Utilization of Vertebral Augmentation Procedures in the USA: a Comparative Analysis in Medicare Fee-for-Service Population Pre- and Post-2009 Trials.

PURPOSE OF REVIEW: To review the utilization patterns of vertebral augmentation procedures in the US Medicare population from 2004 to 2017 surrounding concurrent developments in the literature and the enactment of the Affordable Care Act (ACA). RECENT FINDINGS: The analysis of vertebroplasty and kyphoplasty utilization patterns was carried out using specialty utilization data from the Centers for Medicare and Medicaid Services Database. Of note, over the period of time between 2009 and 2017, the number of people aged 65 or older showed a 3.2% rate of annual increase, and the number of Medicare beneficiaries increased by 27.6% with a 3.1% rate of annual increase. Concurrently, vertebroplasty utilization decreased 72.8% (annual decline of 15% per 100,000 Medicare beneficiaries), and balloon kyphoplasty utilization decreased 19% (annual decline of 2.6% per 100,000 Medicare beneficiaries). This translates to a 38.3% decrease in vertebroplasty and balloon kyphoplasty utilization (annual decline of 5.9% per 100,000 Medicare beneficiaries) from 2009 to 2017. By contrast, from 2004 to 2009, there was a total 188% increase in vertebroplasty and balloon kyphoplasty utilization (annual increase rate of 23.6% per 100,000 Medicare beneficiaries). The majority of vertebroplasty procedures were done by radiologists, and the majority of kyphoplasties were done by aggregate groups of spine surgeons. These results illustrate a significant decline in vertebral augmentation procedures in the fee-for-service Medicare population between 2004 and 2017, with dramatic decreases following the publication of two 2009 trials that failed to demonstrate benefit of vertebroplasty over sham and the enactment of the ACA.

Medicare Accountable Care Organizations and Use of Potentially Low-Value Procedures.

OBJECTIVE: To evaluate the effect of Accountable Care Organizations (ACOs) on the use of vertebroplasty and arthroscopic partial meniscectomy, 2 procedures for which randomized controlled trials suggest similar outcomes to sham surgery and therefore may provide low value. Medicare Shared Savings Program ACOs aim to improve quality and decrease health care spending. Reducing the use of potentially low-value procedures can accomplish both of these goals. METHODS: We performed a retrospective cohort study of patients who underwent potentially low-value orthopedic procedures (vertebroplasty and partial meniscectomy) and a control (hip fracture) from 2010 to 2015 using a 20% sample of national Medicare claims. We performed an interrupted time-series analysis using linear spline models to evaluate the count of each procedure per 1000 patients, stratified by ACO participation. RESULTS: We identified 76 256 patients who underwent arthroscopic partial meniscectomy, 44 539 patients who underwent vertebroplasty, and 50 760 patients who underwent hip fracture admission. Arthroscopic partial meniscectomy rates decreased, vertebroplasty rates remained stable, and hip fracture rates increased for both groups during the study period, with similar trends among ACO and non-ACO patients. After January 1, 2013, ACO and non-ACO populations had similar trends for vertebroplasty (ACO incidence rate ratio [IRR] = 1.15 [1.08-1.23] vs non-ACO IRR = 1.11 [1.05-1.16]), meniscectomy (ACO IRR = 1.06 [1.01-1.12] vs non-ACO IRR = 1.03 [0.99-1.07]), and hip fracture (ACO IRR = 1.08 [1.01-1.14] vs non-ACO IRR = 1.08 [1.03-1.13]). CONCLUSIONS: ACOs were not associated with a reduction in the frequency of vertebroplasty and arthroscopic partial meniscectomy.

Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials?

The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients. INTRODUCTION: BKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients. METHODS: BKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors. RESULTS: The cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort. CONCLUSIONS: Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

Clinical outcome and subsequent sequelae of cement extravasation after percutaneous kyphoplasty and vertebroplasty: a comparative review.

Background Injection of cement during vertebroplasty and kyphoplasty can leak into surrounding structures and could be symptomatic. Purpose To identify the sites and incidence of cement extravasation after kyphoplasty and vertebroplasty, and to evaluate their impacts on clinical outcomes. Material and Methods A retrospective review of 316 patients treated with kyphoplasty and vertebroplasty; 411 cases were included (223 kyphoplasty and 188 vertebroplasty). Cement extravasation was evaluated postoperatively by computed tomography (CT) scan of the spine. Clinical outcomes were assessed by visual analog scale (VAS) and Oswestry Disability Index (ODI). Results There was a statistically significant difference in the incidence rate of cement extravasation between vertebroplasty and kyphoplasty groups ( P < 0.04). The most common site of cement extravasation was in paravertebral soft tissues for vertebroplasty (n = 33, 40.7%) and for kyphoplasty (n = 30, 30%). In the subgroup where cement leaked into the intradiscal space, adjacent vertebral body fractures occurred in 3/26 vertebrae (11.5%) in the vertebroplasty group and in 2/18 vertebrae (11.1%) in the kyphoplasty group. Both groups showed a statistically significant decrease in both VAS ( P < 0.001) and ODI scores ( P < 0.001). There was no significantly difference in patient satisfaction between those who had cement extravasation and those who did not, in both groups. Conclusion Kyphoplasty has an advantage in terms of less risk of cement extravasation. However, this factor did not reflect on subsequent sequelae or final clinical outcomes. This study did not find a distinct correlation between intradiscal cement extravasation and increased risk of adjacent vertebral fractures.

Osteoporotic thoracolumbar compression fractures: long-term retrospective comparison between vertebroplasty and conservative treatment.

PURPOSE: To compare long term clinical and radiographic outcomes in osteoporotic vertebral compression fractures of the thoracolumbar spine treated with conservative treatment and percutaneous vertebroplasty. METHODS: The retrospective study with inclusion criteria focused on osteoporotic fractures of the thoracolumbar junction (T10-L2). Clinical outcomes were evaluated by using the VAS, Oswestry and SF36 questionnaires. Radiographic outcomes were evaluated by comparing the following sagittal parameters: body angle, sagittal index of fractured vertebral body and adjacent vertebral segments kyphosis. Complications in terms of adjacent vertebral fractures and cement leakage are reported. RESULTS: Percutaneous vertebroplasty provided better vertebral body height restoration, but was associated with a higher incidence of adjacent fractures (20%) than conservative treatment (3.5%). This fact may explain why patients treated with percutaneous vertebroplasty had worse overall kyphotic alignment at final follow-up. Cement leakage was frequent, but always asymptomatic and generally no serious complications occurred. CONCLUSIONS: Percutaneous vertebroplasty represents a safe treatment for osteoporotic vertebral compression fractures, although it may be associated with a higher incidence of adjacent fractures and therefore worse thoracolumbar kyphosis and long-term follow-up than conservative treatment. These slides can be retrieved under Electronic Supplementary Material.

Correlation analysis between the magnetic resonance imaging characteristics of osteoporotic vertebral compression fractures and the efficacy of percutaneous vertebroplasty: a prospective cohort study.

BACKGROUND: To explore the relationship between the magnetic resonance imaging (MRI) characteristics of osteoporotic vertebral compression fractures (OVCFs) and the efficacy of percutaneous vertebroplasty (PVP). METHODS: A prospective study was conducted to analyze the clinical and imaging data of 93 patients with OVCFs treated via PVP. A visual analogue scale (VAS), the Oswestry Disability Index (ODI), and the Medical Outcomes Study(MOS) 36-Item short-form health survey (SF-36) were completed before surgery as well as 1 day and 1, 6, and 12 months after surgery. In addition, postoperative complications were recorded. According to the degree and ranges of bone marrow edema on MRI, the patients were divided into three groups: the mild (group A), moderate (group B), and severe (group C) bone marrow edema groups. Pain and dysfunction scores were compared across the three groups of patients before surgery as well as 1 day and 1, 6, and 12 months after surgery. RESULTS: The VAS, ODI, and SF-36 scores showed significant differences (P < 0.05) before and after surgery among the three groups. The ODI and SF-36 scores were significantly different (P < 0.05) at 1 day and 1 month after surgery among the three groups. Groups A and B showed significantly better pain relief than group C. Group B experienced better pain relief than group A. These results indicate that PVP was associated with better pain relief effects among patients with a greater extent of bone marrow edema. The edema ranges of the vertebral fractures were negatively correlated with the postoperative VAS and ODI scores 1 month after surgery, whereas the ranges were positively correlated with postoperative SF-36 scores 1 month after surgery. CONCLUSIONS: PVP is an effective treatment for OVCFs. Better outcomes were observed among patients with severe or moderate bone marrow edema rather than those with mild bone marrow edema. A greater degree of pain relief after PVP was correlated with faster recovery of the postoperative function. However, this correlation gradually became weak over time and disappeared 6 months after surgery. Therefore, PVP should be an option for early stage OVCFs, especially among patients with bone marrow edema signs on MRI.

Comparison of the effect of two different bone-targeted radiofrequency ablation (RFA) systems alone and in combination with percutaneous vertebroplasty (PVP) on the biomechanical stability of the metastatic spine.

INTRODUCTION: Radiofrequency ablation (RFA) and percutaneous vertebroplasty (PVP) are used independently and in combination to treat metastatically involved vertebrae with the aim of relieving pain, reducing tumour burden and providing bony mechanical stabilization. PURPOSE: The aim of this work was to characterize the effect of two bone-targeted RFA devices, alone and in combination with PVP, to improve strength and mechanical stability in vertebrae with osteolytic metastatic disease. METHODS: Simulated spinal metastases (n = 12) were treated with one of two bone-targeted RFA devices (bipolar cooled or bone coil RF electrodes), followed by PVP. Under axial compressive loading, spinal canal narrowing was measured in the intact specimen, after tumour simulation, post-RFA and post-PVP. RESULTS: RFA alone resulted in successful tumour shrinkage and cavitation, but further increased canal narrowing under loading. RFA combined with PVP significantly reduced posterior wall stability in samples where sufficient tumour shrinkage and cavitation were coupled with a pattern of cement deposition which extended to posterior vertebral body. CONCLUSIONS: RFA combined with cement deposition in the posterior vertebral body demonstrates significantly more stable vertebrae under axial loading.

Risk factors for predicting cement leakage following percutaneous vertebroplasty for osteoporotic vertebral compression fractures.

PURPOSE: The purpose of the present study is to identify independent risk factors for the occurrence of cement leakage (CL) during percutaneous vertebroplasty (PVP) for four different leakage types in treating osteoporotic vertebral compression fractures (OVCFs). METHODS: We retrospectively reviewed 292 patients who underwent PVP for single-level OVCF from January 2009 to March 2011. The influences of several potential risk factors that might affect the occurrence of CL were assessed using univariate and multivariate analyses. Cement leakage was evaluated by computed tomography and classified into four different types: through the basivertebral vein (B-type), the segmental vein (S-type), a cortical defect (C-type), and intradiscal leakage (D-type). RESULTS: Cement leakage was found in 227 of the 292 treated vertebrae. None of the parameters showed a statistically significant effect by univariate analysis. However, multivariate analysis showed that cement viscosity was an independent risk factor in B-type CL, fracture severity and fracture type were in S-type CL, fracture severity and presence of cleft on MRI were in C-type CL, and fracture severity, cortical disruption on MRI, presence of cleft on MRI and cement viscosity were in D-type CL. CONCLUSION: Each different vertebral fracture pattern has its own risk factors for CL. Identification of the above predicting factors for CL preoperatively might be helpful for more rigorous and strict patient selection criteria for the appropriate candidates for PVP.

[Delayed indications for additive ventral treatment of thoracolumbar burst fractures : What correction loss is to be expected]. / Zeitverzögerte Indikationsstellung zur additiv ventralen Versorgung thorakolumbaler Berstungsfrakturen : Welcher Korrekturverlust ist zu erwarten.

INTRODUCTION: There is a general consensus that unstable vertebral body fractures of the thoracolumbar junction with a B type fracture or a high load shear index need to be surgically stabilized, primarily by a dorsal approach. The authors believe that there are indications for an additional ventral spondylodesis in cases of reduction loss or a relevant intervertebral disc lesion in magnetic resonance imaging (MRI) 6 weeks after dorsal stabilization. However, in cases of unstable vertebral fractures it remains unclear if a delayed anterior spondylodesis will lead to unacceptable loss of initial reduction. MATERIAL AND METHODS: A total of 59 patients were included in this study during 2013 and 2014. All patients suffered from a traumatic vertebral fracture of the thoracolumbar junction and were initially treated with a dorsal short segment stabilization. All vertebral body fractures had a load shear index of at least 5 or were B type fractures. An x-ray control was carried out after 2 and 6 weeks and MRI was additionally performed after 6 weeks. An additional ventral spondylodesis was recommended in patients showing a reduction loss of at least 5° and in patients with relevant intervertebral disc lesions. The extent of the reduction loss was analyzed. Other parameters of interest were the fracture level, fracture classification, patient age and surgical technique (e.g. implant, index screw, laminectomy and cement augmentation). RESULTS: The patient collective consisted of 23 women and 36 men (average age 51 years ± 17 years). The mean reduction loss was 5.1° (± 5.2°) after a mean follow-up of 60 days (± 56 days). The reduction loss was significantly higher when polyaxial implants were used compared to monoaxial dorsal fixators (10.8° versus 4.0°, p < 0.001). There was a significantly higher reduction loss in those patients who received a laminectomy (11.3° versus 4.3°, p = 0.01) but there were no significant differences if an index screw was used (4.5° versus 5.3°). Additionally, there was a significantly lower reduction in the subgroup of patients 60 years or older who were stabilized using cement-augmented screws (3.9° versus 11.3°, p = 0.02). The mean reduction loss was 2.8° (± 2.5°) in patients treated with a monoaxial implant, cement-augmented if 60 years or older and without laminectomy (n = 39). There was no significant correlation between reduction loss and the other parameters of interest, such as fracture morphology with classification according to the working group on questions of osteosynthesis (AO) and McCormack or fracture level. CONCLUSION: Delayed indications for an additional ventral spondylodesis in patients with unstable thoracolumbar vertebral fractures and initial dorsal stabilization will cause no relevant reduction loss if monoaxial implants are used and laminectomy can be avoided. Additionally, cement augmentation of the pedicle screws seems to be beneficial in patients 60 years of age or older.

The incidence of secondary vertebral fracture of vertebral augmentation techniques versus conservative treatment for painful osteoporotic vertebral fractures: a systematic review and meta-analysis.

BACKGROUND: Percutaneous vertebroplasty (PVP) and balloon kyphoplasty (BKP) are minimally invasive and effective vertebral augmentation techniques for managing osteoporotic vertebral compression fractures (OVCFs). Recent meta-analyses have compared the incidence of secondary vertebral fractures between patients treated with vertebral augmentation techniques or conservative treatment; however, the inclusions were not thorough and rigorous enough, and the effects of each technique on the incidence of secondary vertebral fractures remain unclear. PURPOSE: To perform an updated systematic review and meta-analysis of the studies with more rigorous inclusion criteria on the effects of vertebral augmentation techniques and conservative treatment for OVCF on the incidence of secondary vertebral fractures. MATERIAL AND METHODS: PubMed, MEDLINE, EMBASE, SpringerLink, Web of Science, and the Cochrane Library database were searched for relevant original articles comparing the incidence of secondary vertebral fractures between vertebral augmentation techniques and conservative treatment for patients with OVCFs. Randomized controlled trials (RCTs) and prospective non-randomized controlled trials (NRCTs) were identified. The methodological qualities of the studies were evaluated, relevant data were extracted and recorded, and an appropriate meta-analysis was conducted. RESULTS: A total of 13 articles were included. The pooled results from included studies showed no statistically significant differences in the incidence of secondary vertebral fractures between patients treated with vertebral augmentation techniques and conservative treatment. Subgroup analysis comparing different study designs, durations of symptoms, follow-up times, races of patients, and techniques were conducted, and no significant differences in the incidence of secondary fractures were identified (P > 0.05). No obvious publication bias was detected by either Begg's test (P = 0.360 > 0.05) or Egger's test (P = 0.373 > 0.05). CONCLUSION: Despite current thinking in the field that vertebral augmentation procedures may increase the incidence of secondary fractures, we found no differences in the incidence of secondary fractures between vertebral augmentation techniques and conservative treatment for patients with OVCFs.

Analysis of intradiscal cement leakage during percutaneous vertebroplasty: multivariate study of risk factors emphasizing preoperative MR findings.

OBJECTIVE: Previous reports have shown that intradiscal cement leakage during percutaneous vertebroplasty (PVP) is related to several risk factors. The purpose of this study was to evaluate preoperative MRI scans for such risk factors. METHODS: The study retrospectively analyzed 136 patients (aged 43-93 years; 234 vertebral bodies) with osteoporotic compression fractures. All patients underwent both MRI and PVP. There were 28 men (20.59%) and 108 women (79.41%). Age, gender, bone mineral density (BMD) score, endplate cortical disruption, abnormal T2-weighted hyperintensity in adjacent discs, presence of Kümmell's disease, linear body fracture with extension to endplate, level of treated vertebral body and injected cement volume were considered risk factors for intradiscal cement leakage. RESULTS: Of the 234 vertebral bodies, 55 bodies from 42 patients with no endplate cortical disruption showed no adjacent intradiscal cement leakage. Of 179 bodies from 95 patients with endplate cortical disruption, 54 (30.17%) showed intradiscal cement leakage. Of the other possible risk factors, abnormal T2 hyperintensity in adjacent discs was significantly related to intradiscal cement leakage (P = 0.016). The other possible factors (age, gender, BMD score, Kümmell's disease, linear body fracture extending to the endplate, level of treated vertebral body and injected cement volume) were not related to intradiscal cement leakage. CONCLUSION: There was no adjacent intradiscal cement leakage without endplate cortical disruption. Abnormal T2 hyperintensity in adjacent discs may be related to intradiscal cement leakage, but only in the presence of endplate cortical disruption. Also, not having Kümmell's disease did not prevent intradiscal cement leakage. Thus, given these circumstances, careful cement injection is needed to reduce intradiscal cement leakage.

New vertebral fractures after percutaneous vertebroplasty for painful osteoporotic vertebral compression fractures: a clustered analysis and the relevance of intradiskal cement leakage.

PURPOSE: To perform clustered analysis of fracture-free probabilities of intact nontreated vertebrae after percutaneous vertebroplasty (PVP) in painful long-standing osteoporotic vertebral compression fractures (OVCFs) to determine risk factors for new vertebral fractures and estimate fracture-free probabilities of multiple intact nontreated vertebrae given their patient- and vertebra-specific covariate status. MATERIALS AND METHODS: Informed consent and institutional review board approval were obtained. A total of 115 patients who underwent PVP for 216 painful long-standing OVCFs were prospectively followed up to detect new OVCFs during the 1st postoperative year. A total of 1031 intact vertebrae were available for clustered analysis of fracture-free probabilities by using a Cox proportional hazard frailty model. A clustered analysis takes clustering or correlation of fracture-free survival probabilities of individual intact vertebrae within one patient into account to improve estimates of fracture-free probabilities and risk factors. Relevant patient- and vertebra-specific covariates were included. Volumetric analysis of intradiskal cement leakage was performed by using a receiver operating characteristic curve (ROC). RESULTS: Three- and 12-month vertebral fracture-free probability was 97.0% and 94.5%, respectively. Strong patient-level risk factors included low bone mineral density (hazard ratio [HR], 0.53 per unit increase), high spinal deformity index (HR, 2.23 per five units increase), and low fracture age (HR, 0.52 per 2 months increase). Strong vertebra-specific risk factors were thoracolumbar localization (HR, 2.33), vicinity to the treated level (adjacent level HR, 3.53), and presence of intradiskal cement leakage (HR, 8.21). Fracture-free probabilities of individual vertebrae were clustered within a patient (ie, not independent) (P = .009). The predicted 1-year fracture-free probability of an individual vertebra could be as high as 99.8% or as low as 19.9% based on absence or presence of risk factors, respectively. Larger intradiskal cement leakage volumes were associated with a higher likelihood of occurrence of new adjacent OVCFs (area under the ROC curve, 0.70). CONCLUSION: New vertebral fractures after PVP were clustered within patients and depended heavily on the presence or absence of both patient- and vertebra-specific risk factors. Intradiskal cement leakage was a pronounced augmentation-related risk factor, for which a volumetric association was found.

Investigational vertebroplasty safety and efficacy trial (INVEST): patient-reported outcomes through 1 year.

PURPOSE: To evaluate 1-year outcomes of the Investigational Vertebroplasty Safety and Efficacy Trial (INVEST), a blinded, randomized, controlled trial to investigate the effectiveness of percutaneous vertebroplasty in the treatment of osteoporotic vertebral compression fractures. MATERIALS AND METHODS: Patients were enrolled at 11 sites in the United States, the United Kingdom, and Australia by using an institutional review board-approved protocol and HIPAA compliance, and all patients provided written informed consent. Patients were randomized to undergo vertebroplasty or a control procedure. After 1 month, patients were allowed to cross over and undergo the alternate procedure. Coprimary outcomes were patient-reported function, measured with the modified Roland-Morris Disability Questionnaire (RDQ), and pain (on a scale of one to 10) at 1 year. Intention-to-treat (ITT) and as-treated (AT) analyses were used to compare outcomes. RESULTS: One hundred thirty-one participants (68 in the vertebroplasty group and 63 in the control group) were included in the analyses. Patients in both groups showed improvements in pain and function at 1 year. In ITT analyses, patients randomized to vertebroplasty did not differ from control subjects in terms of RDQ results (difference, 1.37 points; 95% confidence interval [CI]: -0.88, 3.62; P = .231) but reported lower levels of pain (difference, 1.02 points; 95% CI: 0.04, 2.01; P = .042). Eleven of 68 patients who underwent vertebroplasty (16%) and 38 of 63 control subjects (60%) crossed over and elected to undergo the alternate procedure (P < .001). In AT analyses, patients treated with vertebroplasty did not differ from control subjects in terms of RDQ results (difference, 0.66 points; 95% CI: -1.98, 3.30; P = .625) or pain (difference, 0.85 points; 95% CI: -0.35, 2.05; P = .166). CONCLUSION: Vertebroplasty may provide a modest reduction in pain at 1 year compared with a control procedure; however, no difference in functional disability was observed. Clinical trial registration no. NCT00068822.

Hospital burden of vertebral fractures in France: influence of vertebroplasty.

UNLABELLED: We described the whole population of patients hospitalized for vertebral fractures in France in 2009. Only 6.4 % of them were operated by vertebroplasty; these patients were younger and healthier than non-operated patients. INTRODUCTION: This study aims to describe the burden of vertebral fractures from the 2009 French Hospital National Database in acute care in people aged 60 years and over, with or without vertebroplasty. METHODS: All stays due to nonmalignant and nontraumatic vertebral fractures as primary cause were selected. Patients' characteristics were described and compared between patients with or without vertebroplasty. The in-patient mortality was compared to the one related to hip and upper humerus fracture in patients hospitalized during the same year. RESULTS: In 2009, 13,624 patients were hospitalized for vertebral fracture. Men accounted for 29.3 % of cases. Length of stay was 9.6 ± 8.2 days, higher in patients with at least one comorbidity than in patients without (11.2 ± 8.6 and 7.8 ± 7.2 days, respectively). The in-patient mortality was 0.9 %; it was 3.8 and 1.1 % for hip and upper humerus fractures, respectively. Vertebroplasty was performed in 6.4 % of them. Patients with vertebroplasty were younger (mean age of 75 ± 8 versus 79 ± 9 years), had a less duration of stay (7 ± 7.5 versus 9.8 ± 8.2 days), less comorbidities (at least one comorbidity, 45 versus 54 %), and less in-patient mortality (0.1 versus 0.9 %). Rehospitalization for vertebral fracture occurred in 9 and 6 % of the patient with and without vertebroplasty. CONCLUSION: This is the first French study assessing the national burden of vertebral fractures based on hospital data. In-hospital death rate is lower in patients with vertebroplasty, who are younger and have less comorbidities than the general population with vertebral fractures.

Value of percutaneous radiofrequency ablation with or without percutaneous vertebroplasty for pain relief and functional recovery in painful bone metastases.

OBJECTIVE: To evaluate the effectiveness of percutaneous radiofrequency (RF) ablation with or without percutaneous vertebroplasty (PV) on pain relief, functional recovery and local recurrence at 6 months' follow-up (FU), in patients with painful osseous metastases. MATERIALS AND METHODS: Thirty RF ablations were performed in 24 patients (mean age: 61 years) with bone metastases. Half of the patients had an additional PV. The primary end point was pain relief evaluated by a visual analogue scale (VAS) before treatment, and at 1 and 6 months' FU. Functional outcome was assessed according to the evolution of their ability to walk at 6 months' FU. Imaging FU was available in 20 out of 24 patients with a mean delay of 4.7 months. RESULTS: Reduction of pain was obtained at 6 months FU in 81% of cases (15 out of 18). Mean pretreatment VAS was 6.4 (±2.7). Mean VAS was 1.9 (±2.4) at 1 month FU, and 2.3 (±2.9) at 6 months' FU. Pain was significantly reduced at 6 months FU (mean VAS reduction = 4.1; P < 0.00001). Functional improvement was obtained in 74% of the cases. Major complications rate was 12.5 % (3 out of 24) with 2 skin burns, and 1 case of myelopathy. Local tumour recurrence or progression was recorded in 5 cases. CONCLUSION: Radiofrequency ablation is an effective technique in terms of pain relief and functional recovery for the treatment of bone metastases, which provides a relatively low rate of local recurrence.

Risk factors for new osteoporotic vertebral compression fractures after vertebroplasty: a systematic review and meta-analysis.

STUDY DESIGN: Literature review and meta-analysis. OBJECTIVE: To perform a systematic review and meta-analysis of risk factors for new osteoporotic vertebral compression fracture (VCF) after vertebroplasty. SUMMARY OF BACKGROUND DATA: New osteoporotic VCF is one of the serious complications of vertebroplasty, and it is important to investigate the risk factors for such VCFs. The risk factors for new VCFs reported so far remain controversial because of limited data and lack of uniform measurements and evaluation. METHODS: We searched the electronic database of PubMed for case-control studies about the risk of new osteoporotic VCFs after vertebroplasty. RESULTS: A total of 116 studies were identified, of which 16 studies including 559 cases and 1736 controls met the inclusion criteria. The significant risk factors for new VCFs were low bone mineral density [BMD; standardized mean difference (SMD), -0.73; 95% confidence interval (CI), -1.26 to -0.20], low body mass index (BMI; SMD, -0.30; 95% CI, -0.51 to -0.10), and intradiscal cement leakage [odds ratio (OR), 2.13; 95% CI, 1.40-2.36]. The significant risk factors for new VCFs adjacent to the treated VCF were low BMD (SMD, -0.43; 95% CI, -0.76 to -0.09), low BMI (SMD, -0.52; 95% CI, -0.81 to -0.22), and intradiscal cement leakage (OR, 2.61; 95% CI, 1.63-4.17). Low BMD, low BMI, intradiscal cement leakage, cement volume, surgical approach, age, sex, and thoracolumbar junction fracture were all not significant risk factors for new VCFs away from the original VCF. Only one study reported dynamic characteristics as risk factors for new VCFs. CONCLUSIONS: The results of this meta-analysis strongly suggested that patients with low BMD, low BMI, and intradiscal cement leakage were at high risk for new VCFs after vertebroplasty, and risk-reduction options should be considered for such patients.

[Current status of vertebroplasty and kyphoplasty in Germany: an analysis of surgical disciplines]. / Aktueller Stand der Vertebroplastie und Kyphoplastie in Deutschland: Eine Untersuchung in den operativen Fachdisziplinen.

OBJECTIVE: This study was performed to provide an overview of the current practice of balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PVP) in Germany. All surgical departments were evaluated for indications, experience and expertise, and the complications. METHODS: Questionnaires were mailed to 1330 surgical departments. RESULTS: A total of 582 (43.76%) surveys were returned; 257 departments perform neither BKP nor PVP. Osteoporotic compression fractures and to a lesser extent hemangiomas and metastasis were treated. About 30% of the BKP users consider traumatic vertebral fractures in young patients as an indication, 76% of the respondents perform further spinal surgery, and 71% of the users operate within the first 2 weeks. For both interventions cement leakage is the most common complication. CONCLUSION: Nationwide kyphoplasty and vertebroplasty are widely used by surgeons. The number of users as well as the annual number of cases in each center are increasing continuously. The partially incomplete present state of the studies must be validated by future high-quality, randomized studies.

Vertebroplasty and kyphoplasty in the United States: provider distribution and guidance method, 2001-2010.

OBJECTIVE: The purpose of this study was to determine the utilization by specialty and guidance method for vertebral augmentation (including vertebroplasty and kyphoplasty) in the United States from 2001 to 2010. MATERIALS AND METHODS: Using the 2001 through 2010 United States part B Medicare claims database, we studied the CPT-4 (Current Procedural Terminology, 4th ed.) codes used for thoracic (22520) and lumbar (22521) vertebroplasty, thoracic (22523) and lumbar (22524) kyphoplasty, and the method of radiologic guidance (76012 for fluoroscopy and 76013 for CT). For each of these codes, volume and physician specialty were tabulated. RESULTS: Radiologists performed 73% of Medicare-reimbursed vertebroplasty procedures in the United States in 2001-2010 and 30% of kyphoplasty procedures from 2006 to 2010. The majority were performed by nonradiologists, most notably orthopedic surgeons, who accounted for 40%. Although there was a decrease in utilization of vertebroplasty and kyphoplasty from 2009 to 2010, the number of vertebroplasties increased by 72.9% from 2001 to 2010, and the number of kyphoplasties increased by 12.0% from 2006 to 2010. Fluoroscopy is nearly universal as a guidance method for both vertebroplasty and kyphoplasty. CONCLUSION: This study shows that despite controversy regarding the long-term efficacy of vertebral augmentation, including vertebroplasty and kyphoplasty, utilization has risen since these procedures have been instituted and fluoroscopy is nearly universal as a guidance method. For vertebroplasty, the decrease in utilization from 2007 to 2009 may be explained in part by a combination of the initiation of kyphoplasty codes in 2006 and the August 2009 Kallmes et al. and Buchbinder et al. publications. Decreased utilization of both vertebroplasty and kyphoplasty from 2009 to 2010 may also be partly due to these publications.

Osteoporotic vertebral fractures without compression: key factors of diagnosis and initial outcome of treatment with cement augmentation.

INTRODUCTION: Because of the nonspecific symptoms and unapparent radiographic findings, occult osteoporotic vertebral fractures (VFs) have a high rate of missed diagnosis, and the treatment of these fractures has rarely been discussed in the literature. We investigated diagnostic key factors of such occult VFs and evaluated the effects of cement augmentation in these patients. METHODS: A total of 225 patients with VFs treated with vertebroplasty (VP) or kyphoplasty (KP) were retrospectively analyzed. All patients have taken preoperatively magnetic resonance imaging (MRI) including T1/T2-weighted images and short tau inversion recovery (STIR) sequences, and 45 patients met the inclusion criteria. Clinical outcomes were evaluated by comparing visual analog scale (VAS) and Oswestry disability index (ODI) values preoperatively, postoperatively, and at the final follow-up. RESULTS: MRI (T1 and STIR sequences) showed bone marrow edema in all fresh fractures including occult VFs and concomitant VFs; five patients showed no abnormality signal in their T2-weighted sequences of occult VFs. While 40 patients underwent KP, and five patients underwent VP. We did not find delayed collapsed fractures in the augmented occult VFs in both groups after operation. Both groups had significant improvement in pain and functional activity after the intervention (p<0.01). CONCLUSION: The presence of previous or concomitant VFs leads to further imaging examination, which helps identify the occult VFs. Preoperative MRI examination especially T1 and STIR sequences plays a vital role in the early diagnosis of occult VFs. Except for significant pain relief and functional improvement, VP and KP can effectively prevent delayed vertebral collapse of occult VFs comparing to previous reported data.

[Cement augmentation for osteoporotic compression fractures]. / Zementaugmentation bei osteoporotischen Wirbelkompressionsfrakturen.

High-quality evidence has raised significant questions on the widespread use of vertebroplasty in the treatment of osteopenic vertebral insufficiency fractures. Further research is shifting the burden of proof on procedures such as balloon kyphoplasty and other interventions. New prospective clinical trials may need to consider including sham arms to enhance their relevance.