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.

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.

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.

Is additional balloon Kyphoplasty safe and effective for acute thoracolumbar burst fracture?

BACKGROUND: Burst fracture is a common thoracolumbar injury that is treated using posterior pedicle instrumentation and fusion combined with transpedicular intracorporeal grafting after reduction. In this study, we compared the outcome of these two techniques by using radiologic imaging and functional outcome. METHODS: Sixty-one patients with acute thoracolumbar burst fracture were operated with kyphoplasty (n = 31) or vertebroplasty (n = 30) and retrospectively reviewed in our institution between 2011 and 2014. All 61 patients underwent surgery within 5 days after admission to the hospital and then followed-up for 12 to 24 months after surgery. RESULTS: Significant improvement was found in the anterior vertebral height (92 ± 8.9% in the kyphoplasty group, 85.6 ± 7.2% in the vertebroplasty group, p < 0.01) at 1 month post-operatively and (89 ± 7.9% in the kyphoplasty group, 78 ± 6.9% in the vertebroplasty group, p < 0.01) at the 24-month follow-up. Significant improvement was also observed in the kyphotic angle (1.2 ± 0.5° in the kyphoplasty group, 10.5 ± 1.2° in the vertebroplasty group, p < 0.01) at 1 month post-operatively and (5.4 ± 1.2° in the kyphoplasty group, 11.5 ± 8.5° in the vertebroplasty group, p < 0.01) at the 24-month follow-up. Both operations led to significant improvement of the patients' pain and the Oswestry disability index (p < 0.01). Cement leakage was noted in 29% of patients after kyphoplasty and 77% of patients after vertebroplasty (p < 0.01). Only one implant failure (3.3%), which required further surgical intervention, was reported in the vertebroplasty group. CONCLUSIONS: Reduction with additional balloon at the fractured site is better than indirect reduction only by posterior instrumentation. The better reduction of kyphotic angle and the lower cement leakage rate in the kyphoplasty group indicate that additional balloon kyphoplasty is safe and effective for acute thoracolumbar burst fracture.

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.

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.

Efficacy and safety of vertebral stenting for painful vertebral compression fractures in patients with metastatic disease.

BACKGROUND AND PURPOSE: Painful vertebral compression fractures in cancer patients reduce quality of life and may limit survival. We assessed pain relief, vertebral height restoration, and kyphosis correction following vertebral augmentation using a novel expandable titanium stent implant in cancer patients with painful vertebral compression fractures. MATERIALS AND METHODS: Patients >18 years of age with metastatic disease who presented symptomatic compression fractures of vertebral bodies T5-L5, with or without a history of osteoporosis, were included in the study. Back pain at presentation, immediately after vertebral stenting, and at 1-, 3-, 6-, and 12-month follow-up was estimated using the visual analog scale (VAS). Vertebral height and local kyphotic angle (alpha angle) were measured on lateral standing X-ray before and 1-3 months after stenting. RESULTS: Forty-one cancer patients with painful vertebral compression fractures underwent vertebral stenting procedures at 55 levels. There was no perioperative mortality and no significant complication. Median preoperative VAS was 8.0 (range 8-10), falling to 2.0 immediately postop (range 1-6, P  =  0.000) and 0 at all subsequent follow-up (P ≤ 0.012). Mean preoperative vertical height loss was 25.8% (range 0-84.0%) versus a postoperative mean of 18.0% (range 0-66.0%, P  =  0.000). Median pre- and postoperative kyphotic angle improved from 8.3° (range 0.2°-54.0°) to 7.1° (range 0.2°-25.0°, P  =  0.000). Wilcoxon signed rank test or student's t-test was used for comparisons. CONCLUSIONS: Vertebral augmentation using a novel vertebral stenting system provided immediate and enduring pain relief and improved vertebral height loss and kyphotic angle.

Sensitivity analysis for a partially missing binary outcome in a two-arm randomized clinical trial.

Although recent guidelines for dealing with missing data emphasize the need for sensitivity analyses, and such analyses have a long history in statistics, universal recommendations for conducting and displaying these analyses are scarce. We propose graphical displays that help formalize and visualize the results of sensitivity analyses, building upon the idea of 'tipping-point' analysis for randomized experiments with a binary outcome and a dichotomous treatment. The resulting 'enhanced tipping-point displays' are convenient summaries of conclusions obtained from making different modeling assumptions about missingness mechanisms. The primary goal of the displays is to make formal sensitivity analysesmore comprehensible to practitioners, thereby helping them assess the robustness of the experiment's conclusions to plausible missingness mechanisms. We also present a recent example of these enhanced displays in amedical device clinical trial that helped lead to FDA approval.

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.

The correlation between vertebral wedge-shaped changes in X-ray imaging at supine and standing positions and the efficacy of operative treatment of thoracolumbar spinal fracture in the elderly.

STUDY DESIGN: By analyzing a large number of surgical patients, we identified the roles of wedge-shaped changes in related surgeries. OBJECTIVES: To illustrate the relevance of vertebral wedge-shaped changes in X-ray imaging at supine and standing positions in patients with percutaneous kyphoplasty as well as the postoperative effect. SETTING: All patient data were collected from a hospital in China. METHODS: Between June 2006 and May 2010, 77 surgical patients (9 men and 68 women) with wedge-shaped compression fractures were retrospectively analyzed. Patients were divided into group A (ΔWR2.5%) and group B (ΔWR<2.5%) according to the dynamic changes in the percentage of vertebral body wedge-shaped variable ratio (WR) at supine and standing positions. The intensity of back pain in different positions pre- and postoperatively was evaluated with a visual analog pain scale (VAS). RESULTS: The WRs in both standing and supine positions were significantly reduced by kyphoplasty in both groups A and B. In agreement with the improvement in WRs, the VAS was significantly decreased in three positions for patients in group A and in turning over and standing position for patients in group B. With respect to ΔWR changes, group B revealed significantly lower values compared with group A preoperatively (P<0.001), but there was no significant difference between groups A and B postoperatively and at 1-month follow-up (P=0.179 and P=0.558, respectively). CONCLUSIONS: Improvement in symptoms after kyphoplasty is better in patients with wedge-shaped changes in supine and standing positions, and the efficacy of height restoration of the spine would be better in unstable vertebrae by balloon dilatation.

An evaluation of fracture stabilization comparing kyphoplasty and titanium mesh repair techniques for vertebral compression fractures: is bone cement necessary?

STUDY DESIGN: In vitro biomechanical investigation using human cadaveric vertebral bodies. OBJECTIVE: To evaluate differences in biomechanical stability of vertebral compression fractures (VCFs) repaired using an expandable titanium mesh implant, with and without cement, as compared with standard balloon kyphoplasty. SUMMARY OF BACKGROUND DATA: Vertebral augmentation, either in the form of vertebroplasty or kyphoplasty, is the treatment of choice for some VCFs. Polymethylmethacrylate, a common bone cement used in this procedure, has been shown to possibly cause injury to neural and vascular structures due to extravasation, embolization, and may be too rigid for an osteoporotic spine. Therefore, suitable alternatives for the treatment of VCFs have been sought. METHODS: Individual vertebral bodies from 5 human cadaveric spines (from T4 to L5) were stripped of all soft tissues, and compressed at 25% of the intact height using methods previously described. Vertebral bodies were then randomly assigned to the following repair techniques: (1) conventional kyphoplasty, (2) titanium implant with cement, (3) titanium implant without cement. All vertebral bodies were then recompressed at 25% of the repaired height. Yield load, ultimate load, and stiffness were recorded and compared in these groups before and after treatment. RESULTS: There were no differences in biomechanical data between intact groups, and between repaired groups. In all 3 treatment groups, yield load and ultimate load of repaired vertebrae were similar to that of intact vertebrae. However, the stiffness following repair was found to be statistically less than the stiffness of the intact vertebral body (P < 0.05 for all comparisons). CONCLUSION: Based on the biomechanical data, the titanium mesh implant with or without cement was similar to polymethylmethacrylate fixation by kyphoplasty in the treatment of VCFs. Avoiding the adverse effects caused by using cement may be the main advantage of the titanium mesh implant and warrants further study.