A prospective multicenter randomized study comparing the SpineJack system and nonsurgical management with a brace in acute traumatic vertebral fractures: the SPICO study.

OBJECTIVE: The objective of this study was to evaluate the efffectiveness of a titanium vertebral augmentation device (SpineJack system) in terms of back pain, radiological outcomes, and economic burden compared with nonsurgical management (NSM) (bracing) for the treatment of vertebral compression fractures. Complications were also evaluated for both treatment methods. METHODS: A prospective multicenter randomized study was performed at 9 French sites. Patients (n = 100) with acute traumatic Magerl type A1 and A3.1 vertebral fractures were enrolled and randomized to treatment with the SpineJack system or NSM consisting of bracing and administration of pain medication. Participants were monitored at admission, during the procedure, and at 1, 12, and 24 months after treatment initiation. Primary outcomes included visual analog scale back pain score, and secondary outcomes included disability (Oswestry Disability Index [ODI] score), health-related quality of life (EQ-5D score), radiological measures (vertebral kyphosis angle [VKA] and regional traumatic angulation [RTA]), and economic outcomes (costs, procedures, hours of help, and time to return to work). RESULTS: Ninety-five patients were included in the analysis, with 48 in the SpineJack group and 47 in the NSM group. Back pain improved significantly for all participants with no significant differences between groups. ODI and EQ-5D scores improved significantly between baseline and follow-up (1, 12, and 24 months) for all participants, with the SpineJack group showing a larger improvement than the NSM group between baseline and 1 month. VKA was significantly lower (p < 0.001) (i.e., better) in the SpineJack group than in the NSM group at 1, 12, and 24 months of follow-up. There was no significant change over time in RTA for the SpineJack group, but the NSM group showed a significant worsening in RTA over time. SpineJack treatment was associated with higher costs than NSM but involved a shorter hospital stay, fewer medical visits, and fewer hours of nursing care. Time to return to work was significantly shorter for the SpineJack group than for the NSM group. There were no significant differences in complications between the two treatments. CONCLUSIONS: Overall, there was no statistical difference in the primary outcomes between the SpineJack treatment group and the NSM group. In terms of secondary outcomes, SpineJack treatment was associated with better radiological outcomes, shorter hospital stays, faster return to work, and fewer hours of nursing care.

A comparison of three different surgery approaches and methods for neurologically intact thoracolumbar fractures: a retrospective study.

OBJECTIVES: The purpose of this study was to evaluate and compare the feasibility, safety, and efficacy of conventional open pedicle screw fixation (COPSF), percutaneous pedicle screw fixation (PPSF), and paraspinal posterior open approach pedicle screw fixation (POPSF) for treating neurologically intact thoracolumbar fractures. METHODS: We retrospectively reviewed 108 patients who were posteriorly stabilized without graft fusion. Among them, 36 patients underwent COPSF, 38 patients underwent PPSF, and 34 patients underwent POPSF. The clinical outcomes, relative operation indexes, and radiological findings were assessed and compared among the 3 groups. RESULTS: All of the patients were followed up for a mean time of 20 months. The PPSF group and POPSF group had shorter operation times, lower amounts of intraoperative blood loss, and shorter postoperative hospital stays than the COPSF group (P < 0.05). The radiation times and hospitalization costs were highest in the PPSF group (P < 0.05). Every group exhibited significant improvements in the Cobb angle (CA) and the vertebral body angle (VBA) correction (all P < 0.05). The COPSF group and the POPSF group had better improvements than the PPSF group at 3 days postoperation and the POPSF group had the best improvements in the last follow-up (P < 0.05). CONCLUSION: Both PPSF and POPSF achieved similar effects as COPSF while also resulting in lower incidences of injury. PPSF is more advantageous in the early rehabilitation time period, compared with COPSF, but POPSF is a better option when considering the long-term effects, the costs of treatment, and the radiation times.

Time to Surgery for Unstable Thoracolumbar Fractures in Latin America-A Multicentric Study.

OBJECTIVE: We sought to identify delays for surgery to stabilize unstable thoracolumbar fractures and the main reasons for them across Latin America. METHODS: We reviewed the charts of 547 patients with type B or C thoracolumbar fractures from 21 spine centers across 9 Latin American countries. Data were collected on demographics, mechanism of trauma, time between hospital arrival and surgery, type of hospital (public vs. private), fracture classification, spinal level of injury, neurologic status (American Spinal Injury Association impairment scale), number of levels instrumented, and reason for delay between hospital arrival and surgical treatment. RESULTS: The sample included 403 men (73.6%) and 144 women (26.3%), with a mean age of 40.6 years. The main mechanism of trauma was falls (44.4%), followed by car accidents (24.5%). The most frequent pattern of injury was B2 injuries (46.6%), and the most affected level was T12-L1 (42.2%). Neurologic status at admission was 60.5% intact and 22.9% American Spinal Injury Association impairment scale A. The time from admission to surgery was >72 hours in over half the patients and over a week in >25% of them. The most commonly reported reasons for surgical delay were clinical instability (22.9%), lack of operating room availability (22.7%), and lack of hardware for spinal instrumentation (e.g., screws/rods) (18.8%). CONCLUSIONS: Timing for surgery in this sample of unstable fractures was over 72 hours in more than half of the sample and longer than a week in about a quarter. The main reasons for this delay were clinical instability and lack of economic resources. There is an apparent need for increased funding for the treatment of spinal trauma patients in Latin America.

Vertebroplasty and kyphoplasty in the USA from 2004 to 2017: national inpatient trends, regional variations, associated diagnoses, and outcomes.

BACKGROUND: To explore the national inpatient trends, regional variations, associated diagnoses, and outcomes of vertebral augmentation (vertebroplasty and kyphoplasty) in the USA from 2004 to 2017. METHODS: Data from the National Inpatient Sample were used to study hospitalization records for percutaneous vertebroplasty and kyphoplasty. Longitudinal projections of trends and outcomes, including mortality, post-procedural complications, length of stay, disposition, and total hospital charges were analyzed. RESULTS: Following a period of decreased utilization from 2008 to 2012, hospitalizations for vertebroplasty and kyphoplasty plateaued after 2013. Total hospital charges and overall financial burden of hospitalizations for vertebroplasty and kyphoplasty increased to a peak of $1.9 billion (range $1.7-$2.2 billion) in 2017. Overall, 8% of procedures were performed in patients with a history of malignancy. In multivariable modeling, lung cancer (adjusted OR (aOR) 2.6 (range 1.4-5.1)) and prostate cancer (aOR 3.4 (range 1.2-9.4)) were associated with a higher risk of mortality. The New England region had the lowest frequency of routine disposition (14.1±1.1%) and the lowest average hospital charges ($47 885±$1351). In contrast, 34.0±0.8% had routine disposition in the West Central South region, and average hospital charges were as high as $99 836±$2259 in the Pacific region. The Mountain region had the lowest number of procedures (5365±272) and the highest mortality rate (1.2±0.3%). CONCLUSION: National inpatient trends of vertebroplasty and kyphoplasty utilization remained stable after a period of decline from 2008 to 2012, while the financial burden of hospitalizations increased. Despite recent improvements in outcomes, significant regional variations persisted across the USA.

Cost-Benefit Analysis of Routine Bone Biopsy During Augmentation of Osteoporotic Vertebral Compression Fractures.

STUDY DESIGN: Multi-center prospective study. OBJECTIVE: To analyze the cost of routine biopsy during augmentation of osteoporotic vertebral compression fractures (VCF) and the affect it has on further treatment. SUMMARY OF BACKGROUND DATA: Vertebroplasty (VP) and Balloon Kyphoplasty (BKP) are accepted treatments for VCF. Bone biopsy is routinely performed during every VCF surgery in many centers around the world to exclude an incidental finding of malignancy as the cause of the pathological VCF. The incidence been reported as 0.7% to 7.3%, however the published cohorts are small and do not discuss cost-benefit aspects. METHODS: From 2008 to 2016 we performed 122 vertebral biopsies routinely on 116 patients in three hospitals. Twenty-three patients had history of malignancy (26 biopsies) and four were suspected of having malignancy based on imaging findings. The remaining 86 patients (99 biopsies) were presumed osteoporotic VCF. RESULTS: Out of 99 biopsies in the VCF cohort group only one yielded an unsuspected malignancy (1.16%), positive for multiple myeloma (MM). The ability of clinical assessment and imaging alone to diagnose malignancy was found to be 91.7% sensitive and 84.2% specific in our cohort. CONCLUSION: Routine bone biopsy during vertebral augmentation procedure is a safe option for evaluating the cause of the VCF but has significant cost to the health system. The cost of one diagnosed case of unsuspected malignancy was $31,000 in our study. The most common pathology was MM, which has not been proven to benefit from early diagnosis. When comparing clinical diagnosis with imaging, a previous history of malignancy was found in only 40.7% of VCF patients, while imaging was 100% accurate in predicting presence of malignancy on biopsy. This study reassures spine surgeons in their ability to diagnose malignant VCFs and does not support the significant cost of routine bone biopsies. LEVEL OF EVIDENCE: 3.

Comparison of Costs and Postoperative Outcomes between Vertebroplasty and Kyphoplasty for Osteoporotic Vertebral Compression Fractures: Analysis from a State-Level Outpatient Database.

BACKGROUND: Vertebral cement augmentation techniques are routinely used to treat osteoporotic vertebral compression fractures (VCFs). In the current study, we used a state-level outpatient database to compare costs and postoperative outcomes between vertebroplasty and kyphoplasty. METHODS: We queried the 2016 Florida State-Ambulatory Surgery Database of the Healthcare Cost and Utilization Project for patients undergoing thoracolumbar vertebroplasty or kyphoplasty for osteoporotic VCFs. Demographic and clinical characteristics, as well as postoperative outcomes were compared between the 2 groups. RESULTS: A total of 105 patients (11.6%) who underwent vertebroplasty and 801 patients (88.4%) who underwent kyphoplasty were identified. Patients undergoing kyphoplasty were more likely to stay overnight or longer, with the P value trending toward significance (kyphoplasty with >1 day stay: 7.4% vs. vertebroplasty with >1 day stay: 1.9%; P = 0.086). Patients undergoing vertebroplasty had a significantly higher rate of discharge to home routine compared with patients undergoing kyphoplasty (97.1% [n = 102] vs. 94.1% [n = 754]; P < 0.001). Undergoing kyphoplasty was also associated with higher index admission costs ($40,706 vs. $18,965; P < 0.001) and higher readmission costs ($27,038 vs. $11,341; P = 0.046). The rates of 30-day and 90-day readmission were similar between the 2 groups (all P > 0.05). The rates of 30-day, 90-day, and overall readmission because of a new-onset fracture were also similar (all P > 0.05). However, vertebroplasty had a higher rate of readmissions associated with a procedure within a year (21.9% [n = 23] vs. 14.5% [n = 116]; P = 0.047). CONCLUSIONS: Our analyses from a state-level database of patients undergoing vertebroplasty and kyphoplasty for osteoporotic VCFs show similar postoperative outcomes for the 2 procedures but a higher cost for kyphoplasty.

Do Medicare Accountable Care Organizations Reduce Disparities After Spinal Fracture?

BACKGROUND: National changes in health care disparities within the setting of trauma care have not been examined within Accountable Care Organizations (ACOs) or non-ACOs. We sought to examine the impact of ACOs on post-treatment outcomes (in-hospital mortality, 90-day complications, and readmissions), as well as surgical intervention among whites and nonwhites treated for spinal fractures. MATERIALS AND METHODS: We identified all beneficiaries treated for spinal fractures between 2009 and 2014 using national Medicare fee for service claims data. Claims were used to identify sociodemographic and clinical criteria, receipt of surgery and in-hospital mortality, 90-day complications, and readmissions. Multivariable logistic regression analysis accounting for all confounders was used to determine the effect of race/ethnicity on outcomes. Nonwhites were compared with whites treated in non-ACOs between 2009 and 2011 as the referent. RESULTS: We identified 245,704 patients who were treated for spinal fractures. Two percent of the cohort received care in an ACO, whereas 7% were nonwhite. We found that disparities in the use of surgical fixation for spinal fractures were present in non-ACOs over the period 2009-2014 but did not exist in the context of care provided through ACOs (odds ratio [OR] 0.75; 95% confidence interval [CI] 0.44, 1.28). A disparity in the development of complications existed for nonwhites in non-ACOs (OR 1.09; 95% CI 1.01, 1.17) that was not encountered among nonwhites receiving care in ACOs (OR 1.32; 95% CI 0.90, 1.95). An existing disparity in readmission rates for nonwhites in ACOs over 2009-2011 (OR 1.34; 95% CI 1.01, 1.80) was eliminated in the period 2012-2014 (OR 0.85; 95% CI 0.65, 1.09). CONCLUSIONS: Our work reinforces the idea that ACOs could improve health care disparities among nonwhites. There is also the potential that as ACOs become more familiar with care integration and streamlined delivery of services, further improvements in disparities could be realized.

Percutaneous Vertebroplasty: A History of Procedure, Technology, Culture, Specialty, and Economics.

Percutaneous vertebroplasty (VP) progressed from a virtually unknown procedure to one performed on hundreds of thousands of patients annually. The development of VP provides a historically exciting case study into a rapidly adopted procedure. VP was the synthesis of information gained from spinal biopsy developments, the inception of biomaterials used in medicine, and the unique health care climate in France during the 1980s. It was designed as a revolutionary technique to treat vertebral body fractures with minimal side effects and was rapidly adopted and marketed in the United States. The impact of percutaneous vertebroplasty on spine surgery was profound.

Analysis of Cervical Spine Injuries in Elderly Patients from 2001 to 2010 Using a Nationwide Database: Increasing Incidence, Overall Mortality, and Inpatient Hospital Charges.

BACKGROUND: Cervical spine (C-spine) injuries cause significant morbidity and mortality among elderly patients. Although the population of older-adults ≥65 years in the United States is expanding, estimates of the burden and outcome of C-spine injury are lacking. METHODS: The Nationwide Inpatient Sample 2001-2010 was analyzed. International Classification of Diseases, Ninth Revision, Clinical Modification codes identified patients with isolated C-spine fractures (ICF) and C-spine fractures with spinal cord injury (CSCI). Annual admission and mortality rates were calculated using U.S. Census data. RESULTS: A total of 167,278 older adults were included. Median age was 81 years (interquartile range = 74-86). Most patients were female (54.9%), had Medicare coverage (77.6%), were treated in teaching hospitals (63.2%), and had falls as the leading injury mechanism (51.2%). ICF occurred in 91.3%, whereas CSCI occurred in 8.7% (P < 0.001). ICF was more common in ≥85-year-old patients and CSCI in 65- to 69-year-old patients (P < 0.001). The most common injured C-spine level in ICF was the C2 level (47.6%, P < 0.001) and in CSCI was C1-C4 level (4.5%, P < 0.001). Overall, 15.8% underwent C-spine surgery. Hospitalization rates increased from 26/100,000 in 2001 to 68/100,000 in 2010 (∼167% change, P < 0.001). Correspondingly, overall mortality increased from 3/100,000 in 2001 to 6/100,000 in 2010, P < 0.001. In-hospital mortality was 11.3%, was strongly associated with increasing age and CSCI (P < 0.001). CONCLUSIONS: In summary, C-spine fractures among U.S. older adults constitute a significant health care burden. ICFs occur commonly, C2-vertebra fractures are most frequent, whereas CSCIs are linked to increased hospital-resource use and worse outcomes. The incidence of C-spine fractures and mortality more than doubled over the past decade; however, proportional in-hospital mortality is decreasing.

Short-Term Outcome in Subaxial Spine Injury Patients Operated on in a Resource-Limited Setting, Addis Ababa, Ethiopia.

BACKGROUND: Subaxial spinal injury surgery is expensive, and its significance is uncertain because of limited rehabilitation and postoperative care. OBJECTIVE: To assess complications and outcome in patients surgically treated for subaxial spinal injuries in 2 hospitals in Addis Ababa, Ethiopia. METHODS: Retrospective study, conducted among 85 patients operated on for subaxial spine injury from January 2013 to August 2016. Data were collected from medical charts. Descriptive statistics and binary logistic regression were used for data analysis. RESULTS: A total of 85 patients were included, and 20 patients were not followed up. The mean age was 33 years (standard deviation ± 12.03 years), and the mean time from injury to surgery was 10 days. The rates of surgical mortality and reoperation were 7.05% and 3.5%, respectively. Deaths occurred in 13 of 16 patients (81.1%) with American Spine Injury Association (ASIA) scores of A and in 3 of 16 patients (18.9%) with ASIA scores of B. The complication rate in patients with a preoperative ASIA score of A was 17/24 (70.8%). The study showed that 55 of 65 patients who were followed up (84.6%; 95% confidence interval [CI]: 75.4, 92.3) experienced improvement. According to the patients' follow-up ASIA scores, 47 (72.3%; 95% CI: 61.5, 83.1) were functional. Sphincter tone before operation (adjusted odds ratio 142.82; 95% CI: 9.973, 204.090) was significantly associated with follow-up ASIA score. CONCLUSIONS: Patients with complete cervical injuries had high rates of mortality and morbidity, indicating that it might be better not to operate on these patients in resource-limited settings. There is a moderate recovery rate in patients with incomplete SCI despite a lack of adequate rehabilitation facilities.

Post-operative bracing after pedicle screw fixation for thoracolumbar burst fractures: A cost-effectiveness study.

PURPOSE: While frequently prescribed to patients following fixation for spine trauma, the utility of spinal orthoses during the post-operative period is poorly described in the literature. In this study, we calculated rates of reoperation and performed a decision analysis to determine the utility of bracing following pedicle screw fixation for thoracic and lumbar burst fractures. METHODS: Pubmed was searched for articles published between 2005 and 2015 for terms related to pedicle screw fixation of thoracolumbar fractures. Additionally, a database of neurosurgical patients operated on within the authors institution was also used in the analysis. Incidences of significant adverse events (wound revision for either dehiscence or infection or re-operation for non-union or instability due to hardware failure) were determined. Pooled means and variances of reported parameters were obtained using a random-effects, inverse variance meta-analytic model for observational data. Utilities for surgical outcome and complications were assigned using previously published values. RESULTS: Of the 225 abstracts reviewed, 48 articles were included in the study, yielding a total of 1957 patients. After including patients from the institutional registry, together a total of 2081 patients were included in the final analysis, 1328 of whom were braced. Non-braced patients were older then braced patients, although this only approached significance (p=0.051). Braced patients had significantly lower rates of re-operation for non-union or clinically significant hardware failure (1.3% vs. 1.8%, p<0.001) although the groups had comparable rates of operative wound dehiscence and infection (p=1.000). These two approaches yielded comparable utility scores (p=0.120). Costs between braced and non-braced patients were comparable excluding the cost of the brace (p=0.256); hence, the added cost of the brace suggests that bracing post-operatively is not a cost effective measure. CONCLUSIONS: Bracing following operative stabilization of thoracolumbar fracture does not significantly improve stability, nor does it increase wound complications. Moreover, our data suggests that post-operative bracing may not be a cost-effective measure.

Inadvertently boarding a pirate ship: disease progression in a paediatric patient with relapsed metastatic Ewing sarcoma receiving treatment at a centre for alternative therapy in Mexico.

Complementary and alternative medicine (CAM) therapies are commonly incorporated into the care of patients with paediatric cancer. Many modalities are safe and effective during cancer treatment and have proved beneficial for symptom relief and quality of life. However, situations where alternative therapy is provided without allopathic medical care supportive care resources can pose a safety risk to patients. This report describes the case of a 16-year-old Chinese girl with metastatic Ewing sarcoma who sought treatment with alternative treatment in Mexico. When her disease progressed with an ensuing significant loss of function, the centre personnel were unable to respond to her acute deterioration or provide necessary medical care. This resulted in her being stranded in a foreign country paralysed, isolated, and with large unanticipated financial expenditures.

Health-care costs of conservative management of spine fractures in trauma patients.

BACKGROUND AND PURPOSE: There is a lack of evidence on the broad health-care costs of treating spine trauma patients without neurological deficits conservatively. The aim of the present study was to estimate the primary and secondary health-care sector costs associated with conservative treatment of spine fractures as well as their determinants. METHODS: Patients were identified between 1999 and 2008 in the hospital's administrative system based on relevant diagnostic codes. Inclusion criteria were: (1) spine fractures (C1-L5); (2) age >18; and (3) conservative treatment. Exclusion criteria were: (1) neurological involvement and (2) fractures secondary to osteoporosis/malignancy. Health-care utilization and costs were retrieved from national administrative databases covering the entire health-care sector. RESULTS: 201 cervical, 150 thoracic, and 140 lumbar fracture patients were included in the study. The total health cost was estimated at €18,919 (16,199; 21,756), €8571 (6062; 11,733), €5526 (3473; 7465) for cervical, thoracic, and lumbar regions, respectively. Hospital admissions accounted for the vast majority of costs while primary health care accounted for less than 3 % and prescription medication for less than 2 %. The determinants of costs included fracture site (p < 0.001) and concomitant lower limb injuries (p = 0.009). CONCLUSIONS: Spinal fractures, even mild ones, appear to incur substantial health-care utilization and costs. Health-care costs in conjunction with cervical fractures are more than two-fold of those affiliated with thoracic and lumbar fractures. Among the concomitant injuries, lower limb injuries exert a substantial influence over health-care costs.

Cost-Utility Analysis of Pedicle Screw Removal After Successful Posterior Instrumented Fusion in Thoracolumbar Burst Fractures.

STUDY DESIGN: A cost-utility analysis (CUA). OBJECTIVE: The aim of this study was to determine the cost-effectiveness of pedicle screw removal after posterior fusion in thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: Pedicle screw instrumentation is a standard fixation method for unstable thoracolumbar burst fracture. However, removal of the pedicle screw after successful fusion remains controversial because the clinical benefits remain unclear. CUA can help clinicians make appropriate decisions about optimal health care for pedicle screw removal after successful fusion in thoracolumbar burst fractures. METHODS: We conducted a single-center, retrospective, longitudinal matched-cohort study of prospectively collected outcomes. In total, 88 consecutive patients who had undergone pedicle screw instrumentation for thoracolumbar burst fracture with successful fusion confirmed by computed tomography (CT) were used in this study. In total, 45 patients wanted to undergo implant removal surgery (R group), and 43 decided not to remove the implant (NR group). A CUA was conducted from the health care perspective. The direct costs of health care were obtained from the medical bill of each patient. Changes in health-related quality of life (HRQoL) scores, validated by Short Form 6D, were used to calculate quality-adjusted life-years (QALYs). Total costs and gained QALY were calculated at 1 year (1 year) and 2 years (2 years) compared with baseline. Results are expressed as an incremental cost-effectiveness ratio (ICER). Different discount rates (0%, 3%, and 5%) were applied to both cost and QALY for sensitivity analysis. RESULTS: Baseline patient variables were similar between the two groups (all P > 0.05). The additional benefits of implant removal (0.201 QALY at 2 years) were achieved with additional costs ($2541 at 2 years), equating to an ICER of $12,641/QALY. On the basis of the different discount rates, the robustness of our study's results was also determined. CONCLUSION: Implant removal after successful fusion in a thoracolumbar burst fracture is cost-effective until postoperative year 2. LEVEL OF EVIDENCE: 3.

C2 Vertebral Fractures in the Medicare Population: Incidence, Outcomes, and Costs.

BACKGROUND: Cervical 2 (C2) fractures in the elderly are common, and the incidence of these fractures has been increasing. Surgical and nonoperative treatments are associated with high complication and mortality rates, and these rates have not been evaluated at the population level, to our knowledge. The purpose of this study was to use the Medicare claims database to determine trends in treatment, surgical and nonoperative outcomes, and Medicare reimbursement for treatment of these fractures. METHODS: We examined the Medicare claims database from 2000 to 2011 to identify patients admitted for the treatment of a C2 fracture. The incidence of fractures and the rates of nonoperative and surgical treatment were determined across the study period. We compared rates of mortality and life-threatening complications between patients treated nonoperatively and surgically. Centers for Medicare & Medicaid Services (CMS) payments for the initial admission as well as for subsequent inpatient admissions during the ninety-day post-admission period were compared between treatment groups. We used multivariate analysis to control for differences in patient characteristics between groups. RESULTS: There were 81,596 admissions for C2 fracture identified, and 53,338 met inclusion criteria. The incidence of C2 fractures increased 135% from 2000 to 2011, but the rate of surgical treatment remained constant at 16%. There was significantly lower mortality at thirty days for the surgical group at 8.3% compared with the nonoperative group at 16.2% (p < 0.001) and at one year for the surgical group at 21.7% compared with the nonoperative group at 32.3% (p < 0.001). Life-threatening complications within thirty days of admission were slightly more common in the surgical group at 10.9% compared with the nonoperative group at 9.0% (p < 0.05). Medicare reimbursements for the initial inpatient admission were significantly higher (p < 0.001) in U.S. dollars for the surgical group at $21,487 compared with the nonoperative group at $8469, and this significant difference (p < 0.001) persisted in the ninety-day post-discharge period at $10,487 for the surgical group compared with $8410 for the nonoperative group. CONCLUSIONS: Although the incidence of C2 fractures in the Medicare population increased from 2000 to 2011, the rate of surgery stayed relatively constant. After controlling for baseline differences, patients treated with surgery had significantly lower thirty-day and one-year mortality rates compared with patients treated nonoperatively. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cost Effectiveness of Operative Versus Non-Operative Treatment of Geriatric Type-II Odontoid Fracture.

STUDY DESIGN: Cost-effectiveness analysis. OBJECTIVE: To examine the cost-effectiveness of operative versus non-operative treatment of type-II odontoid fractures in patients older than 64 years old. SUMMARY OF BACKGROUND DATA: Significant controversy exists regarding the optimum treatment of geriatric patients with type-II odontoid fractures. Operative treatment leads to lower rates of non-union but carries surgical risks. Non-operative treatment does not carry surgical risks but has higher non-union rates. METHODS: A decision-analytic model was created to compare operative and non-operative treatment of type-II odontoid fractures among three age cohorts (65-74, 75-84, >84) based on expected costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs; cost per QALY gained). Age-specific mortality rates for both treatments, costs for treatment, and complication rates were taken from the literature, and data from 2010 US life tables were used for age-specific life expectancy. Costs of complications were estimated using data obtained at a level-I trauma center using micro-costing. Sensitivity analyses of all model parameters were conducted. RESULTS: Among the 65- to 74-year-old cohort, operative treatment was more costly ($53,407 vs. $30,553) and more effective (12.00 vs. 10.11 QALY), with an ICER of $12,078/QALY. Among the 75- to 84-year-old cohort, operative treatment was more costly ($51,308 vs. $29,789) and more effective (6.85 vs. 6.31 QALY), with an ICER of $40,467/QALY. Among the over-84 cohort, operative treatment was dominated by non-operative treatment as it was both more costly ($45,978 vs. $28,872) and less effective (2.48 vs. 3.73 QALY). The model was robust to sensitivity analysis across reasonable ranges for utility of union, disutility of complications and delayed surgery, and probabilities of non-union and complications. CONCLUSION: Operative treatment is cost-effective in patients age 65 to 84 when using $100,000/QALY as a benchmark but less effective and more costly than non-operative treatment in patients older than 84 years. LEVEL OF EVIDENCE: 2.

Cost-Effectiveness of Osteoporosis Screening Strategies for Men.

Osteoporosis affects many men, with significant morbidity and mortality. However, the best osteoporosis screening strategies for men are unknown. We developed an individual-level state-transition cost-effectiveness model with a lifetime time horizon to identify the cost-effectiveness of different osteoporosis screening strategies for US men involving various screening tests (dual-energy X-ray absorptiometry [DXA]; the Osteoporosis Self-Assessment Tool [OST]; or a fracture risk assessment strategy using age, femoral neck bone mineral density [BMD], and Vertebral Fracture Assessment [VFA]); screening initiation ages (50, 60, 70, or 80 years); and repeat screening intervals (5 years or 10 years). In base-case analysis, no screening was a less effective option than all other strategies evaluated; furthermore, no screening was more expensive than all strategies that involved screening with DXA or the OST risk assessment instrument, and thus no screening was "dominated" by screening with DXA or OST at all evaluated screening initiation ages and repeat screening intervals. Screening strategies that most frequently appeared as most cost-effective in base-case analyses and one-way sensitivity analyses when assuming willingness-to-pay of $50,000/quality-adjusted life-year (QALY) or $100,000/QALY included screening initiation at age 50 years with the fracture risk assessment strategy and repeat screening every 10 years; screening initiation at age 50 years with fracture risk assessment and repeat screening every 5 years; and screening initiation at age 50 years with DXA and repeat screening every 5 years. In conclusion, expansion of osteoporosis screening for US men to initiate routine screening at age 50 or 60 years would be expected to be effective and of good value for improving health outcomes. A fracture risk assessment strategy using variables of age, femoral neck BMD, and VFA is likely to be the most effective of the evaluated strategies within accepted cost-effectiveness parameters. DXA and OST are also reasonable screening options, albeit likely slightly less effective than the evaluated fracture risk assessment strategy. © 2016 American Society for Bone and Mineral Research.

Cost-Effectiveness of Surgical Versus Conservative Treatment for Thoracolumbar Burst Fractures.

STUDY DESIGN: Historical, register-based cohort study following 85 patients in the course of a time frame extending from 2 years before to 2 years after trauma occurrence. OBJECTIVE: To investigate the cost-effectiveness of surgery versus conservative management for thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: Despite the prevalence of thoracolumbar burst fractures, consensus has still not been reached in terms of their clinical management and whereas from a health policy point of view, efficient use of resources is equally important, literature pertaining to this aspect is limited. METHODS: Consecutive patients who were admitted to a university clinic between 2004 and 2008 because of CT-verified AO type A3 fractures (T11-L2), age 18 to 65 years Patients with neurological compromise, osteoporosis, or malignancy were not included. The cost parameter defined primary and secondary health-care use (2010 &OV0556;) and the effect parameter was based on three alternative measures of pain medication: morphine milligram and defined daily doses (DDD) of narcotic and nonnarcotic analgesics. For cost-effectiveness analysis, we employed a difference-in-difference approach, including control for treatment selection (age, sex, and fracture type). Nonparametric bootstrapping was used to estimate conventional 95% confidence intervals of mean estimates. RESULTS: When taking into consideration all health-care consumption, surgical management was observed to cost an additional &OV0556;10,734 (4215; 15,144) as compared with conservative management. The differences on morphine at 527(-3031; 6,016) milligram, narcotic analgesics at -8(-176; 127) DDD, and nonnarcotic analgesics at -3(-72; 58) DDD were all insignificant The probability for surgery being cost-effective did not exceed 50% for any value of willingness to pay for effect. CONCLUSION: Surgical management does not seem to be a cost-effective strategy as compared with conservative management for traumatic thoracolumbar burst fractures without neurological deficits. In addition, higher-volume studies examining the clinical effect of alternative management strategies would be valuable. LEVEL OF EVIDENCE: 3.

Nonoperative Management in Neurologically Intact Thoracolumbar Burst Fractures: Clinical and Radiographic Outcomes.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The identification of factors that lead to the failure of nonoperative management in neurologically intact thoracolumbar burst fractures. SUMMARY OF BACKGROUND DATA: The treatment of thoracolumbar burst fractures (TLBF) can be controversial, particularly in the neurologically intact. Surgery for intact burst fractures has been advocated for early mobilization and a shorter hospital stay. These goals, however, have not always been achieved, rejuvenating an interest in nonoperative treatment. METHODS: Sixty-eight neurologically intact patients with burst fractures of the thoracolumbar junction (T11-L2), and a thoracolumbar injury classification and severity score (TLICS) of 2, were treated at our institution. Based on CT scans, patients were scored based on the load-sharing classification (LSC) scale. Initial treatment consisted of bracing in clamshell thoracolumbar orthosis and gradual mobilization. RESULTS: Owing to pain limiting mobilization, 18 patients failed nonoperative management and required instrumentation. Those who failed nonsurgical management were significantly more kyphotic (8° ± 10) and stenotic (52% ± 14%) than those successfully treated nonoperatively (3° ± 7 and 63 ± 12%, respectively). The LSC score of those undergoing surgery (6.9 ± 1.1) was also greater than those successfully treated nonoperatively (5.8 ± 1.3, P = 0.006). Length of hospitalization was longer, and hospital charges higher in those requiring surgery compared to the nonoperative group. At follow-up there was no difference between groups in the visual analog score for pain (VAS) or the Oswestry disability index. CONCLUSION: Owing to pain limiting mobilization, a quarter of neurologically intact patients with thoracolumbar burst fractures and a TLICS score of 2 failed nonsurgical management. The greater the kyphosis, stenosis, and fragmentation of the fracture, the more likely patients required surgery. In addition to the TLICS classification, other radiographic and clinical parameters should be included in selecting appropriate treatment strategy. The cost savings with nonoperative treatment of intact burst fractures, when appropriate, are significant.

Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data.

BACKGROUND: Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed. OBJECTIVE: To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK. SETTING: A representative US hospital. STUDY DESIGN: Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs. METHODS: The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis. RESULTS: With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva System was attributable to 19 reduced adjacent-level fractures with the Kiva System. LIMITATIONS: This study does not compare the Kiva System with VP or any other non-surgical procedures for the treatment of VCF. CONCLUSION: This first-ever economic analysis of the KAST data showed that the Kiva System for vertebral augmentation is hospital resource and cost saving over BK in a hospital setting over 2 years. These savings are attributable to reduced risk of developing adjacent-level fractures with the Kiva System compared to BK.