A novel vertebroplasty technique using a larger-diameter needle for thoracolumbar osteoporotic vertebral compression fracture.

ABSTRACT: Percutaneous vertebroplasty (VP) and kyphoplasty (KP) are well-established minimally invasive surgical procedures for the treatment of osteoporotic vertebral compression fractures (OVCF). However, some drawbacks have been reported regarding these procedures, including height loss, cement leakage, and loss of the restored height after balloon deflation. We performed a novel VP technique to minimize these limitations of conventional procedures. This study aimed to compare radiological and clinical outcomes of our method using a larger-diameter needle versus conventional VP (using a smaller needle) for thoracolumbar OVCF.From April 2016 to May 2017, 107 consecutive patients diagnosed with thoracolumbar OVCF were enrolled. Patients were divided into two groups: group 1 underwent conventional VP, i.e., using a smaller diameter needle, and group 2 underwent VP through a modified method with a larger-diameter needle. For radiological evaluation, parameters related to anterior vertebral height (AVH) and segmental angle were assessed using plain standing radiographs, and patient-reported outcomes were evaluated using the visual analog scale. Cement injection amount and leakage pattern were also analyzed. Group 2 showed a larger anterior vertebral height change than group 1 immediately postoperatively and one year postoperatively. The 1-year postoperatively-AVH maintained better in group 2 than in group 1. Group 2 showed more significant improvement of segmental angle immediately postoperatively than group 1 (3.15° in group 1 vs 9.36° in group 2). IYPo-visual analog scale significantly improved in both groups, with greater improvement in group 2 (3.69 in group 1 vs 5.63 in group 2). A substantially larger amount of cement was injected, with a lower leakage rate in group 2 than in group 1.A novel VP technique using a larger-diameter needle showed superior radiological and clinical outcomes than conventional VP. Therefore, it can be considered a useful treatment option for OVCF.

The evaluation of the treatment for old osteoporotic vertebral compression fracture pain by percutaneous vertebroplasty.

The aim of the present study was to evaluate the clinical effect of percutaneous vertebroplasty (PVP) in the treatment of old osteoporotic vertebral compression fracture (OVCF) pain.A retrospective study was conducted on the clinical and imaging data of 31 patients with old OVCF treated by PVP from June 2010 to September 2011. Clinical efficacy was evaluated by the visual analog scale (VAS) scores, the oswestry disability index (ODI), the Cobb angle, and vertebral kyphotic angle at pre-operation and post-operation 3 days, 3 months, and 12 months.The VAS scores and ODI scores of 3 day, 3 month, and 12 month after PVP were significantly improved compared with those before operation (P < .05), but the Cobb angle and vertebral kyphosis angle were not significantly improved compared with those before operation (P > .05).PVP can effectively relieve the pain caused by old OVCF, and the motor ability of the patients is improved obviously. However, the recovery of Cobb angle and vertebral kyphosis angle was not obvious.

Efficacy and safety of high-viscosity cement in percutaneous vertebroplasty for treatment of Osteoporotic vertebral compression fractures: A retrospective cohort study.

To evaluate the efficacy and safety of high viscosity bone cement in the percutaneous vertebroplasty (PVP) for treatment of single-level osteoporotic vertebral compression fractures.Eighty patients were enrolled in this study. All patients were received PVP, and they were divided into 2 groups according to the viscosity of bone cement, either high viscosity bone cement (HV group) or low viscosity cement (LV group). Oswestry Disability Index questionnaire and visual analog scale as clinical assessments were quantified. The operative time and injected bone cement volume were recorded. The anterior vertebral height (AVH) and bone cement leakage were evaluated in the radiograph.No significant difference was observed in the operative time. Both groups showed significant improvements in pain relief and functional capacity status (visual analog scale and Oswestry disability index scores) after surgery. Less bone cement volume was injected into the the injured vertebra in the HV group and statistical significance was found between both groups. In the HV group, there was lower leakage rate and less patients of severe leakage compared with the LV group. However, the correction of AVH showed no significant differences between the 2 groups and no significant loss of AVH was observed in 2 groups.High-viscosity and low-viscosity PVP have the similar effects in improving quality of life and relieving pain. There were lower cement leakage rate and less patients of severe leakage in the PVP with high-viscosity bone cement.

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.

The Top 100 Most-Cited Articles on Kyphoplasty and Vertebroplasty.

INTRODUCTION: Over the last several decades, both percutaneous kyphoplasty (PKP) and percutaneous vertebroplasty (PVP) have been used for pain relief in patients with osteoporotic vertebral compression fractures. The purpose of our study was to use citation analysis to identify and review the top 100 most-cited publications regarding PKP and PVP. METHODS: All databases of the Web of Science were searched using the keywords "kyphoplasty" and "vertebroplasty." All publications with >100 citations were identified and the results were ranked in descending order of citations. The 100 most-cited publications were included for analysis. RESULTS: A total of 6271 publications on PKP and PVP were identified. The number of citations of the 100 most-cited studies ranged from 735 to 109, with a mean of 225.3 citations per study. The most productive period was 2001-2010, which produced 79 of the top 100 publications. Thirteen journals published these 100 studies, with Spine publishing the largest number (23) of studies. Most of the identified articles originated in the United States, with France and Switzerland found to be the next most heavily represented countries of origin of the 11 countries that produced them. Most of the studies focused on treatment of osteoporotic vertebral compression fractures, followed by pathologic fractures caused by tumors. CONCLUSIONS: We identified the 100 most-cited publications on PKP and PVP and performed a bibliometric analysis characterizing distinguishing features of these studies. This list can help guide clinical decision making and future research directions as clinicians and researchers continue to explore these controversial therapeutic techniques.

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.

Posterior Fixation Combined with Vertebroplasty or Vertebral Column Resection for the Treatment of Osteoporotic Vertebral Compression Fractures with Intravertebral Cleft Complicated by Neurological Deficits.

PURPOSE: The aim of the current study was to evaluate the relative benefits of posterior fixation combined with vertebroplasty (PFVP) or vertebral column resection (PVCR) for osteoporotic vertebral compression fractures (OVCFs) with intravertebral cleft (IVC) complicated by neurological deficits. METHODS: From June 2010 to January 2015, 45 consecutive patients suffering OVCFs with IVC and spinal cord injuries were treated with PFVP or PVCR in our department. The visual analogue scale (VAS) score, anterior vertebral height (AVH), posterior vertebral height (PVH), local kyphotic angle (LKA), and neurologic function were evaluated and compared, and the operative duration, blood loss, and complications were also recorded. RESULTS: They all achieved excellent pain relief, vertebral height recovery, and kyphosis correction one month after surgery, and no significant differences existed between the two groups. No significant differences were observed between the 1-month postoperative and final follow-up VAS, AVH, and LKA values in the PVCR group (P > 0.05), while AVH and LKA worsened in the PFVP group at the final follow-up (P < 0.05). Similarly, the initial improvements in VAS scores decreased over time (P < 0.05). Neurologic function improved in both groups, and no significant differences were observed between the 2 groups either preoperatively or postoperatively (P > 0.05). The blood loss and operative duration were significantly lower in the PFVP group than those in the PVCR group (P < 0.05). CONCLUSION: Compared with PVCR, PFVP had equivalent short-term clinical outcomes with less blood loss and operative duration which can be very beneficial for treating elderly patients with extreme comorbidities in this condition. However, based on the long-term efficacy of pain relief, vertebral height maintenance, and deformity correction, PVCR is a more reasonable choice.

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.

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.

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.

Use of corticosteroids is not associated with repeated vertebroplasty or kyphoplasty within one year after the surgery in patient older than 50 years.

OBJECTIVE: The aim of this study was to investigate whether corticosteroid use increases the incidence of repeated PVP or kyphoplasty patients older than 50 years. METHODS: This study enrolled the data of 2,753 eligible patients from the Taiwan National Health Insurance Research Database who were exposed to systemic corticosteroids for at least 3 months during the first year preceding the first PVP or kyphoplasty. These steroid users were matched 1:1 in age, sex, and the index date of surgery with non-user controls during the enrollment period. All patients were followed for 1 year after the first PVP or kyphoplasty. The incidence of repeated PVP or kyphoplasty was compared between the steroid users and controls. A Cox proportional hazards model was developed to account for multiple confounding factors. RESULTS: The number of patients receiving repeated PVP or kyphoplasty was 233 (8.46%) and 205 (7.45%) in the corticosteroid and control groups, respectively. The Cox proportional hazards model revealed no association between corticosteroid use and repeated PVP or kyphoplasty. CONCLUSIONS: Systemic corticosteroid use for longer than 3 months is not associated with repeated PVP or kyphoplasty within one year of surgery in patient older than 50 years old. LEVEL OF EVIDENCE: Level III, Therapeutic study.

Serious Adverse Events Associated with Readmission Through One Year After Vertebral Augmentation with Either a Polyetheretherketone Implant or Balloon Kyphoplasty.

BACKGROUND: The KAST (Kiva Safety and Efficacy) investigation device exempt (IDE) study indicated that the majority of patients responded equally well to vertebral augmentation using either an implant-based approach or balloon kyphoplasty (BK). Additional investigation has suggested that a subset of patients may benefit further by avoiding repeated readmissions due to serious adverse events (SAEs) if they receive one vertebral augmentation approach over another. OBJECTIVES: The primary aim was to assess the effect of 2 different augmentation procedures on readmission rates for SAEs. STUDY DESIGN: The KAST trial is a pivotal, multicenter, randomized, controlled trial conducted to evaluate an implant-based vertebral augmentation approach (implant) against BK. Post-hoc analysis was performed to evaluate SAEs and readmission rates. SETTING: Twenty-one sites in North America and Europe. METHODS: The treatment effect of vertebral implant versus BK on SAEs requiring unplanned readmission was evaluated by estimating the risk of SAEs associated with readmissions in KAST while controlling for key baseline covariates using multivariate Poisson regression modeling. RESULTS: Forty (27.8%) patients with implants had 69 SAEs associated with readmission compared to 44 (31.2%) patients with BK having 103 events. The risk for all SAEs leading to readmission was 34.4% lower with the implant than for BK (95% confidence interval = 11.1%, 51.7%; P < 0.01). Multivariate analysis showed that the risk of SAEs associated with readmission was decreased in subjects treated with the implant compared to BK, and increased in patients with prior histories of vertebral compression fractures (VCFs) or significant osteoporosis. LIMITATIONS: The power of the KIVA study was based on clinical efficacy criteria to meet FDA requirements and recommendations for equivalency or noninferiority. The primary endpoint in this post-hoc analysis is SAEs associated with readmissions; as a result, the sample size is underpowered, although the results remain significant. CONCLUSION: The augmentation approaches compared here have similar pain relief and quality of life effects; the implant showed a lower risk of readmissions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01123512. Key words: Vertebral compression fracture, kiva implant, balloon kyphoplasty, vertebroplasty, health economics, osteoporosis.

Medicare Utilization of Vertebral Augmentation 2001 to 2014: Effects of Randomized Clinical Trials and Guidelines on Vertebroplasty and Kyphoplasty.

PURPOSE: Vertebral fractures have a substantial impact on the health and quality of life of elderly individuals as one of the most common complications of osteoporosis. Vertebral augmentation procedures including vertebroplasty and kyphoplasty have been supported as means of reducing pain and mitigating disability associated with these fractures. However, use of vertebroplasty is debated, with negative randomized controlled trials published in 2009 and divergent clinical guidelines. The effect of changing evidence and guidelines on different practitioners' utilization of both kyphoplasty and vertebroplasty in the years after these developments and publication of data supporting their use is poorly understood. METHODS: Using national aggregate Medicare claims data from 2002 through 2014, vertebroplasty and kyphoplasty procedures were identified by provider type. Changes in utilization by procedure type and provider were studied. RESULTS: Total vertebroplasty billing increased 101.6% from 2001 (18,911) through 2008 (38,123). Total kyphoplasty billing frequency increased 17.2% from 2006 (54,329) through 2008 (63,684). Vertebroplasty billing decreased 60.9% from 2008 through 2014 to its lowest value (14,898). Kyphoplasty billing decreased 8.4% from 2008 (63,684) through 2010 (58,346), but then increased 7.6% from 2010 to 2013 (62,804). CONCLUSIONS: Vertebroplasty billing decreased substantially beginning in 2009 and continued to decrease through 2014 despite publication of more favorable studies in 2010 to 2012, suggesting studies published in 2009 and AAOS guidelines in 2010 may have had a persistent negative effect. Kyphoplasty did not decrease as substantially and increased in more recent years, suggesting a clinical practice response to favorable studies published during this period.

Surgeon's and Patient's Radiation Exposure Through Vertebral Body Cement Augmentation Procedures: A Prospective Multicentric Study of 49 Cases.

OBJECTIVE: Vertebral body cement augmentation as a treatment option for osteoporotic or traumatic fractures has become increasingly popular during the past decade. However, these surgical procedures require numerous fluoroscopic examinations, resulting in high radiation exposure for the patient and the surgical team. The aim of this study was to evaluate the level of radiation exposure of the spine surgeon and the patient during these percutaneous procedures. METHODS: Forty-nine patients admitted for single- or 2-level vertebral compression fracture were prospectively included and treated with vertebral body cement augmentation. For each procedure, radiation dose was measured on the surgeon's whole body, lens, and extremities as well as patient irradiation. Each surgeon wore 2 thermoluminescent dosimeters to measure lens and extremities radiation exposure and 1 electronic personal dosimeter. Patient clinical and surgical data, effective dose to patient, and surgeon were analyzed. RESULTS: Mean operative time was 31.5 ± 11.7 minutes. The average fluoroscopic time was 61.0 ± 27.1 seconds. The average whole-body radiation dose per procedure was 1.4 ± 2.1 µSv. The average equivalent dose to lens and extremities were 44 µSv and 59 µSv, respectively. CONCLUSIONS: Values of radiation doses for surgeon and patient were lower than those reported in the previous literature. The recommended annual dose limit is set to 500 mSv for extremities and 150 mSv for lens. According to our results, the exposure dose to the eye exceeds the annual limit after 3500 procedures. However, there is increasing concern among surgeons about radiation exposure, and there is still a need for solutions as preventive measures.

Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study.

STUDY DESIGN: A prospective randomized clinical trial. OBJECTIVE: In this study, we determine whether percutaneous vertebroplasty (PVP) offers extra benefits to aged patients with acute osteoporotic vertebral compression fractures (OVCFs) over conservative therapy (CV). SUMMARY OF BACKGROUND DATA: OVCFs are common in the aged population with osteoporosis. While the optimal treatment of aged patients with acute OVCFs remains controversial, PVP, a minimally invasive procedure, is a treatment option to be considered. METHODS: Patients aged at 70 years or above with acute OVCF and severe pain from minor or mild trauma were assigned randomly to PVP and CV groups. The primary outcome was pain relief as measured by VAS score in 1-year follow-up period. The second outcome was quality of life assessed with ODI and Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). Patient satisfaction surveys were also recorded. RESULTS: A total of 135 patients were enrolled, and 107 (56 in PVP group; 51 in CV group) completed 1-year follow-up. In PVP group, the vertebroplasty procedure was performed at a mean of 8.4 ±â€Š4.6 days (range, 2-21 days) after onset. Vertebroplasty resulted in much greater pain relief than did conservative treatment at postoperative day 1 (P < 0.0001). At every time point of follow-up, pain relief and quality of life were significantly improved in PVP group than in CV group at 1 week, 1 month, 3 months, 6 months, and 1 year (all P < 0.0001). The final follow-up surveys indicated that patients in PVP group were significantly more satisfied with given treatment (P < 0.0001). In addition, lower rate of complications was observed in PVP group (P < 0.0001). CONCLUSION: In aged patients with acute OVCF and severe pain, early vertebroplasty yielded faster, better pain relief and improved functional outcomes, which were maintained for 1 year. Furthermore, it showed fewer complications than conservative treatment. LEVEL OF EVIDENCE: 2.

Use and evaluation of a semi-permeable mesh implant in vertebral augmentation for the treatment of painful osteoporotic vertebral compression fractures.

OBJECTIVE: To assess the efficacy of a semi-permeable mesh implant in the treatment of painful thoracic and lumbar osteoporotic vertebral compression fractures. METHODS: Patients with painful thoracic and lumbar osteoporotic vertebral compression fractures which were refractory to conventional medical management and less than 3 months of age were considered possible candidates for this vertebral augmentation technique. Data recorded for the procedure included patient age, gender, fracture level and morphology, mesh implant size, amount of cement injected, cement extravasation, complications, and pre- and post-procedure numeric pain scores and Oswestry Disability Index (ODI) scores. RESULTS: 17 patients were included in this retrospective study; 12 women and 5 men, with an average age of 78.6 years. Each patient had one level treated with the mesh implant; 4 thoracic levels and 13 lumbar levels. The 10×15 mm implant was used in 13 treated vertebrae, including the two thoracic vertebrae; the 10×20 mm implant was used to treat 3 lumbar vertebrae, and one 10×25 mm implant was used to treat an L1 vertebra. An average of 2.4 mL of acrylic bone cement was injected, and there was fluoroscopic evidence of a small amount of cement leakage in one case. No patient related complications were seen and there were no device failures. All patients, followed-up to at least 3 weeks, showed significant pain relief. The average pretreatment numeric pain score of 9 and ODI of 50 decreased to an average post-treatment score of 0.6 and 12, respectively (p<0.001). CONCLUSIONS: Vertebral augmentation with a semi-permeable mesh stent implant can be used to effectively and safely treat osteoporotic vertebral compression fractures within the lower thoracic and lumbar spine.

Vertebral Augmentation After Recent Randomized Controlled Trials: A New Rise in Kyphoplasty Volumes.

PURPOSE: In 2009, the results of two randomized controlled trials refuting the effectiveness of vertebroplasty compared with sham procedures were published in a leading journal. The purpose of the present study was to evaluate the impact of these randomized trials on subsequent volume and utilization rates of vertebral augmentation (VA) in the United States. METHODS: Using nationwide Medicare Part B databases, Current Procedural Terminology, version 4, codes for thoracic and lumbar vertebroplasty and kyphoplasty were studied from 2006 to 2013 (codes 22520 to 22525). The total volumes of procedures were determined and utilization rates were calculated. Volumes and rates by provider specialty were also studied. RESULTS: The total volume of VA procedures peaked in 2008 at 101,807 and thereafter fell steadily to 80,940 in 2013. The utilization rates per 100,000 beneficiaries also showed a similar trend. Radiologists performed the largest number of VA procedures in 2013 (33,618 procedures [42%]), followed by orthopedic surgeons (19,886 procedures [25%]). After 2009, vertebroplasty volumes decreased sharply. Kyphoplasty volumes increased in 2011, after an initial decrease in 2010. The divergent trend in the volumes of the two procedures persisted through 2013. CONCLUSIONS: After the publication of the two trials' results in 2009, vertebroplasty volumes and rates decreased sharply. However, there is an emerging trend toward performing more kyphoplasty procedures, mitigating the decrease in total volume of VA procedures. Radiologists have the strongest role in performing these procedures among all medical specialties.

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.