Kyphoplasty in the treatment of occult and non-occult metastatic vertebral tumors.

To compare the efficacy and safety of kyphoplasty (KP) in the treatment of occult metastatic vertebral tumors (OMVT) and non-occult metastatic vertebral tumors (MVT).From January 2013 to December 2017, 65 cases of occult metastatic vertebral tumors and 82 cases of metastatic vertebral tumors were selected and divided into 2 groups. After KP, they were followed up by a year of outpatient visits and telephone calls. The visual analogue scale (VAS) and Oswestry disability index (ODI) scores, the amount of bone cement injected, the change of vertebral height and the incidence of complications were recorded, compared and analyzed by SPSS software. t test was used to compare the differences between the same group of patients at different times and between the 2 groups of patients.In the OMVT group, the operation time was 24.52 ±â€Š4.24 minutes, the fluoroscopy time was 10.18 ±â€Š1.53 minutes and the volume of bone cement was 3.62 ±â€Š0.93 ml. The VAS score decreased from 7.26 ±â€Š01.08 preoperatively to 2.77 ±â€Š0.93 postoperatively (P < .01). The ODI score decreased from 64.89 ±â€Š9.05 preoperatively to 25.82 ±â€Š4.63 postoperatively (P < .01). In the MVT group, the operation time was 26.63 ±â€Š4.61 minutes, the fluoroscopy time was 11.04 ±â€Š2.15 minutes and the volume of bone cement was 4.09 ±â€Š1.10 ml. The VAS score decreased from 7.73 ±â€Š0.94 preoperatively to 3.22 ±â€Š0.80 postoperatively (P < .01). The ODI score decreased from 69.20 ±â€Š7.14 preoperatively to 28.02 ±â€Š4.40 postoperatively (P < .01). The vertebral height of MVT patients was significantly improved after operation (P < .01), but there was no difference in OMVT patients (P > .05).Occult metastatic vertebral tumors can be detected by Magnetic Resonance Imaging (MRI), and KP may be more effective and safer in the treatment of OMVT.

Unilateral percutaneous kyphoplasty for lumbar spine: A comparative study between transverse process-pedicle approach and conventional transpedicular approach.

Anatomical differences of unilateral percutaneous kyphoplasty (PKP) between transverse process-pedicle approach (TPPA) and conventional transpedicular approach (CTPA) are not well discussed. To investigate the anatomical distinctions of unilateral PKP between TPPA and CTPA, we have discussed the unilateral PKP through a 3-dimensional-computed tomography database.Five hundred lumbar spines from 100 patients have been retrospectively collected and unilateral CTPA and TPPA were simulated. Distance between the entry point and the midline of the vertebral body (DEM), the puncture inclination angle (PIA), and the success rate (SR) of puncture were measured and compared.The male presented with significantly larger DEM than the female. The TPPA group presented with larger DEM than the CTPA group according to different level, the difference was 1.5 ±â€Š1.1 mm to 3.8 ±â€Š2.3 mm. The PIAs in the TPPA group were larger than that in the CTPA group. The SR including 1 side SR and bilateral SR was 72.0% in the CTPA group and 98.0% in the TPPA group. Compared with CTPA group, the SR in TPPA group was significantly higher for L1 to L4 no matter in the left, right side and female patients.The TPPA group presented with more lateral entry point, larger PIAs and higher SRs than that in the CTPA group. PKP surgery through a TPPA was safer and could provide a more symmetrical distribution of bone cement than the CTPA group.

Is it necessary to approach the compressed vertebra bilaterally during the process of PKP?

OBJECTIVE: To assess the clinical and radiological outcomes following unilateral or bilateral approach in percutaneous kyphoplasty (PKP) for treatment of osteoporotic vertebral compression fractures (OVCF). DESIGN: Prospective comparative study. SETTING: University affiliated hospital. PARICIPANTS: From 2012 through 2016, those MRI-diagnosed single-level lumbar OVCF patients. INTERVENTIONS: They were randomly assigned for treatment with unilateral or bilateral PKP. OUTCOME MEASURES: We assessed the patient' health status with the Oswestry Disability Index (ODI) questionnaire. Anteroposterior and lateral standing radiographs were obtained to measure the vertebral height and kyphotic angle of the vertebral body in all patients. RESULTS: Eighty-five patients were finally enrolled in this investigation, including 42 in the unilateral and 43 in the bilateral group. The operation time, PMMA volume, radiation dose was 25.6 ± 4.2 minutes, 6.2 ± 3.5 ml and 0.88 ± 0.28 mSv in the unilateral group, while 36.6 ± 8.7 minutes, 8.5 ± 2.2 ml and 1.89 ± 1.05 mSv in the bilateral group, respectively (P < 0.05). The postoperative VAS and ODI were 2.7 ± 1.2 and 19.8 ± 6.4 compared to preoperative 8.7 ± 1.6 and 35.2 ± 4.3 in unilateral group, while 2.6 ± 1.3 and 19.7 ± 2.6 compared to preoperative 8.5 ± 1.3 and 36.7 ± 3.6 in bilateral group, respectively (P > 0.05). CONCLUSION: Both bilateral and unilateral PKP are relatively safe and provide effective treatment for patients with painful OVCF. However, unilateral PKP need less radiation dose, operation time and PMMA volume.

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.

Prospective randomized comparison of early versus newer-generation vertebral access devices for kyphoplasty.

INTRODUCTION: Kyphoplasty is an established method of treating osteoporotic vertebral body compression fractures. In recent years, several techniques to enhance the efficiency and outcomes of this surgery have been developed and implemented in clinical practice. In the present study, we assess the impact of two new access instruments on overall operation time and the administered dose area product in comparison with the standard access instrument used in our clinical practice. The two newer comparator devices have been designed with the intention of streamlining intraoperative workflow by omitting several procedural steps. MATERIALS AND METHODS: This was a single-center prospective randomized trial investigating three distinct access instruments compatible with the Joline Allevo balloon catheter system. Specifically, two newer access devices marketed as being able to enhance surgical workflow (Joline RapidIntro Vertebra Access Device with a trocar tip and Joline SpeedTrack Vertebra Introducer Device with a short, tapered tip) were compared with the older, established Joline Vertebra Access Device from the same firm. Consecutive eligible and consenting patients scheduled to undergo kyphoplasty for osteoporotic vertebral compression fracture refractory to conservative, medical treatment during the period May 2012-August 2015 were randomized to receive surgery using one of the three devices. Besides the use of the trial instruments, all other preoperative, intraoperative and postoperative care was delivered according to standard practice. RESULTS: 91 kyphoplasties were performed on 65 unique patients during the study period. The median operation time across the three groups was 29 min (IQR 22.5-35.5) with a median irradiation time of 2.3 min (IQR 1.2-3.4). The median patient age was 74 years (IQR 66-80). The groups did not significantly differ in terms of age (p = 0.878), sex (p = 0.37), T score (p = 0.718), BMI (p = 0.285) or the applied volume of cement (p = 0.792). There was no significant difference between the treatment groups with respect to surgical duration (p = 0.157) or dose area product (p = 0.913). CONCLUSIONS: Although use of the two newer-generation access instruments were designed to involve fewer unique steps per operation, their use was not associated with reduction in surgical duration, irradiation time or dose area product administered compared with the older, established vertebral access device. Care should be taken to evaluate the impact of new instruments on key surgery-related parameters such as surgical duration and radiation exposure and claims made about new instruments should be assessed a structured fashion.

PKP/PVP combine chemotherapy in the treatment of multiple myeloma patients with vertebral pathological fractures: minimum 3-year follow-up of 108 cases.

BACKGROUND: Multiple myeloma (MM) is a blood system malignant tumor, which often leads to osteolytic bone destruction, and the vertebral column is the primary site of involvement. However, the efficacy and prognosis of percutaneous kyphoplasty/vertebroplasty (PKP/PVP) for simple vertebral pathological fractures in patients with multiple myeloma are not yet unified. The primary objective of this study was to investigate the efficacy and prognosis of PKP/PVP in the treatment of multiple myeloma patients with vertebral pathological fractures. METHODS: A total of 108 patients with MM from Beijing Chao-Yang Hospital from 2007 to 2013 were enrolled. Of these, 52 patients underwent PKP/PVP surgery and chemotherapy (surgery group) and 56 received only chemotherapy (chemotherapy group). The age, gender, International Staging System (ISS), fracture location, segment, visual analog scale (VAS), Oswestry Disability Index (ODI), comprehensive treatment satisfaction, stem cell transplantation, overall survival (OS), mortality rate, and the cause of death of patients were recorded; the mean follow-up time was 42.46 months. RESULTS: The average age of patients in surgery and chemotherapy groups was 60.8 years and 58.1 years, and the mean survival time was 41.98 months and 43.30 months, respectively. The VAS score at 1 month and last follow-up after treatment in surgery group were significantly lower than those in the chemotherapy group (P < 0.05); the ODI at 1 month after treatment in the surgery group was significantly lower than that in the chemotherapy group (P < 0.05); no significant difference was observed in the 3-year mortality rate between surgery and chemotherapy groups. The number of patients who developed activity disorder in the surgery group was significantly less than that in the chemotherapy group (P < 0.05). The OS of patients in ISS stage III was significantly less than that in ISS stages I and II (P < 0.05). CONCLUSIONS: PKP/PVP surgery can greatly relieve the pain caused by fractures, reduce the risk of being completely bedridden and pulmonary infection, and improve the quality of life of patients; however, it did not affect mortality rate and overall survival time in patients. TRIAL REGISTRATION: As this was a retrospective study, it did not require ethical approval; all patients had signed informed consent when they received treatment, and all treatment options were voluntary.

Percutaneous Vertebral Augmentation for Vertebral Compression Fractures: National Trends in the Medicare Population (2005-2015).

STUDY DESIGN: Retrospective analysis of Medicare data OBJECTIVE.: To analyze trends of vertebral augmentation in the elderly Medicare population in the context of evolving evidence and varied medical society opinions. SUMMARY OF BACKGROUND DATA: Percutaneous vertebral augmentation offers a minimally invasive therapy for vertebral compression fractures. Numerous trials have been published on this topic with mixed results. The impact of these studies and societal recommendations on physician practice patterns is not well understood. METHODS: The Centers for Medicare and Medicaid Services annual Medicare Physician Supplier Procedure Summary database was examined for kyphoplasty and vertebroplasty procedures from 2005 through 2015. Top provider specialties were determined based on annual procedural volume, and grouped into the three broad categories of radiology, surgery, and anesthesia/pain medicine. Data entries were independently analyzed by provider type, site of service, submitted charges, and reimbursement rates for interventions during the study period. RESULTS: Between 2005 and 2015 total annual claims for vertebral augmentation procedures in the Medicare population increased from 108.11% (37,133-77,276) peaking in 2008 and declining by 15.56% in 2009. Radiology is the largest provider of vertebral augmentation by specialty with declining market shares from 71% in 2005 to 43% in 2015. The frequency of vertebroplasty declined by 61.7% (35,409-13,478) from 2005 to 2015 with reduction in Medicare reimbursement. Annual volume of kyphoplasty grew by 18.3% (48,725-57,646) with significant increase in reimbursement for office-based procedures ($728.50/yr, P < 0.001, R = 0.69). CONCLUSION: The annual volume of vertebral augmentation declined in 2009 following two negative trials on vertebroplasty. Although these publications had a persistent negative impact on practice of vertebroplasty, the overall frequency of vertebral augmentation in the Medicare population has not changed significantly between 2005 and 2015. Instead, there has been a significant shift in provider practice patterns in favor of kyphoplasty in increasingly outpatient and office-based settings. LEVEL OF EVIDENCE: 3.

Is vertebral body stenting in combination with CaP cement superior to kyphoplasty?

PURPOSE: In the evolution of the minimally invasive treatment of vertebral compression fractures, vertebral body stenting (VBS) was developed to reduce intraoperative and secondary loss of vertebral height. Particularly in combination with the usage of biodegradable cement, the influence of VBS on the rate of intraoperative complications and long-term outcome is unclear. The purpose of this study was to investigate the differences between balloon kyphoplasty (BKP) and VBS regarding their long-term clinical and radiological outcome in combination with calcium phosphate (CaP) application instead of polymethyl methacrylate (PMMA). METHODS: This retrospective study included 49 patients with fresh mono-segmental thoracolumbar fractures without neurological signs treated with VBS or BKP and CaP cement (Calcibone). The outcome was evaluated with the visual analogue pain scale (VAS), the Oswestry disability score (ODI), and radiologically assessed. RESULTS: In the course of the radiological follow-up, the VBS group showed statistically significant less vertebral height loss than the BKP group. However, with respect to VAS and ODI scores there were no statistically significant differences between the VBS and BKP group in the clinical follow-up. The rate of cement leakage was comparable in both groups. CONCLUSIONS: Both techniques facilitated good clinical results in combination with absorbable cement augmentation. In particular, the VBS enabled us to benefit from the advantages of the resorbable isothermic CaP cement with an improved radiological outcome in the long term compared to BKP. However, there was a mentionable loss of reduction in the follow-up in both groups compared to previously published data with PMMA cement. These slides can be retrieved under Electronic Supplementary Material.

Single balloon versus double balloon bipedicular kyphoplasty: a systematic review and meta-analysis.

INTRODUCTION: Kyphoplasty has been widely used to treat vertebral compression fractures (VCFs). In standard procedure of kyphoplasty, two balloons were inserted into the vertebral body through bipedicular and inflated simultaneously, while using a single balloon two times is also a common method in clinic to lessen the financial burden of patients. However, the effect and safety of single balloon versus double balloon bipedicular kyphoplasty are still controversy. METHODS: In this systematic review and meta-analysis, eligible studies were identified through a comprehensive literature search of PubMed, Cochrane library EMBASE, Web of Science, Wanfang, CNKI, VIP and CBM until January 1, 2018. Results from individual studies were pooled using a random or fixed effects model. RESULTS: Seven articles were included in the systematic review and five studies were consisted in meta-analysis. We observed no significant difference between single balloon and double balloon bipedicular kyphoplasty in visual analog scale (VAS), angle (kyphotic angle and Cobb angle), consumption (operation time, cement volume and volume of bleeding), vertebral height (anterior height, medium height and posterior height) and complications (cement leakage and new VCFs), while the cost of single balloon bipedicular kyphoplasty is lower than that of double balloon bipedicular kyphoplasty. The results of our meta-analysis also demonstrated that single balloon can significantly improve the VAS, angle and vertebral height of patients suffering from VCFs. CONCLUSION: This systematic review and meta-analysis collectively concludes that single balloon bipedicular kyphoplasty is as effective as double balloon bipedicular kyphoplasty in improving clinical symptoms, deformity and complications of VCFs but not so expensive. These slides can be retrieved under Electronic Supplementary Material.

Incidence of unexpected positive histology in kyphoplasty.

OBJECTIVE: Kyphoplasty and vertebroplasty have become one of the most frequent surgical procedures in the treatment of vertebral compression fractures. Often, the cause of compression fractures is lowered bone mineral density as in osteoporosis. In the differential workup, also pathologic vertebral compression fractures need to be ruled out. Importantly, imaging techniques alone cannot safely differentiate between invasive lymphatic and osteoporotic vertebral fracture. Our goal was to identify the degree of unexpected positive histology in kyphoplasty for presumed osteoporotic vertebral compression fracture. METHODS: We retrospectively analyzed all kyphoplasties performed between 2007 and 2015 at our institution. The data were acquired by reviewing our medical documentation system. The data analysis was done using Microsoft Excel. The statistical analysis was done using the Chi-squared test. RESULTS: We performed 130 kyphoplasties/vertebroplasties. A biopsy was taken in 97 (74.6%) cases. In 10 (10.3%) cases, the histology revealed a pathological fracture. From these patients, only in 3 (30%) cases, a positive histology was not expected. Meaning that there was no history of cancer and the radiological findings presumed an osteoporotic fracture. CONCLUSIONS: Therefore, we could demonstrate that the incidence of unexpected positive histology in vertebral compression fracture treated with kyphoplasty is significant (3.1%). As a conclusion, if a kyphoplasty is performed due to assumed osteoporotic vertebral compression fracture, a biopsy should be taken to safely rule out a pathological fracture caused by lymphatic bony invasion.

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.

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.

Percutaneous pedicle screw fixation plus kyphoplasty for thoracolumbar fractures A2, A3 and B2.

DESIGN: Retrospective cohort. PURPOSE: The aim of this study is to evaluate the effectiveness of percutaneous short fixation (PSFx) plus kyphoplasty (BP) for thoracolumbar fractures. METHODS: Thirty-six consecutive selected patients, aged 59 ± 17 years, with fresh single thoracolumbar A2, A3, and B2 AO-type fracture, received PSFx plus BP. The primary outcomes pain, and vertebral body deformity; and the secondary outcomes screw malposition, facet violation, PMMA leakage, adjacent segment degeneration (ASD) and loss of correction were evaluated. The f/up was 31 ± 7 months. RESULTS: Pain and kyphosis decreased and vertebral body heights increased significantly postoperation. PMMA leakage occurred in five cases; 6 (4 %) screws were grades III malpositioned in relation to pedicle; facet violation occurred in 8 (5.5 %) facets; loss of kyphosis correction was 3.68°; ASD occurred in two cases; interfacet fusion in ten (28 %) patients; Three patients were reoperated for different reasons. CONCLUSIONS: PSFx plus BP for thoracolumbar fractures reduces significantly spinal deformity and pain with few complications.

Comparison of unilateral versus bilateral percutaneous kyphoplasty for the treatment of patients with osteoporosis vertebral compression fracture (OVCF): a systematic review and meta-analysis.

PURPOSE: To compare the short- and long-term clinical outcomes, operation times, restoration rate, dosage of polymethylmeth-acrylate (PMMA) injected, complications and X-rays exposure frequency between unilateral and bilateral kyphoplasty approaches for the treatment of OVCF. STUDY DESIGN: Systematic review and meta-analysis. METHODS: Randomized or non-randomized controlled trials published up to April 2015 that compared the unilateral and bilateral PKP for the treatment of OVCF were acquired by a comprehensive search in the Cochrane Controlled Trial Register, PubMed, MEDLINE, EMBASE, Web of Science, OVID. Exclusion criteria were patients with neoplastic etiology (metastasis or myeloma), infection, neural compression syndrome, invasive and degenerative disease, traumatic fracture, re-operation, neurological deficits, significant scoliosis and spinal stenosis. The main end points included: operation times, the short- and long-term postoperative Visual Analogue Scale (VAS) scores, the short-term postoperative Oswestry Disability Index (ODI), restoration rate, dosage of PMMA injected, cement leakage, X-ray exposure frequency and postoperative adjacent-level fractures. RESULTS: A total of 8 studies involving 428 patients were included in the meta-analysis. The mean operative time was shorter in the unilateral groups compared with the bilateral groups [P < 0.05, weighted mean difference (WMD) -19.74 (-30.56, -8.92)]. There was no significant difference in the short-term postoperative VAS scores [P > 0.05, WMD 0.03 (-0.34, 0.40)], the long-term postoperative VAS scores between them [P > 0.05, WMD 0.01 (-0.42, 0.45)] and the short-term postoperative ODI [P > 0.05, WMD -0.33 (-2.36, 1.69)] between the two groups. The unilateral approaches required significantly less dosage of PMMA than the bipedicular approaches did [P < 0.05, WMD -1.56 (-1.59, -1.16)]. The restoration rate in the bilateral groups was higher than the unilateral groups [P < 0.05, WMD -7.82 (-12.23, -3.41)]. There was no significant difference in the risk ratio of cement leakage [P > 0.05, RR 0.86 (0.36, 2.06)] and postoperative adjacent-level fractures [P > 0.05, RR 0.91 (0.25, 3.26)] between the two methods. The mean X-ray exposure frequency in the unilateral groups was greater than the bilateral groups [P < 0.05, WMD -5.69 (-10.67, -0.70)]. CONCLUSIONS: A definitive verdict could not be reached regarding which approach is better for the treatment of OVCF. Although unilateral PKP was associated with shorter operative time, less X- ray exposure frequency and dosage of PMMA than bilateral PKP. There was no apparent difference in the short- and long-term clinical outcomes and complications between them. However, bilateral PKP approaches were higher than unilateral PKP in term of the restoration rate. But on account of lack of some high-quality evidence, we hold that amounts of high-quality randomized controlled trials should be required and more complications should be analysed to resolve which surgical approach is better for the treatment of OVCF in the future.

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.

Kyphoplasty vs conservative treatment: a case-control study in 110 post-menopausal women population. Is kyphoplasty better than conservative treatment?

OBJECTIVE: Osteoporosis is a highly prevalent disease worldwide. Consequences of vertebral osteoporotic fractures include pain and progressive vertebral collapse resulting in spinal kyphosis, decreased quality of life, disability and mortality. Minimally invasive procedures represent an advance to the treatment of osteoporotic VCFs. Despite encouraging results reported by many authors, surgical intervention in an osteoporotic spine is fraught with difficulties. Advanced patients age and comorbidities are of great concern. PATIENTS AND METHODS: We designed a retrospective case-control study on 110 post-menopausal women consecutively visited at our institution. Study population was split in a surgical and a conservative cohort, according to the provided treatment. RESULTS: Kyphoplasty treated patients had lower back pain VAS scores at 1 month as compared with conservatively treated patients (p < 0.05). EQ5D validated questionnaire also showed a better quality of life at 1 month for surgically treated patients (p < 0.05). SF-12 scores showed greater improvements at 1 month and 3 months with statistically significant difference between the two groups just at 3 months (p < 0.05). At 12 months, scores from all scales were not statistically different between the two cohorts, although surgically treated patients showed better trends than conservatively treated patients in pain and quality of life. Kyphoplasty was able to restore more than 54.55% of the original segmental kyphosis, whereas patients in conservative cohort lost 6.67% of the original segmental kyphosis on average. CONCLUSIONS: Kyphoplasty is a modern minimal invasive surgery, allowing faster recovery than bracing treatment. It can avoid the deformity in kyphosis due to VCF. In fact, the risk to develop a new vertebral fracture after the first one is very high.

Unilateral versus bilateral percutaneous kyphoplasty for osteoporotic vertebral compression fractures: A systematic review and meta-analysis of RCTs.

The purpose of this research was to compare the efficacy and safety of unilateral versus bilateral PKP for osteoporotic vertebral compression fractures (OVCFs). Six databases (Cochrane, PubMed, MEDLINE, EMBASE, SinoMed, and CNKI) were searched without language restrictions. Twelve randomized controlled trials involving a total of 1,030 patients were identified. The results indicate that unilateral PKP had a better degree of pain relief (visual analog scale) than bilateral PKP (p = 0.04; 95%CI = -0.36 to -0.00) with short-term follow-up (within 4 weeks) after operation. The radiological outcome assessment with short-term follow-up after operation indicates bilateral PKP had a better degree of anterior vertebral height restoration (p = 0.03; 95%CI = -2.58 to -0.14). Operation time and cement dosage were less for unilateral PKP (p < 0.05). There were no differences in complications such as cement leakage and adjacent vertebral fractures between two approaches (p = 0.06 and p = 0.97, respectively). Life quality assessment (SF-36) indicates unilateral PKP had a better result of bodily pain relief (p < 0.05; 95%CI = 3.93 to 7.48) and general health benefit (p < 0.05; 95%CI = 0.02 to 2.93) with short-term follow-up after operation. We suggest that a unilateral PKP is advantageous.