Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Declining trend in osteoporosis management and screening following vertebral compression fractures - a national analysis of commercial insurance and medicare advantage beneficiaries.

BACKGROUND CONTEXT: Despite the increasing national incidence, osteoporosis and its associated comanagement, often remain an overlooked issue in the orthopedic world. Screening and associated management of osteoporosis is often only considered by providers when patients present with multiple fragility fractures. Current evidence with regard to the trends in screening and medical comanagement/antiosteoporotic therapy of osteoporotic vertebral compression fractures (VCFs) remains limited. PURPOSE: To understand trends, costs, and clinical impact associated the utilization of antiosteoporotic medication and screening with the 1 year following occurrences of sentinel/primary osteoporotic VCFs. STUDY DESIGN/SETTING: Retrospective review of 2008-2015Q3 Humana Administrative Claims (HAC) database. PATIENT SAMPLE: The 2008-2015Q3 HAC database was queried using International Classification of Diseases 9th Edition (ICD-9) diagnosis codes 805.2 and 805.4 to identify patients with primary closed osteoporotic thoracolumbar VCFs. Patients with a concurrent diagnosis of trauma and/or malignancy were excluded. Patients experiencing a fragility fracture of the hip, distal radius or proximal humerus, and/or those already on osteoporotic medications within the year before the VCF were excluded to prevent an overlap in the screening and/or antiresorptive medication rates. Finally, only those patients who had complete 2-year follow-up data were analyzed. OUTCOME MEASURES: To understand trends over time in the utilization of medication for osteoporosis and screening within 1 year following sentinel VCFs. The study also aimed to report per-prescription and per-patient average costs associated with different antiosteoporotic medications. As secondary objectives, we also assessed (1) risk factors associated with not receiving antiosteoporotic medication within the year following sentinel VCFs and (2) differences in rates of experiencing a secondary fragility fracture of vertebrae, hip, distal radius, and proximal humerus between patients who received medication following the sentinel VCF versus those who did not receive any medication. RESULTS: A total of 6,464 primary osteoporotic VCFs were retrieved from the database. A majority of the VCFs were seen in females (N=5,199; 80.4%). Only 28.8% (N=1,860) patients received some form of medication for osteoporosis medication in the year following the VCF. Over a 6-year interval, treatment with medication for osteoporosis declined from 38% in 2008 to 24% in 2014. The average cost of antiosteoporotic treatment per patient was $1,511. The most commonly prescribed treatment and associated average cost/patient was alendronate sodium (N=1,239; 66.6% to $120/patient). The most costly prescribed treatment was Forteo (N=177; 2.7%) with an average cost/patient of $12,074 and cost/injection being $2,373. Only 36.7% (N=2,371) received a dual-energy X-ray absorptiometry/bone density scan in the year following the VCF with an average cost/patient of $76. Risk factors associated with no prescription of medication for osteoporosis within 1 year of VCF were male gender (odds ratio [OR] 1.17 [95% confidence interval {CI} 1.01-1.35]; p=.027), history of cerebrovascular accident/stroke (OR 1.56 [95% CI 1.08-2.32]; p=.022), history of diabetes mellitus (OR 1.28 [95% CI 1.04-1.58]; p=.023). Of note, patients in the West versus Midwest (OR 1.26 [95% CI 1.04-1.51]; p=.016) and commercial insurance beneficiaries (OR 1.95 [95% CI 1.08-3.52]; p=.027) were more likely to receive antiosteoporotic medication. Patients who were placed on antiosteoporotic medication were significantly less likely to suffer a second fragility fracture compared with patients that did not receive medication (OR 0.27 [95% CI 0.24-0.31]; p=.033). CONCLUSIONS: The proportion of patients starting antiosteoporotic medication within a year after a VCF remains low (28.8%). Furthermore, a declining trend of antiosteoporotic medication prescription was noted over time. Providers who care for patients with sentinel VCFs need to be more diligent in their efforts to diagnose and treat the underlying osteoporosis to reduce the burden of future fragility fractures.

Medial Branch Block Versus Vertebroplasty for 1-Level Osteoporotic Vertebral Compression Fracture: 2-Year Retrospective Study.

OBJECTIVE: Percutaneous vertebroplasty (VP) and medial branch block (MBB) are used to treat osteoporotic vertebral compression fractures (VCF). We compared the clinical outcomes, radiologic changes, and economic results of MBB with those of VP in treating osteoporotic VCFs. METHODS: A total of 164 patients with 1-level osteoporotic VCF were reviewed retrospectively. The clinical outcomes were measured with a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). To compare economic costs between groups, total hospital costs at the last follow-up day were calculated. RESULTS: The patients were divided into 2 groups: 72 patients in the conservative group treated by MBB (MBB group) and 92 patients in the group who underwent VP (VP group). The VAS and ODI scores improved significantly within postoperative week 1 in the VP group compared with the MBB group. However, the VAS and ODI scores did not differ between the groups after 1 postoperative year. After 2 years of follow-up, 14 new fractures occurred in the VP group and 3 in the MBB group. The improvement in compression ratio was statistically greater in the VP group than in the MBB group. However, after 2 years the radiologic changes between groups did not differ statistically. After the final follow-up visits, the hospital costs were significantly lower in the MBB group. CONCLUSIONS: After 2 years of follow-up, VP and MBB both had similar efficacy in terms of pain relief and radiologic changes. MBB was more cost effective than VP. Thus, MBB alone can be a possible alternative to VP in patients with 1-level osteoporotic VCFs.

The analysis of MSTMOVCF (Multi-segment thoracolumbar mild osteoporotic fractures surgery or conservative treatment) based on ASTLOF (the assessment system of thoracolumbar osteoporotic fracture).

To investigate the issue that conservative or surgical treatment for multi-segmental thoracolumbar mild osteoporotic vertebral compression fracture (MSTMOVCF) by applying the assessment system of thoracolumbar osteoporotic fracture (ASTLOF). A single-center prospective cohort study was designed to enroll elderly patients with MSTMOVCF from June 2013 to June 2016, which were divided into conservative and surgery group. The primary outcomes were Visual Analogue Scale (VAS) score and Oswestry Disability Index (ODI) score, with secondary outcomes including SF-36 and imaging measures such as height of anterior and middle column, Beck value, complications. A total of 470 patients with MSTMOVCF were enrolled. 193 patients underwent surgery of percutaneous vertebroplasty (PVP) or percutaneous kyphoplasty (PKP) and 277 patients underwent conservative treatment. The VAS score of operation group was significantly lower than that of conservative group (P < 0.0001, for all). The ODI score of the operation group was significantly lower than that of conservative group (P < 0.0001, for all). The SF-36 score, height of anterior and middle column, Beck value in the operation group were higher than those in conservative group (P < 0.0001, for all) at 1-year follow-up. MSTMOVCF underwent surgery can achieve great short-term clinical results. The patient with the sum of revised ASTLOF scores of multiple injured vertebrae ≥ 5 was recommended for surgery.

Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: An Economic Analysis.

BACKGROUND: Untreated vertebral compression fractures can have serious clinical consequences and impose a considerable impact on patients' quality of life and on caregivers. Since non-surgical management of these fractures has limited effectiveness, vertebral augmentation procedures are gaining acceptance in clinical practice for pain control and fracture stabilization. The objective of this analysis was to determine the cost-effectiveness and budgetary impact of kyphoplasty or vertebroplasty compared with non-surgical management for the treatment of vertebral compression fractures in patients with cancer. METHODS: We performed a systematic review of health economic studies to identify relevant studies that compare the cost-effectiveness of kyphoplasty or vertebroplasty with non-surgical management for the treatment of vertebral compression fractures in adults with cancer. We also performed a primary cost-effectiveness analysis to assess the clinical benefits and costs of kyphoplasty or vertebroplasty compared with non-surgical management in the same population. We developed a Markov model to forecast benefits and harms of treatments, and corresponding quality-adjusted life years and costs. Clinical data and utility data were derived from published sources, while costing data were derived using Ontario administrative sources. We performed sensitivity analyses to examine the robustness of the results. In addition, a 1-year budget impact analysis was performed using data from Ontario administrative sources. Two scenarios were explored: (a) an increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario, maintaining the current proportion of kyphoplasty versus vertebroplasty; and (b) no increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario but an increase in the proportion of kyphoplasties versus vertebroplasties. RESULTS: The base case considered each of kyphoplasty and vertebroplasty versus non-surgical management. Kyphoplasty and vertebroplasty were associated with an incremental cost-effectiveness ratio of $33,471 and $17,870, respectively, per quality-adjusted life-year gained. The budgetary impact of funding vertebral augmentation procedures for the treatment of vertebral compression fractures in adults with cancer in Ontario was estimated at about $2.5 million in fiscal year 2014/15. More widespread use of vertebral augmentation procedures raised total expenditures under a number of scenarios, with costs increasing by $67,302 to $913,386. CONCLUSIONS: Our findings suggest that the use of kyphoplasty or vertebroplasty in the management of vertebral compression fractures in patients with cancer may be a cost-effective strategy at commonly accepted willingness-to-pay thresholds. Nonetheless, more widespread use of kyphoplasty (and vertebroplasty to a lesser extent) would likely be associated with net increases in health care costs.

[The cost effectiveness analysis of minimally invasive surgery and conservative treatment in elderly osteoporotic spinal fracture].

OBJECTIVE: To evaluate the cost effectiveness of conservative treatment, percutaneous vertebroplasty(PVP)and percutaneous kyphoplasty(PKP)for elderly osteoporotic vertebral compression fracture(OVCF). METHODS: The clinical data of 152 patients with osteoporotic vertebral compression fractures, collected in the orthopedic department of 309th Hospital of PLA from October 2013 to July 2014, was retrospectively analyzed. According to the therapeutic methods, the patients who met the inclusion criteria were divided into conservative treatment group (51 cases), percutaneous vertebroplasty group (50 cases) and percutaneous kyphoplasty group(51 cases). The average medical cost (C) in hospital period and 1 year after discharging, and the treatment effect (E) according to standard of "cure" (VAS score less than or equal to 2) or "improvement" (VAS score was 3 to 8) was recorded. Then the C/E value indicated the cost effectiveness in different standards. RESULTS: The average hospitalization days of the PVP and PKP group was 3 to 5 days with an average of(3.4±0.6) days. The conservative group was 12 to 15 days with an average of (14.0±0.6) days. During the hospitalization period, the cost effectiveness of the conservative group, PVP group and PKP group were RMB 1 253.88, 935.75, 983.99 yuan, respectively, according to the standard of "cure". The PVP group was superior to the PKP group and the latter was superior to the conservative group. If "improvement" was used as the standard of evaluation, the results were RMB 97.80, 449.16, 501.84 yuan, respectively, suggesting that the conservative group was better than the PVP group and the latter was better than the PKP group. After hospital discharge, the cost effectiveness of the conservative group, PVP group and PKP group were RMB 3 834.05, 1 878.41 and 1 916.11 yuan, respectively, according to the standard of "cure". The PVP group was superior to the PKP group and the latter exceeded the conservative group. CONCLUSIONS: The study showed that the PVP was the best choice at the evaluation criterion of "cure", while taking "improvement" as the evaluation criterion, the conservative treatment was the best one. Either way, the PVP was the best choice after hospital discharge.

An assessment system for evaluating the severity of thoracolumbar osteoporotic fracture and its clinical application: A retrospective study of 381 cases.

OBJECTIVE: We put forward an assessment system of thoracolumbar osteoporotic fracture (ASTLOF) evaluating the severity of thoracolumbar osteoporotic fracture. This study was to investigate its efficacy in guiding clinical practice. METHODS: Three hundred and eighty-one patients with thoracolumbar vertebral osteoporosis fracture admitted to the hospital from January 2010 to December 2011 were enrolled in the study. All cases were evaluated by ASTLOF including evaluation of morphological changes, MRI, bone mineral density and pain. The patients were treated with different methods according to ASTLOF score. All patients were followed up on a regular basis. The treatment results were assessed by VAS and ODI. RESULTS: All patients were followed up with an average of 20.1 (range: 6-30) months. There were 91 cases of ASTLOF score<4 points. Their average VAS score decreased from 8.0 ± 1.7 points to 2.0 ± 1.3 with statistical significance (P<0.05) and the average ODI score decreased from 69.5 ± 2.8 to 38.1 ± 1.5 (P<0.05). One hundred and thirty-two cases were with ASTLOF score=4, with the average VAS score decreased from 8.2 ± 1.4 to 1.9 ± 1.2 (P<0.05) and the average ODI score decreased from 71.5 ± 3.7 to 36.2 ± 2.5 (P<0.05). There were 158 cases of ASTLOF score ≥ 5, with the VAS score decreased from 8.0 ± 1.7 to 2.0 ± 1.3 and the ODI score decreased from 69.5 ± 2.8 to 38.1 ± 1.5. CONCLUSIONS: ASTLOF based on the severity of thoracolumbar osteoporotic fracture was suggested to be helpful in guiding clinical practice.

Management of the Elderly With Vertebral Compression Fractures.

Vertebral compression fractures (VCFs) are the most common type of fracture secondary to osteoporosis. These fractures are associated with significant rates of morbidity and mortality and annual direct medical expenditures of more than $1 billion in the United States. Although many patients will respond favorably to nonsurgical care of their VCF, contemporary natural history data suggest that more than 40% of patients may fail to achieve significant pain relief within 12 months of symptom onset. As a result, percutaneous vertebral augmentation is often used to hasten symptom resolution and return of function. However, controversy regarding the role of kyphoplasty and vertebroplasty in the treatment of symptomatic VCFs exists. The purposes of this review are (1) to outline the epidemiology of VCFs as well as the physical morbidity and economic impact of these injuries, (2) to familiarize the reader with the best available evidence surrounding the operative and nonoperative treatment of VCFs, and (3) to examine the literature pertaining to the cost-effectiveness of surgical management of VCFs with the overarching goal of helping physicians make informed decisions regarding symptomatic VCF treatment.

Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population.

STUDY DESIGN: Vertebral compression fracture (VCF) patients in the 100% US Medicare data set (2005-2009). OBJECTIVE: To compare the mortality and morbidity risks for VCF patients undergoing conservative treatment (nonoperated), balloon kyphoplasty (BKP), and vertebroplasty (VP). SUMMARY OF BACKGROUND DATA: Studies have reported lower mortality risk for BKP or VP cohorts than nonoperated cohorts, but it is uncertain whether there are any differences in morbidity risks. METHODS: Survival and morbidity was estimated by the Kaplan-Meier method, and the differences in outcomes were assessed by Cox regression between BKP, VP, and nonoperated cohorts. A propensity matching analysis was used to account for potential bias. RESULTS: A total of 1,038,956 VCF patients were identified, including 141,343 BKP patients and 75,364 VP patients. The nonoperated cohort was found to have a 55% higher adjusted risk of mortality (P < 0.001) than the BKP cohort and 25% higher adjusted risk of mortality (P < 0.001) than the VP cohort. The BKP cohort was also found to have a 19% lower adjusted risk of mortality (P < 0.001) than the VP cohort. The findings were similar for mortality with pneumonia diagnosed in the 90 days before death and also after propensity matching, as well as for subgroups of osteoporotic VCF patients, including those who survived at least 1 year and those with no cancer diagnosis. With propensity matching, the nonoperated cohort had significantly higher adjusted risks of pneumonia, myocardial infarction/cardiac complications, DVT, and urinary tract infection than the BKP cohort but lower adjusted risks of subsequent augmentation/fusion, subsequent augmentation, and pulmonary/respiratory complications. The BKP cohort also had significantly lower risks of morbidity than the VP cohort, except for deep venous thrombosis (DVT), infection, and myocardial infarction/cardiac complications, which were similar between both cohorts. CONCLUSION: VCF patients in the Medicare population who received vertebral augmentation therapies, specifically BKP and VP, experienced lower mortality and overall morbidity than VCF patients who received conservative management. LEVEL OF EVIDENCE: 3.

One-year disease-related health care costs of incident vertebral fractures in osteoporotic patients.

SUMMARY: The study aims to estimate the direct disease-related costs of osteoporotic vertebral compression fractures (OVCF) in patients with newly diagnosed fracture in the first year after index in Germany. Analyses reveal that OVCFs are associated with significant costs. In light of high and increasing incidence, the results emphasize importance of research in this field. INTRODUCTION: OVCF are among the most common fractures related to osteoporosis. They have been shown to be associated with excess mortality and meaningful healthcare costs. Costs calculations have illustrated the significant financial burden to society and national social security systems. However, this information is not available for Germany. Therefore, aim of the study was to estimate the direct disease-related costs of OVCF in patients with newly diagnosed fracture in the first year after index in Germany. METHODS: Data were obtained from a claims dataset of a large German health insurance fund. Subjects ≥ 60 years with a new vertebral fracture between 2006 and 2010 were studied retrospectively compared to a matched paired OVCF-free patient group. All-cause and fracture-specific medical costs were calculated in the 1-year baseline and follow-up period. Generalized linear model (GLM) was estimated for total follow-up healthcare cost. RESULTS: A total of 2,277 pairs of matched OVCF and OVCF-free patients were included in the analysis. Baseline costs were higher in the OVCF group. Mean unadjusted all-cause healthcare cost difference in the four quarters following the index date between OVCF and OVCF-free patients was 8,200 (p < 0.001). Of the difference, almost two third was attributable to inpatient services and one quarter to prescription drug costs. The GLM procedure revealed that OVCF-related costs in the first year after the index date add up to 6,490 (p < 0.001; CI 5,809 -6,731 ). CONCLUSIONS: Despite limitations of this study, our results are consistent with other research and demonstrate that OVCFs are associated with significant costs. The results underline the importance of medical interventions that can help to prevent fractures and treatments, which are cost-effective and can prevent recurrent fractures.

Impact of nonoperative treatment, vertebroplasty, and kyphoplasty on survival and morbidity after vertebral compression fracture in the medicare population.

BACKGROUND: The treatment of vertebral compression fractures with vertebral augmentation procedures is associated with acute pain relief and improved mobility, but direct comparisons of treatments are limited. Our goal was to compare the survival rates, complications, lengths of hospital stay, hospital charges, discharge locations, readmissions, and repeat procedures for Medicare patients with new vertebral compression fractures that had been acutely treated with vertebroplasty, kyphoplasty, or nonoperative modalities. METHODS: The 2006 Medicare Provider Analysis and Review File database was used to identify 72,693 patients with a vertebral compression fracture. Patients with a previous vertebral compression fracture, those who had had a vertebral augmentation procedure in the previous year, those with a diagnosis of malignant neoplasm, and those who had died were excluded, leaving 68,752 patients. The patients were stratified into nonoperative treatment (55.6%), vertebroplasty (11.2%), and kyphoplasty (33.2%) cohorts. Survival rates were compared with use of Kaplan-Meier analysis and Cox regression. Results were adjusted for potential confounding variables. Secondary parameters of interest were analyzed with the chi-square test (categorical variables) and one-way analysis of variance (continuous variables), with the level of significance set at p < 0.05. RESULTS: The estimated three-year survival rates were 42.3%, 49.7%, and 59.9% for the nonoperative treatment, vertebroplasty, and kyphoplasty groups, respectively. The adjusted risk of death was 20.0% lower for the kyphoplasty group than for the vertebroplasty group (hazard ratio = 0.80, 95% confidence interval, 0.77 to 0.84). Patients in the kyphoplasty group had the shortest hospital stay and the highest hospital charges and were the least likely to have had pneumonia and decubitus ulcers during the index hospitalization and at six months postoperatively. However, kyphoplasty was more likely to result in a subsequent augmentation procedure than was vertebroplasty (9.41% compared with 7.89%; p < 0.001). CONCLUSIONS: Vertebral augmentation procedures appear to be associated with longer patient survival than nonoperative treatment does. Kyphoplasty tends to have a more striking association with survival than vertebroplasty does, but it is costly and may have a higher rate of subsequent vertebral compression fracture. These provocative findings may reflect selection bias and should be addressed in a prospective, direct comparison of methods to treat vertebral compression fractures. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Balloon kyphoplasty compared to vertebroplasty and nonsurgical management in patients hospitalised with acute osteoporotic vertebral compression fracture: a UK cost-effectiveness analysis.

UNLABELLED: The purpose of the study was to estimate the cost-effectiveness of balloon kyphoplasty compared to nonsurgical management and vertebroplasty for the treatment of hospitalised osteoporotic vertebral compression fractures in the UK. A cost-effectiveness model was constructed and used for analysis. Balloon kyphoplasty may be cost-effective compared to relevant alternatives. INTRODUCTION: The objective of this study was to estimate the cost-effectiveness of balloon kyphoplasty (BKP) for the treatment of patients hospitalised with acute osteoporotic vertebral compression fracture (OVCF) compared to percutaneous vertebroplasty (PVP) and nonsurgical management (NSM) in the UK. METHODS: A Markov simulation model was developed to evaluate treatment with BKP, NSM and PVP in patients with symptomatic OVCF. Data on health-related quality of life (HRQoL) with acute OVCF were derived from the FREE and VERTOS II randomised clinical trials (RCTs) and normalised to the NSM arm in the FREE trial. Estimated differences in mortality among the treatments and costs for NSM were obtained from the literature whereas procedure costs for BKP and PVP were obtained from three National Health Service hospitals. It was assumed that BKP and PVP reduced hospital length of stay by 6 days compared to NSM. RESULTS: The incremental cost-effectiveness ratio was estimated at Great Britain Pound Sterling (GBP) 2,706 per quality-adjusted life year (QALY) and GBP 15,982 per QALY compared to NSM and PVP, respectively. Sensitivity analysis showed that the cost-effectiveness of BKP vs. NSM was robust when mortality and HRQoL benefits with BKP were varied. The cost-effectiveness of BKP compared to PVP was particularly sensitive to changes in the mortality benefit. CONCLUSION: BKP may be a cost-effective strategy for the treatment of patients hospitalised with acute OVCF in the UK compared to NSM and PVP. Additional RCT data on the benefits of BKP and PVP compared to simulated sham surgery and further data on the mortality benefits with BKP compared to NSM and PVP would reduce uncertainty.

Cost-effectiveness analysis of treatments for vertebral compression fractures.

BACKGROUND: Vertebral compression fractures (VCFs) can be treated by nonsurgical management or by minimally invasive surgical treatment including vertebroplasty and balloon kyphoplasty. OBJECTIVE: The purpose of the present study was to characterize the cost to Medicare for treating VCF-diagnosed patients by nonsurgical management, vertebroplasty, or kyphoplasty. We hypothesized that surgical treatments for VCFs using vertebroplasty or kyphoplasty would be a cost-effective alternative to nonsurgical management for the Medicare patient population. METHODS: Cost per life-year gained for VCF patients in the US Medicare population was compared between operated (kyphoplasty and vertebroplasty) and non-operated patients and between kyphoplasty and vertebroplasty patients, all as a function of patient age and gender. Life expectancy was estimated using a parametric Weibull survival model (adjusted for comorbidities) for 858 978 VCF patients in the 100% Medicare dataset (2005-2008). Median payer costs were identified for each treatment group for up to 3 years following VCF diagnosis, based on 67 018 VCF patients in the 5% Medicare dataset (2005-2008). A discount rate of 3% was used for the base case in the cost-effectiveness analysis, with 0% and 5% discount rates used in sensitivity analyses. RESULTS: After accounting for the differences in median costs and using a discount rate of 3%, the cost per life-year gained for kyphoplasty and vertebroplasty patients ranged from $US1863 to $US6687 and from $US2452 to $US13 543, respectively, compared with non-operated patients. The cost per life-year gained for kyphoplasty compared with vertebroplasty ranged from -$US4878 (cost saving) to $US2763. CONCLUSIONS: Among patients for whom surgical treatment was indicated, kyphoplasty was found to be cost effective, and perhaps even cost saving, compared with vertebroplasty. Even for the oldest patients (85 years of age and older), both interventions would be considered cost effective in terms of cost per life-year gained.

A review of vertebroplasty for osteoporotic and malignant vertebral compression fractures.

Vertebral compression fractures are a common clinical problem and the incidence of them will increase with the ageing population. Traditionally management has been conservative; however, there has been a growing trend towards vertebroplasty as an alternative therapy in patients with persisting severe pain. NICE produced guidance in 2003 recommending the procedure after 4 weeks of conservative management. Recent high-quality studies have been contradictory and there is currently a debate surrounding the role of the procedure with no agreement in the literature. We examine the evidence in both osteoporotic and malignant vertebral compression fractures; we also describe the benefits and side effects, alternative treatment options and the cost of the procedure. Finally, we recommend when vertebroplasty is most appropriately used based on the best available evidence.

Osteoporotic vertebral compression fractures: surgery versus non-operative management.

This 12-month retrospective study compared pain relief, quality of life (QoL), treatment cost-effectiveness and complication rates in patients with acute osteoporotic vertebral compression fracture (OVCF) undergoing percutaneous vertebroplasty (PVP; n = 58), percutaneous kyphoplasty (PKP; n = 55), or conservative medical therapy (CMT; n = 55). After surgery, Cobb angle and vertebral height were significantly improved in the PKP group. PVP and PKP patients had significantly less pain immediately after surgery than CMT patients, but this difference disappeared between weeks 2-8, only to return from months 6-12. QoL was significantly better among the surgical groups after surgery and was lower in the CMT group than in the surgical groups. Treatment times were shorter with PVP and PKP, but costs were lower with CMT. The rate of secondary fractures during follow-up was greater with CMT. Overall, PVP was considered the first choice treatment for OVCF with refractory pain.

Comparison of inpatient treatment costs after balloon kyphoplasty and non-surgical treatment of vertebral body compression fractures.

We performed an analysis of following costs after primary conservative or operative treatment with balloon kyphoplasty (BKP) in osteoporotic vertebral fractures. Patients with primary osteoporotic vertebral fractures treated with BKP or conservatively from discharge year 2002-2005 were retrospectively assessed regarding the following hospital treatment in any hospital in Austria from 2002 to 2006. A statistical record linkage between the hospital data and the mortality registry of Statistic Austria was performed. The data search was restricted to ICD-10 and procedures according to the Austrian catalogue of procedures defined as "spine relevant". Number of readmissions, length of hospital stay and DRG related costs were calculated for the surgical and conservative group separately. 324.5 years (mean 2.93 ± 1.40, conservative group) and 343.6 (mean 2.56 ± 0.96, BKP group) of 110 conservative patients and 134 BKP patients were analyzed. There was no statistical difference of the mortality rate with 9 patients (6.7%, BKP) and 11 patients (9.9%, conservative). The number of readmissions was 1.62 times higher (P = 0.039), the length of stay 1.09 times higher (P = 0.046) in the conservative group. No difference in the DRG scores were found (P = 0.11). In conclusion, patients with osteoporotic vertebral fractures showed in the following years after BKP fewer hospital readmissions and shorter hospital stays but no difference in DRG scores in comparison to conservatively treated patients.

Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial.

BACKGROUND: Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. METHODS: Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. FINDINGS: Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was -5·2 (95% CI -5·88 to -4·72) after vertebroplasty and -2·7 (-3·22 to -1·98) after conservative treatment, and between baseline and 1 year was -5·7 (-6·22 to -4·98) after vertebroplasty and -3·7 (-4·35 to -3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74-3·37, p<0·0001) at 1 month and 2·0 (1·13-2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. INTERPRETATION: In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. FUNDING: ZonMw; COOK Medical.

Monoclonal gammopathy of undetermined significance: why identification of these patients and assessment of their skeletons is important.

Monoclonal gammopathy of undetermined significance (MGUS) is a plasma cell disorder characterized by the presence of a serum monoclonal immunoglobulin (M-protein) at