Appropriate Management of Vertebral Fragility Fractures: Development of a Pathway Based on a Vertebral Compression Fracture Registry.

BACKGROUND: The BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments. OBJECTIVES: The purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry. STUDY DESIGN: Prospective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure. SETTING: The VCF Registry is a national ongoing registry with no specified end time or designated sample size. METHODS: Primary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death. RESULTS: The VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation. LIMITATIONS: The nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings. CONCLUSIONS: Cement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population. KEY WORDS: Vertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.

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.

The evidentiary basis of vertebral augmentation: a 2019 update.

No aspect of neurointerventional practice has been associated with as longstanding contention and debate as to its effectiveness as has vertebroplasty (VP). Four blinded randomized controlled trials published since 2009 have demonstrated conflicting results regarding a conferred benefit in pain reduction and functional improvement for patients who undergo VP for osteoporotic vertebral compression fractures. Significant heterogeneity exists between each of these trials, which has resulted in difficulty for interventionalists and surgeons to translate the trial findings into routine clinical practice. In addition, patients and their families are ever more enlightened and enabled via the internet and social media to review both medical literature and websites. Without the proper background and context, their decisions may be lacking appropriate and necessary scientific discussion. This review article summarizes the randomized controlled trial data to date, with particular focus on the aforementioned four blinded studies. We will also evaluate the profound impact of the decrease in vertebral augmentation utilization on short- and long-term patient morbidity and mortality using available national and administrative datasets from both within the USA and internationally. We also consider future trial design to help evaluate this procedure and determine its role in modern neurointerventional practice.

The Safety and Efficacy of CT-Guided, Fluoroscopy-Free Vertebroplasty in Adult Spinal Deformity Surgery.

OBJECTIVE: The goal of this study is to analyze the safety and efficacy of a novel technique of computed tomography-guided, fluoroscopy-free vertebroplasty as an adjunct to help prevent proximal junction kyphosis (PJK) in long-segment posterior spinal fusions. METHODS: We performed a retrospective analysis of 118 consecutive patients with adult spinal deformity who underwent long-segment fusion with vertebroplasty augmentation from 2013-2016 at a single institution. For each patient, we collected demographics, surgical information, length of stay, discharge disposition, and complications, including reoperation, PJK, and PJK requiring reoperation. We reviewed all postoperative radiographs to assess for cement leakage from vertebroplasty. These patients were compared to a historical control of 253 patients who underwent adult spinal deformity surgery without vertebroplasty augmentation. RESULTS: The PJK rate of 14% and the PJK requiring reoperation rate of 3% in the cohort of 118 patients who underwent vertebroplasty-augmented fusion was significantly lower than that of the 253 historical controls at our institution who did not undergo vertebroplasty (40% PJK rate, 17% PJK-rate requiring reoperation; both P < 0.001). After controlling for patient and other surgical factors in multivariate analyses, vertebroplasty was significantly associated with lower rates of PJK and PJK requiring reoperation (P < 0.001 and P = 0.003). CONCLUSIONS: Our novel vertebroplasty technique is safe, and it eliminates the need for additional fluoroscopy in cases already using the O-arm to verify screw placement. In addition, it is an effective technique for reducing PJK in adult spinal deformity surgery compared with historical institutional controls.

An overview of clinical guidelines for the management of vertebral compression fracture: a systematic review.

BACKGROUND CONTEXT: Vertebral compression fractures (VCFs) are the most common type of osteoporotic fracture comprising approximately 1.4 million cases worldwide. Clinical practice guidelines can be powerful tools for promoting evidence-based practice as they integrate research findings to support decision making. However, currently available clinical guidelines and recommendations, established by different medical societies, are sometimes contradictory. PURPOSE: The aim of this study was to appraise the recommendations and the methodological quality of international clinical guidelines for the management of VCFs. STUDY DESIGN: This is a systematic review of clinical guidelines for the management of VCF. METHODS: Guidelines were selected by searching MEDLINE and PubMed, PEDro, CINAHL, and EMBASE electronic databases between 2010 and 2016. We also searched clinical practice guideline databases, including the National Guideline Clearinghouse and the Canadian Medical Association InfoBase. The methodological quality of the guidelines was assessed by two authors independently using the Appraisal of Guidelines, Research and Evaluation (AGREE) II Instrument. We also classified the strength of each recommendation as either strong (ie, based on high-quality studies with consistent findings for recommending for or against the intervention), weak (ie, based on a lack of compelling evidence resulting in uncertainty for benefit or potential harm), or expert consensus (ie, based on expert opinion of the working group rather than on scientific evidence). Guideline recommendations were grouped into diagnostic, conservative care, interventional care, and osteoporosis treatment and prevention of future fractures. Our study was prospectively registered on PROSPERO. RESULTS: Four guidelines from three countries, published in the period 2010-2013, were included. In general, the quality was not satisfactory (50% or less of the maximum possible score). The domains scoring 50% or less of the maximum possible score were rigor of development, clarity of presentation, and applicability. The use of plain radiography or dual-energy X-ray absorptiometry for diagnosis was recommended in two of the four guidelines. Vertebroplasty or kyphoplasty was recommended in three of the four guidelines. The recommendation for bed rest, trunk orthoses, electrical stimulation, and supervised or unsupervised exercise was inconsistent across the included guidelines. CONCLUSIONS: The comparison of clinical guidelines for the management of VCF showed that diagnostic and therapeutic recommendations were generally inconsistent. The evidence available to guideline developers was limited in quantity and quality. Greater efforts are needed to improve the quality of the majority of guidelines.

Standardized Reporting in IR: A Prospective Multi-Institutional Pilot Study.

PURPOSE: To assess adoption and survey-based satisfaction rates following deployment of standardized interventional radiology (IR) procedure reports across multiple institutions. MATERIALS AND METHODS: Standardized reporting templates for 5 common interventional procedures (central venous access, inferior vena cava [IVC] filter insertion, IVC filter removal, uterine artery embolization, and vertebral augmentation) were distributed to 20 IR practices in a prospective quality-improvement study. Participating sites edited the reports according to institutional preferences and deployed them for a 1-year pilot study concluding in July 2015. Study compliance was measured by sampling 20 reports of each procedure type at each institution, and surveys of interventionalists and referring physicians were performed. Modifications to the standardized reporting templates at each site were analyzed. RESULTS: Ten institutions deployed the standardized reports, with 8 achieving deployment of 3-12 months. The mean report usage rate was 57%. Each site modified the original reports, with 26% mean reduction in length, 18% mean reduction in wordiness, and 60% mean reduction in the number of forced fill-in fields requiring user input. Linear-regression analysis revealed that reduced number of forced fill-in fields correlated significantly with increased usage rate (R2 = 0.444; P = .05). Surveys revealed high satisfaction rates among referring physicians but lower satisfaction rates among interventional radiologists. CONCLUSIONS: Standardized report adoption rates increased when reports were simplified by reducing the number of forced fill-in fields. Referring physicians preferred the standardized reports, whereas interventional radiologists preferred standard narrative reports.

[Kyphoplasty and vertebroplasty for spinal trauma]. / Kyphoplastie und Vertebroplastie bei Wirbelsäulentraumata.

CLINICAL ISSUE: Minimally invasive treatment of spinal fractures. STANDARD TREATMENT PROCEDURES: Conservative treatment versus spinal surgery. TREATMENT INNOVATIONS: Minimally invasive stabilization techniques, such as percutaneous (assisted) cementoplasty have been introduced as new procedures. DIAGNOSTIC WORK-UP: Magnetic resonance imaging (MRI), X­rays and computed tomography (CT) are the imaging techniques of first choice. The most important questions concern recent fractures, instability and indications for minimally invasive treatment. PERFORMANCE: Vertebroplasty and kyphoplasty are established methods for the treatment of patients with osteoporosis. ACHIEVEMENTS: Cementoplasty techniques are promising treatment options for traumatic spinal injuries. PRACTICAL RECOMMENDATIONS: The application of the techniques should best be carried out in individual cases within the framework of prospective controlled studies.

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.

Effect of Augmentation Material Stiffness on Adjacent Vertebrae after Osteoporotic Vertebroplasty Using Finite Element Analysis with Different Loading Methods.

BACKGROUND: Vertebroplasty is an effective treatment for osteoporotic vertebral fractures, which are one of the most common fractures associated with osteoporosis. However, clinical observation has shown that the risk of adjacent vertebral body fractures may increase after vertebroplasty. The mechanism underlying adjacent vertebral body fracture after vertebroplasty is not clear; excessive stiffness resulting from polymethyl methacrylate has been suspected as an important mechanism. OBJECTIVES: The aim of our study was to compare the effects of bone cement stiffness on adjacent vertebrae after osteoporotic vertebroplasty under load-controlled versus displacement-controlled conditions. STUDY DESIGN: An experimental computer study using a finite element analysis. SETTING: Medical research institute, university hospital, Korean. METHODS: A three-dimensional digital anatomic model of L1/2 bone structure was reconstructed from human computed tomographic images. The reconstructed three-dimensional geometry was processed for finite element analysis such as meshing elements and applying material properties. Two boundary conditions, load-controlled and displacement-controlled methods, were applied to each of 5 deformation modes: compression, flexion, extension, lateral bending, and torsion. RESULTS: The adjacent L1 vertebra, irrespective of augmentation, revealed nearly similar maximum von Mises stresses under the load-controlled condition. However, for the displacement-controlled condition, the maximum von Mises stresses in the cortical bone and inferior endplate of the adjacent L1 vertebra increased significantly after cement augmentation. This increase was more significant than that with stiffer bone cement under all modes, except the torsion mode. LIMITATIONS: The finite element model was simplified, excluding muscular forces and incorporating a large volume of bone cement, to more clearly demonstrate effects of bone cement stiffness on adjacent vertebrae after vertebroplasty. CONCLUSION: Excessive stiffness of augmented bone cement increases the risk of adjacent vertebral fractures after vertebroplasty in an osteoporotic finite element model. This result was most prominently observed using the displacement-controlled method.

Comparison of high-viscosity cement vertebroplasty and balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures.

BACKGROUND: Percutaneous vertebroplasty is a widely used vertebral augmentation procedure for treating osteoporotic vertebral compression fractures (OVCFs). But high cement leakage rate caused by a low-viscosity cement and high injection pressure has limited its general use. Balloon kyphoplasty (BKP) and high-viscosity cement vertebroplasty (HVCV) are 2 modifications of vertebroplasty designed to decrease cement leakage. OBJECTIVE: To assess the safety and efficacy of HVCV compared with BKP. STUDY DESIGN: A prospective cohort study. SETTING: Department of Spine Surgery, an affiliated hospital of a medical university. METHOD: One hundred seven patients suffering from painful OVCFs were randomly assigned into HVCV or BKP groups. Visual Analog Scale (VAS), Oswestry Disability Index (ODI), cement leakage, and vertebral height restoration were evaluated. All occurring complications and injected cement volumes were recorded. The follow-up time was one year. RESULTS: VAS and ODI scores improved in both groups, and did not differ significantly between the 2 groups. More cement was used in the BKP group than in HVCV group (4.22 vs. 3.31 mL, P < 0.0001). The incidence of cement leakage in the HVCV group was lower than that of the BKP group (13.24% vs 30.56%, P < 0.05). No symptomatic cement leakages occurred in the HVCV group. In the BKP group, one patient experienced discogenic back pain related to a disc leak, and another patient had asymptomatic cement emboli in the lung related to venous leakage. The mean compression rate before the procedure was 29.98% in the HVCV group and 28.67% in the BKP group (P = 0.94). The vertebral height was improved significantly and maintained at one-year follow-up in both groups. BKP was more effective in vertebral height restoration than HVCV (44.87% vs. 23.93%, P < 0.0001). There was one case of a new adjacent vertebral fracture in the HVCV group (2%), and 4 cases of new nonadjacent vertebral fractures in the BKP group (7.84%) (P = 0.18). LIMITATIONS: A single-center and relatively small-sample size study. CONCLUSION: HVCV and BKP are safe and effective in improving quality of life and relieving pain. HVCV has a lower cement leakage rate, whereas BKP is more effective in vertebral height restoration. Subsequent fractures are not different between the 2 groups.

Is balloon kyphoplasty better than percutaneous vertebroplasty for osteoporotic vertebral biconcave-shaped fractures?

BACKGROUND: Osteoporotic vertebral biconcave-shaped fractures are not commonly seen in clinical practice. Some articles have been published showing the outcome of vertebroplasty (PV) and balloon kyphoplasty (BKP), but few comparative studies have been performed. PURPOSE: To compare the effect and safety of PV and BKP in treating osteoporotic vertebral biconcave-shaped fractures. MATERIAL AND METHODS: In this retrospective comparative study, 38 patients with osteoporotic vertebral biconcave-shaped fractures were treated by PV, and 41 patients were treated by BKP from May 2005 to July 2011. The heights of the compromised vertebral body and the kyphotic angles were measured. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) were used to evaluate pain and functional activity, respectively. The occurrence of refracture and cement leakage were determined, and the costs were recorded. RESULTS: The mean VAS and ODI scores significantly improved for both procedures at postsurgical measurements (P < 0.05), and the improvement sustained at the final follow-up. In both groups, there were no significant differences in terms of restoration of the anterior vertebral height and correction of the kyphotic deformity. However, BKP was more effective in restoring the middle vertebral height than PV. Cement leakages were observed in nine (23.7%) treated vertebral bodies in PV group and in three (7.4%) treated vertebral bodies in BKP group, which was a statistically significant difference (P < 0.05). There were four new osteoporotic vertebral fractures in the PV group and two in the BKP group during the follow-up period. The mean cost in the BKP group (6200 ± 122.1 USD) was higher than the PV group (2100 ± 112.5 USD) (P < 0.05). CONCLUSION: Both PV and BKP achieved similar improvements in pain and functional outcomes for the treatment of osteoporotic vertebral biconcave-shaped fractures. BKP had a significant advantage over PV in terms of the restoration of the middle vertebral height and fewer cement leakages than PV.

Single centre prospective study of the efficacy of percutaneous cement augmentation in the treatment of vertebral compression fractures.

INTRODUCTION: Despite controversial outcomes of recent published trials, percutaneous cement augmentation remains widely used in managing painful vertebral compression fractures. We prospectively assessed patients with such fractures using an eleven-point visual analogue scale for pain and the Qualeffo 41 questionnaire for quality of life. METHODS: Consecutive patients undergoing percutaneous cement augmentation for painful vertebral compression fractures were recruited. Patients were assessed pre-procedure by completing a visual analogue scale for pain, on a scale of 0 to 10. A Qualeffo 41 questionnaire was also completed. Patients were followed up at 1 week and 3 months. RESULTS: Fifty six patients were prospectively recruited (111 vertebroplasty and 5 kyphoplasty). Visual analogue scores dropped from 6.4 ± 2.3 pre-procedure to 4.0 ± 2.7 at 1 week (p < 0.0001) and 4.3 ± 2.7 (p < 0.0001) at 3 months. Three subgroups were identified; osteoporotic patients (n = 28), a second non-osteoporotic group (n = 20) who had acute fracture following fall and a third group with compression fractures secondary to metastatic disease (n = 8). At 3-month follow-up, patients with osteoporotic fractures had reduction in pain score from 6.3 ± 2.1 to 4.8 ± 2.7 (p = 0.02). Patients who had traumatic fractures experienced more significant pain relief, 6.4 ± 2.6 to 3.8 ± 2.7 (p = 0.0009) but patients with malignant fracture had most benefit, 6.0 ± 3.0 to 1.8 ± 0.8 (p = 0.01). Total Qualeffo scores improved from 63 ± 15 to 49 ± 22 (p < 0.0001). Within the domains of the Qualeffo questionnaire, most improvement was seen in pain and physical function. Median in-patient stay post procedure was one day. CONCLUSION: In our experience percutaneous cement augmentation is safe and efficacious in the management of painful VCF related to osteoporosis, trauma and cancer, achieving rapid and significant pain reduction and improvement in physical function as measured with a visual analogue scale and the Qualeffo 41 questionnaire.

Percutaneous spinal fixation simulation with virtual reality and haptics.

BACKGROUND: In this study, we evaluated the use of a part-task simulator with 3-dimensional and haptic feedback as a training tool for percutaneous spinal needle placement. OBJECTIVE: To evaluate the learning effectiveness in terms of entry point/target point accuracy of percutaneous spinal needle placement on a high-performance augmented-reality and haptic technology workstation with the ability to control the duration of computer-simulated fluoroscopic exposure, thereby simulating an actual situation. METHODS: Sixty-three fellows and residents performed needle placement on the simulator. A virtual needle was percutaneously inserted into a virtual patient's thoracic spine derived from an actual patient computed tomography data set. RESULTS: Ten of 126 needle placement attempts by 63 participants ended in failure for a failure rate of 7.93%. From all 126 needle insertions, the average error (15.69 vs 13.91), average fluoroscopy exposure (4.6 vs 3.92), and average individual performance score (32.39 vs 30.71) improved from the first to the second attempt. Performance accuracy yielded P = .04 from a 2-sample t test in which the rejected null hypothesis assumes no improvement in performance accuracy from the first to second attempt in the test session. CONCLUSION: The experiments showed evidence (P = .04) of performance accuracy improvement from the first to the second percutaneous needle placement attempt. This result, combined with previous learning retention and/or face validity results of using the simulator for open thoracic pedicle screw placement and ventriculostomy catheter placement, supports the efficacy of augmented reality and haptics simulation as a learning tool.

A cadaver study to compare vertebral augmentation with a high-viscosity cement to augmentation with conventional lower-viscosity cement.

STUDY DESIGN: Comparison of extravasations in fractured cadaver vertebrae augmented with commercial low-viscosity versus high-viscosity cements. OBJECTIVE: Use of high-resolution, 3-dimensional (3D) imaging to test the hypothesis that high-viscosity cements can reduce the type and severity of extravasations after vertebral augmentation procedures. SUMMARY OF BACKGROUND DATA: Cement extravasations are one of the primary complications of vertebral augmentation procedures. There is some evidence that high-viscosity cements might reduce extravasations, but additional data are needed to confirm the early findings. METHODS: A range of vertebral fractures were created in fresh human cadavers. One group was then augmented with a low-viscosity polymethylmethacrylate (PMMA)-based cement and the other group injected with high-viscosity PMMA-based cement. High-resolution computerized tomography exams were obtained, and extravasations were assessed using 3D volume renderings. The type and severity of extravasations were recorded and analyzed. RESULTS: The proportion of vertebrae with any type of extravasation through the posterior wall to the spinal canal, into small vessels laterally or anteriorly, through the endplates, or anywhere around the body was not significantly different between the high-viscosity and low-viscosity groups. There was significantly less severe extravasation through the endplates (P=0.02), and a trend toward less severe extravasation through vessels (P=0.06) with the high versus low-viscosity cements. CONCLUSIONS: In agreement with previous research, high-viscosity PMMA-based cement may help to reduce the more severe forms of extravasations after vertebral augmentation procedures in newly fractured vertebrae.

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

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