-day morbidity. Incidence of infection was the primary outcome evaluated, and billing records were reviewed to determine total infection-related medical cost (cost of reoperation/wound debridement, medications, and diagnostic tests). The payer's cost was estimated to be 70% of the total billing cost., Results: A total of 110 patients were included in the study. The control (n = 54) and treatment groups (n = 56) were similar at baseline. Use of vancomycin powder led to significant reduction in infection rate (13% infection rate in the control group vs 0% in the treatment group, p = 0.02). There were no adverse effects noted from the use of vancomycin powder. The total mean cost of treating postoperative infection per patient was $33,705. Use of vancomycin powder led to a cost savings of $438,165 per 100 posterior spinal fusions performed for traumatic injuries., Conclusions: The use of adjuvant vancomycin powder was associated with a significant reduction in the incidence of postoperative infection as well as infection-related medical cost. These findings suggest that use of adjuvant vancomycin powder in high-risk patients undergoing spinal fusion is a cost-saving option for preventing postoperative infections, as it can lead to cost-savings of $438,165 per 100 spinal fusions performed.

Object: Treatment effectiveness following spine surgery is usually gauged with the help of patient-reported outcome (PRO) questionnaires. Although these questionnaires assess pain, disability, and general health state, their numerical scores lack direct, clinically significant meaning. Thus, the concept of minimum clinically important difference (MCID) has been introduced, which indicates the smallest change in an outcome measure that reflects clinically meaningful improvement to patients. The authors set out to determine anterior cervical discectomy and fusion (ACDF)-specific MCID values for the visual analog scale (VAS), Neck Disability Index (NDI), 12-Item Short-Form Health Survey (SF-12), and EQ-5D (the EuroQol health survey) in patients undergoing ACDF for cervical radiculopathy., Methods: Data on 69 patients who underwent ACDF for cervical radiculopathy were collected in the authors' web-based, prospective registry during the study enrollment period. Patient-reported outcome questionnaires (VAS-neck pain [NP]), VAS-arm pain [AP], NDI, SF-12, and EQ-5D) were administered preoperatively and 3 months postoperatively, allowing 3-month change scores to be calculated. Four established calculation methods were used to calculate anchor-based MCID values using the North American Spine Society (NASS) patient satisfaction scale as the anchor: 1) average change, 2) minimum detectable change (MDC), 3) change difference, and 4) receiver operating characteristic (ROC) curve analysis., Results: Sixty-one patients (88%) were available at follow-up. At 3 months postoperatively, statistically significant improvement (p < 0.001) was observed for the following PROs assessed: VAS-NP (2.7 ± 3.3), VAS-AP (3.7 ± 3.6), NDI (23.2% ± 19.7%), SF-12 physical component score (PCS; 10.7 ± 9.7), and EQ-5D (0.20 ± 0.23 QALY). Improvement on the SF-12 mental component score (MCS) trended toward significance (3.4 ± 11.4, p = 0.07). The 4 MCID calculation methods generated a range of MCID values for each of the PROs: VAS-NP 2.6-4.0, VAS-AP 2.4-4.2, NDI 16.0%-27.6%, SF-12 PCS 7.0-12.2, SF-12 MCS 0.0-7.2, and EQ-5D 0.05-0.24 QALY. The maximum area under the curve (AUC) was observed for NDI (0.80), and the minimum AUC was observed for SF-12 MCS (0.66) and EQ-5D (0.67). Based on the MDC approach, the MCID threshold was 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D. The mean improvement in patient scores at 3 months surpassed the MCID threshold for VAS-NP, NDI, and SF-12 PCS but not for VAS-AP, SF-12 MCS, and EQ-5D., Conclusions: The ACDF-specific MCID is highly variable depending on the calculation technique used. The MDC approach seems to be most appropriate for MCID calculations in the ACDF population, as it provided a threshold value above the 95% confidence interval of nonresponders (greater than the measurement error) and was closest to the average change of most PROs reported by responders. When the MDC method was applied with the NASS patient satisfaction scale as the anchor, the MCID thresholds were 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D.

Background: Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients., Objective: To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED)., Methods: Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50,000/QALY and < $75,000/QALY. MCID was determined with the health transition item as the anchor., Results: Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42,854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43,560 vs. $112,087), visual analog scale for back pain ($41,280 vs. $129,440), Oswestry disability index ($30,954 vs. $121,750), and EuroQol 5D ($35,800 vs. $189,412)., Conclusion: MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of <  $50,000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry disability index, and 0.31 QALYs for EuroQol 5D.

Background Context: Spinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis., Purpose: To determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis. STUDY DESIGN/ SETTING: Retrospective cohort study., Methods: In 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index)., Results: All patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0-3.2; ODI: 4.0%-16.6%; SF-12 PCS: 3.2-6.1; and EQ-5D: 0.14-0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state., Conclusions: Using subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Purpose of Study: Low back pain is one of the most prevalent and disabling musculoskeletal conditions affecting the working population in the United States. Informed, shared decision making among patients, clinicians, and case managers about treatment options for chronic low back pain-including the role of spinal fusion where medically necessary-can have a meaningful impact on return to work, normal function, and economic outcomes. Minimally invasive techniques for lumbar spinal fusion, including transforaminal lumbar interbody fusion (MIS TLIF) have recently been introduced with the goal of smaller operative wounds, less tissue trauma, and faster postoperative recovery when compared with open fusion. Although similar long-term clinical outcomes have been reported for MIS TLIF and open TLIF, the relative merits with respect to workplace productivity have not been comprehensively investigated. Time to return to work and narcotic independence after MIS TLIF and open TLIF are important parameters that may affect overall workplace productivity, and as such are the focus of this study., Primary Practice Setting(s): This study was performed via a review of the literature., Methodology and Sample: We performed a systematic literature review to identify all published articles that reported on the postoperative outcomes of patients, as assessed by return to work or narcotic independence status or both, following MIS TLIF or open TLIF. A cumulative comparison was made for all included MIS TLIF versus open TLIF surgeries., Results: Seventy-four published studies reported postoperative outcomes following MIS TLIF or open TLIF; only five (6.8%) studies directly described time to return to work or duration of narcotic use postoperatively or both, and were therefore included into the analysis of this review. Four studies in the published literature describe time to return to work following MIS TLIF or open TLIF, and two studies describe time to narcotic independence. Overall, the reviewed literature suggests that MIS TLIF may be associated with an accelerated time to narcotic independence and return to work versus open TLIF., Implications for Case Management Practice: There are limited data regarding time to return to work and duration of postoperative narcotic use following TLIF for low back pain. The available data appear to suggest that MIS TLIF may be associated with accelerated return to work and narcotic independence compared with open TLIF. Further analysis will be necessary to quantify the impact of MIS TLIF on workplace productivity and the indirect costs borne by patients and employers. Such information will be of value to case managers, disability managers, employers, patients, and clinicians aligned on reducing morbidity and hastening return to normal function.

Objective: Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) for lumbar spondylolisthesis allows for surgical treatment of back and leg pain while theoretically minimizing tissue injury and accelerating overall recovery. Although the authors of previous studies have demonstrated shorter length of hospital stay and reduced blood loss with MIS versus open-TLIF, short- and long-term outcomes have been similar. No studies to date have evaluated the comprehensive health care costs associated with TLIF procedures or assessed the cost-utility of MIS- versus open-TLIF. As such, we set out to assess previously unstudied end points of health care cost and cost-utility associated with MIS- versus open-TLIF., Methods: Thirty patients undergoing MIS-TLIF (n=15) or open-TLIF (n=15) for grade I degenerative spondylolisthesis associated back and leg pain were prospectively studied. Total back-related medical resource use, missed work, and health-state values (quality-adjusted life years [QALYs], calculated from EQ-5D with U.S. valuation) were assessed after two-year follow-up. Two-year resource use was multiplied by unit costs on the basis of Medicare national allowable payment amounts (direct cost) and work-day losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Difference in mean total cost per QALY gained for MIS- versus open-TLIF was assessed as incremental cost-effectiveness ratio (ICER: COSTmis-COSTopen/QALYmis-QALYopen)., Results: MIS versus open-TLIF cohorts were similar at baseline. By two years postoperatively, patients undergoing MIS- versus open-TLIF reported similar mean QALYs gained (0.50 vs. 0.41, P=0.17). Mean total two-year cost of MIS- and open-TLIF was $35,996 and $44,727, respectively. The $8,731 two-year cost savings of MIS- versus open-TLIF did not reach statistical significance (P=0.18) for this sample size., Conclusions: Although our limited sample size prevented statistical significance, MIS- versus open-TLIF was associated with reduced costs over two years while providing equivalent improvement in QALYs. MIS-TLIF allows patients to leave the hospital sooner, achieve narcotic independence sooner, and return to work sooner than open-TLIF. In our experience, MIS- versus open-TLIF is a cost reducing technology in the surgical treatment of medically refractory low-back and leg pain from grade I lumbar spondylolisthesis., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Object: Spine surgery outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect, but the extent of improvement in the numerical scores of these questionnaires lacks a direct clinical meaning. Because of this, the concept of a minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of same-level recurrent stenosis following index lumbar fusion, which commonly requires revision decompression and fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for this pathology., Methods: In 53 consecutive patients undergoing revision surgery for same-level recurrent lumbar stenosis-associated back and leg pain, PRO measures of back and leg pain were assessed preoperatively and 2 years postoperatively, using the visual analog scale for back pain (VAS-BP) and leg pain (VAS-LP), Oswestry Disability Index (ODI), Physical and Mental Component Summary categories of the 12-Item Short Form Health Survey (SF-12 PCS and MCS) for quality of life, Zung Depression Scale (ZDS), and EuroQol-5D health survey (EQ-5D). Four established anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for 2 separate anchors (health transition index of the SF-36 and the satisfaction index)., Results: All patients were available for 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs assessed. The 4 MCID calculation methods generated a range of MCID values for each of the PROs (VAS-BP 2.2-6.0, VAS-LP 3.9-7.5, ODI 8.2-19.9, SF-12 PCS 2.5-12.1, SF-12 MCS 7.0-15.9, ZDS 3.0-18.6, and EQ-5D 0.29-0.52). Each patient answered synchronously for the 2 anchors, suggesting both of these anchors are equally appropriate and valid for this patient population., Conclusions: The same-level recurrent stenosis surgery-specific MCID is highly variable based on calculation technique. The "minimum detectable change" approach is the most appropriate method for calculation of MCIDs in this population because it was the only method to reliably provide a threshold above the 95% confidence interval of the unimproved cohort (greater than the measurement error). Based on this method, the MCID thresholds following neural decompression and fusion for symptomatic same-level recurrent stenosis are 2.2 points for VAS-BP, 5.0 points for VAS-LP, 8.2 points for ODI, 2.5 points for SF-12 PCS, 10.1 points for SF-12 MCS, 4.9 points for ZDS, and 0.39 QALYs for EQ-5D.

Object: Revision lumbar fusion procedures are technically challenging and can be associated with tremendous health care resource utilization and cost. There is a paucity of data regarding specific factors that significantly contribute to increased cost of care. In light of this, the authors set out to identify independent risk factors predictive of increasing 2-year direct health care costs after revision lumbar fusion., Methods: One hundred fifty patients undergoing revision instrument-assisted fusion for adjacent-segment disease (50 cases), pseudarthrosis (47 cases), or same-level stenosis (53 cases) were included in this study. Patient demographics, comorbidities, preoperative health states as assessed by patient-reported outcome questionnaires and perioperative complications were collected and analyzed. Two-year back-related medical resource utilization and direct health care costs were assessed. The independent association of all variables to increasing cost was assessed using multivariate linear regression analysis., Results: There was a wide range ($24,935-$63,769) in overall 2-year direct costs for patients undergoing revision lumbar fusion (mean $32,915 ± $8344 [± SD]). Preoperative variables independently associated with 2-year direct health care costs included diagnosis of congestive heart failure, more severe leg pain (visual analog scale), greater back-related disability (Oswestry Disability Index), and worse mental health (12-Item Short Form Health Survey Mental Component Summary score). There was a 1.1- to 1.2-fold increase in cost for patients in the greatest quartiles compared with those in the lowest quartiles for these variables. Surgical site infection, return to the operating room, and spine-related hospital readmission during the 90-day global health period were postoperative variables independently associated with 2-year cost. Patients in the greatest versus lowest quartiles had a 1.7- to 1.9-fold increase in cost for these variables., Conclusions: Revision lumbar fusion can be associated with considerable 2-year health care costs. These costs can also vary widely among patients, as evidenced by the 2.6-fold overall cost range in this series. Although comorbidities and preoperative severity of disease states contribute to cost of care, the primary drivers of increased cost include perioperative complications such as surgical site infection, return to the operating room, and readmission during the global health period. Measures focused on health service improvement will be most successful in reducing the cost of care for patients undergoing revision lumbar fusion.

Background Context: Persistent back pain and leg pain after index surgery is distressing to patients and spinal surgeons. Revision surgical treatment is technically challenging and has been reported to yield unpredictable outcomes. Recently, affective disorders, such as depression and anxiety, have been considered potential predictors of surgical outcomes across many disease states of chronic pain. There remains a paucity of studies assessing the predictive value of baseline depression on outcomes in the setting of revision spine surgery., Purpose: To assess the predictive value of preoperative depression on 2-year postoperative outcome after revision lumbar surgery for symptomatic pseudarthrosis, adjacent segment disease (ASD), and same-level recurrent stenosis., Study Design: Retrospective cohort study., Patient Sample: One hundred fifty patients undergoing revision surgery for symptomatic ASD, pseudarthrosis, and same-level recurrent stenosis., Outcome Measures: Patient-reported outcome measures were assessed using an outcomes questionnaire that included questions on health-state values (EQ-5D), disability (Oswestry Disability Index [ODI]), pain (visual analog scale), depression (Zung Self-Rating Depression Scale), and 12-Item Short Form Health Survey physical and mental component scores., Methods: One hundred fifty patients undergoing revision neural decompression and instrumented fusion for ASD (n=50), pseudarthrosis (n=47), or same-level recurrent stenosis (n=53) were included in this study. Preoperative Zung Self-Reported Depression Scale score was assessed for all patients. Preoperative and 2-year postoperative visual analog scale for back pain and leg pain scores and ODI were assessed. The association between preoperative Zung Depression Scale score and 2-year improvement in disability was assessed via multivariate regression analysis., Results: Compared to preoperative status, VAS-BP was significantly improved 2 years after surgery for ASD (8.72±1.85 vs. 3.92±2.84, p=.001), pseudoarthrosis (7.31±0.81 vs. 5.06±2.64, p=.001), and same-level recurrent stenosis (9.28±1.00 vs. 5.00±2.94, p=.001). Two-year ODI was also significantly improved after surgery for ASD (28.72±9.64 vs. 18.48±11.31, p=.001), pseudoarthrosis (29.74±5.35 vs. 25.42±6.00, p=.001), and same-level recurrent stenosis (36.01±6.00 vs. 21.75±12.07, p=.001). Independent of age, BMI, symptom duration, smoking, comorbidities, and level of preoperative pain and disability, increasing preoperative Zung depression score was significantly associated with less 2-year improvement in disability (ODI) after revision surgery for ASD, pseudoarthrosis, and recurrent stenosis., Conclusions: Our study suggests that the extent of preoperative depression is an independent predictor of functional outcome after revision lumbar surgery for ASD, pseudoarthrosis, and recurrent stenosis. Future comparative effectiveness studies assessing outcomes after revision lumbar surgery should account for depression as a potential confounder. The Zung depression questionnaire may help risk stratify patients presenting for revision lumbar surgery., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Object: Despite advances in technology and understanding in spinal physiology, reoperation for symptomatic same-level recurrent stenosis continues to occur. Although revision lumbar surgery is effective, attention has turned to the question of the utility and value of revision decompression and fusion procedures. To date, an analysis of cost and heath state gain associated with revision lumbar surgery for recurrent same-level lumbar stenosis has yet to be described. The authors set out to assess the 2-year comprehensive cost of revision surgery and determine its value in the treatment of same-level recurrent stenosis., Methods: Forty-two patients undergoing revision decompression and instrumented fusion for same-level recurrent stenosis-associated leg and back pain were included in this study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed., Results: The mean (± SD) interval between prior and revision surgery was 4.16 ± 4.64 years. Bone morphogenetic protein was used in 7 cases of revision arthrodesis (16.7%). A mean cumulative 2-year gain of 0.84 QALY was observed after revision surgery. The mean total 2-year cost of revision fusion was $49,431 ± $7583 (surgery cost $21,060 ± $4459; outpatient resource utilization cost $9748 ± $5292; indirect cost $18,623 ± $9098). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $58,846., Conclusions: In the authors' practice, revision decompression and fusion provided a significant gain in health state utility for patients with symptomatic same-level recurrent stenosis, with a 2-year cost per QALY gained of $58,846. When indicated, revision surgery for same-level recurrent stenosis is a valuable treatment option for patients experiencing back and leg pain secondary to this disease. The authors' findings provide a value measure of surgery that can be compared with the results of future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Object: Over the past decade, there has been a dramatic increase in the number of spinal fusions performed in the US and a corresponding increase in the incidence of adjacent-segment disease (ASD). Surgical management of symptomatic ASD consists of decompression of neural elements and extension of fusion. It has been shown to have favorable long-term outcomes, but the cost-effectiveness remains unclear. In this study, the authors set out to assess the cost-effectiveness of revision surgery in the treatment of ASD over a 2-year period., Methods: Fifty patients undergoing neural decompression and extension of fusion construct for ASD-associated back and leg pain were included in the study. Two-year total back-related medical resource utilization, missed work, and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Mean total 2-year cost per QALY gained after revision surgery was assessed., Results: The mean (± SD) interval between prior fusion and revision surgery for ASD was 3.07 ± 2.02 years. A mean cumulative 2-year gain of 0.76 QALYs was observed after revision surgery. The mean total 2-year cost of extension of fusion constructs was $47,846 ± $32,712 (surgery cost: $24,063 ± $300; outpatient resource utilization cost: $4175 ± $3368; indirect cost: $19,607 ± $32,187). Revision decompression and extension of fusion was associated with a mean 2-year cost per QALY gained of $62,955., Conclusions: In the authors' practice, revision decompression and extension of fusion provided a significant gain in health state utility for patients with symptomatic ASD, with a 2-year cost per QALY gained of $62,995. When indicated, revision surgery for ASD is a valuable treatment option for patients experiencing back and leg pain secondary to ASD. The findings provide a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Object: Spinal surgical outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lack a direct clinical meaning. As a result, the concept of minimum clinical important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of adjacent-segment degeneration following index lumbar fusion, which commonly requires revision laminectomy and extension of fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for adjacent-segment disease (ASD)., Methods: In 50 consecutive patients undergoing revision surgery for ASD-associated back and leg pain, PRO measures of back and leg pain on a visual analog scale (BP-VAS and LP-VAS, respectively), Oswestry Disability Index (ODI), 12-Item Short Form Health Survey Physical and Mental Component Summaries (SF-12 PCS and MCS, respectively), and EuroQol-5D health survey (EQ-5D) were assessed preoperatively and 2 years postoperatively. The following 4 well-established anchor-based MCID calculation methods were used to calculate MCID: average change; minimum detectable change (MDC); change difference; and receiver operating characteristic curve (ROC) analysis for the following 2 separate anchors: health transition item (HTI) of the SF-36 and satisfaction index., Results: All patients were available for 2-year PRO assessment. Two years after surgery, a statistically significant improvement was observed for all PROs (mean changes: BP-VAS score [4.80 ± 3.25], LP-VAS score [3.28 ± 3.25], ODI [10.24 ± 13.49], SF-12 PCS [8.69 ± 12.55] and MCS [8.49 ± 11.45] scores, and EQ-5D [0.38 ± 0.45]; all p < 0.001). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS score, 2.3-6.5; LP-VAS score, 1.7-4.3; ODI, 6.8-16.9; SF-12 PCS, 6.1-12.6; SF-12 MCS, 2.4-10.8; and EQ-5D, 0.27-0.54). The area under the ROC curve was consistently greater for the HTI anchor than the satisfaction anchor, suggesting this as a more accurate anchor for MCID., Conclusions: Adjacent-segment disease revision surgery-specific MCID is highly variable based on calculation technique. The MDC approach with HTI anchor appears to be most appropriate for calculation of MCID after revision lumbar fusion for ASD because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was not significantly affected by choice of anchor. Based on this method, MCID following ASD revision lumbar surgery is 3.8 points for BP-VAS score, 2.4 points for LP-VAS score, 6.8 points for ODI, 8.8 points for SF-12 PCS, 9.3 points for SF-12 MCS, and 0.35 quality-adjusted life-years for EQ-5D.

Study Design: Retrospective cohort comparison between minimally invasive (MIS) and open transforaminal lumbar interbody fusion (TLIF)., Objective: To assess 2 earlier unstudied endpoints (duration of narcotic use and return to work) and long-term pain, disability, and quality of life (QOL) for MIS-TLIF versus open-TLIF., Summary of Background Data: MIS-TLIF for lumbar spondylolithesis theoretically allows for surgical treatment of back and leg pain while minimizing blood loss and tissue injury. Although earlier studies have shown shorter hospital stay and equivocal 6 and 24 month outcomes with MIS-TLIF versus open-TLIF, the effect of MIS techniques on postoperative narcotic use and return to work are poorly understood., Methods: Thirty patients undergoing MIS-TLIF (n = 15) or open-TLIF (n = 15) for grade I degenerative spondylolithesis-associated back and leg pain were enrolled. Two-year outcomes were assessed through phone interview and it included pain [visual analog scale (VAS)], low-back disability (Oswestry disability index), EuroQol-5D, occupational disability, and narcotic use., Results: MIS-TLIF versus open-TLIF cohorts were similar at baseline. Median [interquartile range (IQR)] length of hospitalization after surgery was significantly less for MIS-TLIF versus open-TLIF [3 (3 to 3) vs 5.5 (4 to 6) d], P = 0.001. MIS-TLIF versus open-TLIF patients showed similar 2-year improvement in VAS for back pain, VAS for leg pain, Oswestry disability index, and EuroQol-5D scores. Overall, median (IQR) length of postoperative narcotic use was 3.0 (1.4 to 4.6) weeks and significantly shorter for MIS-TLIF versus open-TLIF patients [2.0 (1.0 to 3.0) vs 4.0 (1.4 to 4.6) wk, P = 0.008]. Overall, median (IQR) time to return to work was 13.9 (2.2 to 25.5) weeks and significantly shorter for MIS-TLIF versus open-TLIF patients [8.5 (4.4 to 21.4) vs 17.1 (1.8 to 35.9) wk, P = 0.02]., Conclusions: Both MIS-TLIF and open-TLIF provide long-term improvement in pain, disability, and EuroQol-5D in patients with back and leg pain from grade I degenerative spondylolithesis. However, MIS-TLIF may allow for shortened hospital stays, reduced postoperative narcotic use, and accelerated return to work, reducing both direct medical costs and indirect costs of lost work productivity associated with TLIF procedures.

Object: The number of low-back fusion procedures for the treatment of spine disorders has increased steadily over the past 10 years. Lumbar pseudarthrosis is a potential complication of lumbar arthrodesis and can be associated with significant pain and disability. The aim of this study was to assess, using validated patient-reported outcomes measures, the long-term effectiveness of revision arthrodesis in the treatment of symptomatic pseudarthrosis., Methods: This is a retrospective study of 47 patients who underwent revision lumbar arthrodesis for pseudarthrosis-associated back pain. Baseline 2-year outcomes were assessed using the following: visual analog scale (VAS) for back pain, Oswestry Disability Index (ODI), Zung Self-Rating Depression Scale, time to narcotic independence, time to return to work, EuroQol health-state utility, and physical and mental quality of life (Short Form [SF]-12 Physical and Mental Component Summary scores)., Results: The mean duration of time between prior fusion and development of symptomatic pseudarthrosis was 2.69 years. Bone morphogenetic protein was used in 4 cases (8.5%) of revision arthrodesis. A significant improvement in VAS back pain (7.31 ± 0.81 vs 5.06 ± 2.64, p = 0.001), ODI (29.74 ± 5.35 vs 25.42 ± 6.0, p = 0.001), and physical health SF-12 (23.83 ± 6.89 vs 27.85 ± 8.90, p = 0.001) scores was observed when comparing baseline and 2-year post-revision arthrodesis scores, respectively, with a mean cumulative 2-year gain of 0.35 quality-adjusted life years. The median time to narcotics independence was 12.16 (interquartile range 1.5-24.0) months and the median time to return to work was 4 months (interquartile range 3-5 months). By 2 years after revision surgery, no patients had experienced pseudarthrosis. The SF-12 Mental Component Summary (44.72 ± 7.90 vs 43.46 ± 7.51, p = 0.43) and Zung Self-Rating Depression Scale scores (39.36 ± 7.48 vs 41.39 ± 10.72, p = 0.37) were not significantly improved by 2 years., Conclusions: The authors' study suggests that revision lumbar arthrodesis for symptomatic pseudarthrosis provides improvement in low-back pain, disability, and quality of life. Revision lumbar arthrodesis should be considered a viable treatment option for patients with pseudarthrosis-related back pain. Mental health symptoms from pseudarthrosis-associated back pain may be more refractory to revision surgery.

Object: Transforaminal lumbar interbody fusion (TLIF) for spondylolisthesis-associated back and leg pain is associated with improvement in pain, disability, and quality of life. However, given the rising health care costs associated with spinal fusion procedures and varying results of recent cost-utility studies, the cost-effectiveness of TLIF remains unclear. The authors set out to assess the comprehensive costs of TLIF at their institution and to determine its cost-effectiveness in the treatment of degenerative spondylolisthesis., Methods: Forty-five patients undergoing TLIF for Grade I degenerative spondylolisthesis-associated back and leg pain after 6-12 months of conservative therapy were included. The authors assessed the 2-year back pain visual analog scale (VAS) score, leg pain VAS score, Oswestry Disability Index, and total back-related medical resource utilization, missed work, and health-state values (quality-adjusted life years [QALYs], calculated from EQ-5D with US valuation). Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost), and patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after TLIF was assessed., Results: Compared with preoperative health states reported after at least 6 months of medical management, a significant improvement in back pain VAS score, leg pain VAS score, and Oswestry Disability Index was observed 2 years after TLIF, with a mean 2-year gain of 0.86 QALYs. The mean ± SD total 2-year cost of TLIF was $36,836 ± $11,800 (surgery cost, $21,311 ± $2800; outpatient resource utilization cost, $3940 ± $2720; indirect cost, $11,584 ± $11,363). Transforaminal lumbar interbody fusion was associated with a mean 2-year cost per QALY gained of $42,854., Conclusions: Transforaminal lumbar interbody fusion improved pain, disability, and quality of life in patients with degenerative spondylolisthesis-associated back and leg pain. The total cost per QALY gained for TLIF was $42,854 when evaluated 2 years after surgery with Medicare fees, suggesting that TLIF is a cost-effective treatment of lumbar spondylolisthesis.

Object: Pedicle screws provide efficient stabilization along all 3 columns of the spine, but they can be technically demanding to place, with malposition rates ranging from 5% to 10%. Intraoperative electromyographic (EMG) monitoring has the capacity to objectively identify a screw breaching the medial pedicle cortex that is in proximity to a nerve root. The purpose of this study is to describe and evaluate the authors' 7-year institutional experience with intraoperative EMG monitoring during placement of lumbar pedicle screws and to determine the clinical utility of intraoperative EMG monitoring., Methods: The authors retrospectively studied 2450 consecutive lumbar pedicle screws placed in 418 patients from June 2002 through June 2009. All screws were inserted using a free-hand technique and anatomical landmarks, stimulated at 10.0 mA, and evaluated with CT scanning within 48 hours postoperatively. Medial pedicle screw breach was defined as having greater than 25% of the screw diameter extend outside of the pedicle, as confirmed on CT scanning or intraoperatively by a positive EMG response indicating a medial breach. The sensitivity and specificity of intraoperative EMG monitoring in detecting the presence of a medial screw breach was evaluated based on the following definitions: 1) true positive (a positive response to EMG stimulation confirmed as a breach intraoperatively or on postoperative CT scans); 2) false positive (positive response to EMG stimulation confirmed as a correctly positioned screw on postoperative CT scans); 3) true negative (no response to EMG stimulation confirmed as a correctly positioned screw on postoperative CT scans); or 4) false negative (no response to EMG stimulation but confirmed as a breach on postoperative CT scans)., Results: One hundred fifteen pedicle screws (4.7%) showed positive stimulation during intraoperative EMG monitoring. At stimulation thresholds less than 5.0, 5.0-8.0, and > 8.0 mA, the specificity of a positive response was 99.9%, 97.9%, and 95.9%, respectively. The sensitivity of a positive response at these thresholds was only 43.4%, 69.6%, and 69.6%, respectively. At a threshold less than 5.0 mA, 91% of screws with a positive EMG response were confirmed as true medial breaches. However, at thresholds of 5.0-8.0 mA or greater than 8.0 mA, a positive EMG response was associated with 89% and 100% false positives (no breaches), respectively., Conclusions: When using intraoperative EMG monitoring, a positive response at screw stimulation thresholds less than 5.0 mA was highly specific for a medial pedicle screw breach but was poorly sensitive. A positive response to stimulation thresholds greater 5.0 mA was associated with a very high rate of false positives. The authors' experience suggests that pedicle screws showing positive stimulation below 5.0 mA warrants intraoperative investigation for malpositioning while responses at higher thresholds are less reliable at accurately representing a medial breach.

Object: Surgical site infection (SSI) after lumbar fusion results in significant patient morbidity and associated medical resource utilization. Minimally invasive (MI) techniques for posterior/transforaminal lumbar interbody fusion (P/TLIF) were introduced with the goals of smaller wounds, less tissue trauma, reduced blood loss, and quicker postoperative recovery, while maintaining comparable surgical results. Studies with sufficient power to directly compare the incidence of SSI following MI versus open P/TLIF procedures have been lacking. Furthermore, the direct medical cost associated with the treatment of SSI following the P/TLIF procedure is poorly understood and has not been adequately assessed. Thus, the aim in the present study was to determine the incidence of perioperative SSI in patients undergoing MI versus open P/TLIF and the direct hospital cost associated with the diagnosis and management of SSI after P/TLIF as reported in a large administrative database., Methods: The authors retrospectively reviewed hospital discharge and billing records from the Premier Perspective Database for 2003 to 2009 to identify patients undergoing 1- or 2-level MI or open P/TLIF for lumbar spondylotic disease, disc degeneration, or spondylolisthesis. The ICD-9-CM procedure codes were used to identify patients undergoing P/TLIF and those experiencing SSI. Infection-related costs were obtained from the total costs incurred by the hospital for SSI-related care provided during inpatient or hospital outpatient encounters., Results: Five thousand one hundred seventy patients undergoing P/TLIF were identified. Demographic profiles, including the Charlson Comorbidity Index, were similar between MI and open cohorts. Overall, 292 patients (5.6%) experienced an SSI with a mean direct cost of $15,817 per SSI. For 1-level MI versus open P/TLIF, the incidence of SSI (38 [4.5%] vs 77 [4.8%], p = 0.77) and the mean SSI-associated cost per P/TLIF ($684 vs $724, p = 0.680) were similar. For 2-level MI versus open P/TLIF, the incidence of SSI (27 [4.6%] vs 150 [7.0%], p = 0.037) and mean SSI-associated cost per P/TLIF ($756 vs $1140, p = 0.030) were both significantly lower among MI-treated patients. In a multivariate model that accounted for differences in demographics and patient severity, open fusion was associated with a strong trend of increased incidence of SSI as compared with MI fusion (OR 1.469, 95% CI 0.959-2.250)., Conclusions: In this multihospital study, the MI technique was associated with a decreased incidence of perioperative SSI and a direct cost savings of $38,400 per 100 P/TLIF procedure when used in 2-level fusion. There was no significant difference in the incidence of SSIs between the open and MI cohorts for 1-level fusion procedures. The results of this study provide further evidence of the reduced patient morbidity and health care costs associated with MI P/TLIF.

Object: Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice., Methods: In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index [HTI] of the 36-Item Short Form Health Survey [SF-36], and the satisfaction index)., Results: All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1-5.3; LP-VAS, 2.1-4.7; ODI, 11-22.9; and EQ-5D, 0.15-0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI [AUC 0.73] vs satisfaction [AUC 0.69]), suggesting HTI as a more accurate anchor., Conclusions: The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.

Introduction: Surgical site infection (SSI) in the setting of lumbar fusion is associated with significant morbidity and medical resource utilization. To date, there have been no studies conducted with sufficient power to directly compare the incidence of SSI following minimally invasive (MIS) vs. open TLIF procedures. Furthermore, studies are lacking that quantify the direct medical cost of SSI following fusion procedures. We set out to determine the incidence of SSI in patients undergoing MIS vs. open TLIF reported in the literature and to determine the direct hospital cost associated with the treatment of SSI following TLIF at our institution., Methods: A systematic Medline search was performed to identify all published studies assessing SSI after MIS or open TLIF. The cumulative incidence of SSI was calculated from all reported cohorts and compared between MIS vs. open TLIF. In order to determine the direct hospital costs associated with the treatment of SSI following TLIF, we retrospectively reviewed 120 consecutive TLIFs performed at our institution, assessed the incidence of SSI, and calculated the SSI-related hospital costs from accounting and billing records., Results: To date, there have been 10 MIS-TLIF cohorts (362 patients) and 20 open-TLIF cohorts (1 133 patients) reporting incidences of SSI. The cumulative incidence of reported SSI was significantly lower for MIS vs. open-TLIF (0.6% vs. 4.0%, p=0.0005). In our experience with 120 open TLIF procedures, SSI occurred in 6 (5.0%) patients. The mean hospital cost associated with the treatment of SSI following TLIF was $ 29,110 in these 6 cases. The 3.4% decrease in reported incidence of SSI for MIS vs. open-TLIF corresponds to a direct cost savings of $ 98,974 per 100 MIS-TLIF procedures performed., Conclusions: Post-operative wound infections following TLIF are costly complications. MIS vs. open TLIF is associated with a decreased reported incidence of SSI in the literature and may be a valuable tool in reducing hospital costs associated with spine care., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Posterior lumbar interbody fusion (PLIF) and trans-foraminal lumbar interbody fusion (TLIF) are both accepted surgical approaches for spinal fusion in spondylolisthesis and degenerative disc disease. The unilateral approach of TLIF may minimize the risk of iatrogenic durotomy and nerve root injury; however, there is no definitive evidence to support either approach. We review our experience with TLIF versus PLIF to compare operative complications., Methods: We retrospectively reviewed 119 consecutive cases of PLIF or TLIF performed for degenerative disc disease or spondylolithesis at a single institution over 5 years and examined the incidences of operative complications and outcomes., Results: PLIF was performed in 76 (63%) patients and TLIF in 43 (37%). Patients were 48 ± 13 years old and presented with mechanical back pain [109 (92%)], radicular pain [95 (80%)], and radicular motor weakness [10 (8%)]. Patients undergoing PLIF and TLIF had similar baseline demographic, clinical, and radiographic characteristics. PLIF was associated with a higher incidence of post-operative iatrogenic nerve root dysfunction [6 (7.8%) versus 1 (2%)] and durotomy [13 (17%) versus 4 (9%)]; however, these differences did not reach statistical significance. All cases of nerve root injury were transient and resolved by the third month post-operatively. Estimated operative blood loss, length of hospitalization, and other peri-operative indices were similar between cohorts. By 12 months, evidence of pseudoarthrosis was present in 2 (2.6%) and 2 (4.6%) patients with PLIF or TLIF, respectively. There was a similar incidence of improvement in radicular pain (88% versus 79%) and low back pain (74% versus 80%) between TLIF and PLIF., Conclusion: In our experience with surgical management of degenerative disc disease and spondylolesthesis, PLIF versus TLIF was associated with a trend toward a higher incidence of nerve root injury and durotomy. However, iatrogenic nerve root dysfunction was transient in all cases and 12-month pseudoarthrosis rates were similar between cohorts. Similar to previous clinical studies, the incidence of neurological complications and durotomy increases when an interbody fusion is performed through a posterior approach compared to non-interbody fusion techniques. However, the fusion rates with the interbody technique are also enhanced. TLIF and PLIF should only be considered when the goals of surgery cannot be addressed with decompression and traditional posterolateral fusion.

Background: Pedicle screws are used to stabilize all 3 columns of the spine, but can be technically demanding to place. Although intraoperative fluoroscopy and stereotactic-guided techniques slightly increase placement accuracy, they are also associated with increased radiation exposure to patient and surgeon as well as increased operative time., Objective: To describe and critically evaluate our 7-year institutional experience with placement of pedicle screws in the thoracic and lumbar spine using a free-hand technique., Methods: We retrospectively reviewed records of all patients undergoing free-hand pedicle screw placement without fluoroscopy in the thoracic or lumbar spine between June 2002 and June 2009. Incidence and extent of cortical breach by misplaced pedicle screw was determined by review of postoperative computed tomography scans. We defined breach as more than 25% of the screw diameter residing outside of the pedicle or vertebral body cortex., Results: A total of 964 patients received 6816 free-hand placed pedicle screws in the thoracic or lumbar spine. Indications for hardware placement were degenerative/deformity disease (51.2%), spondylolisthesis (23.7%), tumor (22.7%), trauma (11.3%), infection (7.6%), and congenital (0.9%). A total of 115 screws (1.7%) were identified as breaching the pedicle in 87 patients (9.0%). Breach occurred more frequently in the thoracic than the lumbar spine (2.5% and 0.9%, respectively; P < .0001) and was more often lateral (61.3%) than medial (32.8%) or superior (2.5%). T4 (4.1%) and T6 (4.0%) experienced the highest breach rate, whereas L5 and S1 had the lowest breach rate. Eight patients (0.8%) underwent revision surgery to correct malpositioned screws., Conclusion: Free-hand pedicle screw placement based on external anatomy alone can be performed with acceptable safety and accuracy and allows avoidance of radiation exposure encountered in fluoroscopic techniques. Image-guided assistance may be most valuable when placing screws between T4 and T6, where breach rates are highest.

Study Design: A retrospective review study., Objective: In this study, we attempt to identify radiographic variables associated with likelihood of intraoperative breach during C2 pedicle screw placement. In addition, we attempt to correlate surgeon experience with breach rate., Summary of Background Data: Pedicle screws have emerged as an effective approach for obtaining fixation of the axis, yet placement of C2 pedicle screws is technically demanding and poses the risk of injury to the vertebral artery. Given the evidence for substantial variation in C2 anatomy, preoperative assessment of computed tomography (CT) scans may indicate, which patients are at increased risk for cortical breach during the pedicle screw placement., Materials and Methods: A retrospective review of all patients undergoing C2 pedicle screw fixation at a single institution over the last 6 years was conducted. Radiographic cortical breaches were defined on postoperative CT scans as visualization of the screw beyond the cortical edge. Radiographic measurements were determined from preoperative CT scans and were then correlated with breaches via Student t test. The association of breach rate with surgeon experience was evaluated using univariate linear regression., Results: Ninety-three patients underwent placement of 170 screws. Cortical breach was detected on postoperative CT scans in 43 screws (25.3%). One clinically significant breach occurred with damage to the left vertebral artery intraoperatively. On axial CT sections, mean pedicle isthmus diameter was significantly smaller in patients with breach than in patients without breach for both left and right sides, P=0.006 and P=0.010, respectively. Specifically, a diameter of less than 6 mm was associated with a nearly 2-fold increase in risk of cortical breach (37% vs. 21%). Surgeons with greater experience in placing C2 pedicle screws were noted to have a lower breach incidence (P=0.004)., Conclusions: During placement of C2 pedicle screws, likelihood of cortical breach may be associated with size of pedicle and surgeon experience. Extensive preoperative evaluation of CT scans and consideration of technical demands of procedure may help avoid complications with such internal fixation.

Objective: C2 translaminar (TL) screws rigidly capture the posterior elements of C2, avoid risk of vertebral artery injury, and are less technically demanding than C2 pedicle (PD) screws. However, a C2-TL screw breach places the spinal cord at risk, and the durability of C2-TL screws remains unknown. It is unclear if TL versus PD screw fixation of C2 is truly associated with less operative morbidity, greater accuracy of screw placement, or equivalent durability., Methods: We retrospectively reviewed the records of 167 consecutive patients undergoing posterior cervical fusion with either PD or TL screw fixation of C2. Perioperative morbidity, breach of the C2 lamina or pedicle on postoperative computed tomographic scans, and rates of operative revision were compared between PD and TL screw constructs in axial (C1-C2 or C1-C3) and subaxial (C2 and caudal) cervical fusions., Results: In total, 152 C2-TL screws and 161 C2-PD screws were placed in 167 patients. Thirty-one (19%) cases of axial cervical fusion (C1-C2 or C1-C3) were performed (mean age, 63.8 +/- 20.6 years) with either C2-TL (16 [52%]) or C2-PD (15 [48%]) screw fixation. One hundred thirty-six (81%) cases of subaxial cervical fusion (C2-caudal) were performed (mean age, 57.9 +/- 14.7 years) with either C2-TL (66 [49%]) or C2-PD (70 [51%]) screw fixation. For both axial and subaxial cervical fusions, baseline patient characteristics and all measures of perioperative morbidity were similar between C2-TL and C2-PD screw cohorts. In total, 11 (7%) PD screws breached the pedicle (0 requiring acute revision) versus only 2 (1.3%) TL screws that breached the C2 lamina (1 requiring acute revision) (P = 0.018). By 1 year postoperatively, pseudoarthrosis or screw pullout requiring reoperation was required in 4 (6.1%) patients with C2-TL screws versus 0 (0%) patients with PD screws (P < 0.05 for subaxial constructs). No cases of C2-TL or C2-PD axial fusion required reoperation or screw pullout or pseudoarthrosis., Conclusion: In our experience, radiographic breach of C2 pedicle screws occurred more frequently than C2 laminar screw breach. However, this was not associated with an increase in morbidity. By 12 months postoperatively, C2-TL screws were associated with a greater incidence of operative revision when used in subaxial constructs but similarly effective for axial cervical constructs. The 1-year durability of C2-TL screws might be inferior to C2 pedicle screws for subaxial fusions, but equally effective for axial cervical fusions.