Intraoperative pain prediction of percutaneous kyphoplasty under local anesthesia by preoperative experimental pain assessment.

BACKGROUND: Percutaneous kyphoplasty (PKP) is the preferred treatment for osteoporotic vertebral compression fractures (OVCF) Currently, the preoperative anesthesia methods for PKP are mainly local anesthesia and tracheal intubation general anesthesia. OBJECTIVE: To assess whether patient sensitivity to pain measured preoperatively could predict the patients' pain response during PKP treatment under local anesthesia, to facilitate the development of an optimal preoperative anesthesia plan for patients. METHODS: Fifty-five female patients diagnosed with osteoporotic single vertebral fracture who were treated with PKP under local anesthesia were selected. The patients' pain sensitivities, including pain threshold and pain tolerance threshold, were evaluated with a pain test device on the day before the operation in the ward. Heart rate (HR), mean arterial pressure (MAP), and blood oxygen saturation (SpO2) were recorded before anesthesia, post-anesthesia, after needle puncture, and after balloon dilatation. At the same time, blood was drawn at the above time points to determine the level of norepinephrine (NA) as an indicator of intraoperative pain stress response. The numerical rating scale (NRS) during surgery was recorded at the end of the surgery. RESULTS: The preoperative pain tolerance threshold of 55 surgical patients was correlated with the intraoperative NRS score (r=-0.768, P< 0.001), as well as with the preoperative and intraoperative changes in HR (r=-0.791, P< 0.001), MAP (r=-0.819, P< 0.001), and NA (r=-0.553, P< 0.001). Thus, the lower the preoperative pain tolerance threshold, the more severe the patient's response to pain during PKP treatment under local anesthesia, and the greater the hemodynamic changes. Consequently, the intraoperative experience becomes worse. However, there was no correlation between preoperative pain threshold and NRS scores (r=-0.069, P= 0.616) nor between the preoperative and intraoperative changes in HR (r= 0.103, P= 0.453), MAP (r= 0.086, P= 0.535), and NA (r=-0.058, P= 0.674). CONCLUSION: The results indicated that preoperative pain assessment could predict the level of pain response in OVCF patients during PKP surgery under local anesthesia.

Analysis of Long-Term Medical Expenses in Vertebral Fracture Patients.

Background: The objective of this study was to analyze the direct medical expenses of a vertebral fracture cohort (VC) and a matched cohort (MC) over 5 years preceding and following the fracture, analyze the duration of the rise in medical expenses due to the fracture, and examine whether the expenses vary with age group, utilizing a national claims database. Methods: Subjects with vertebral fractures and matched subjects were chosen from the National Health Insurance Service Sample cohort (NHIS-Sample) of South Korea. Patients with vertebral fractures were either primarily admitted to acute care hospitals (index admissions) or those who received kyphoplasty or vertebroplasty during the follow-up period (2002-2015). A risk-set matching was performed using 1 : 5 random sampling to simulate a real-world situation. Individual-level direct medical expenses per quarter were calculated for 5 years prior and subsequent to the vertebral fracture. In this analysis using a comparative interrupted time series design, we examined the direct medical expenses of a VC and an MC. Results: A total of 3,923 incident vertebral fracture patients and 19,615 matched subjects were included in this study. The mean age was 75.5 ± 7.4 years, and 69.5% were women. The mean difference in medical expenses between the two groups increased steadily before the fracture. The medical expenses of the VC peaked in the first quarter following the fracture. The cost changes were 1.82 times higher for the VC than for the MC (95% confidence interval, 1.62-2.04; p < 0.001) in the first year. Subsequently, there were no differential changes in medical expenses between the two groups (p > 0.05). In the < 70-year subgroup, there were no differential changes in medical expenses between the two groups (p > 0.05). However, in the ≥ 80-year subgroup, the cost changes for the VC were higher than those for the MC up to 5 years after time zero. Conclusions: Based on our study results, we suggest that health and medical policies for vertebral fractures should be designed to last up to approximately 1 year after the fracture. Health policies should be differentiated according to age group.

MRI-based radiomics assessment of the imminent new vertebral fracture after vertebral augmentation.

BACKGROUND: Imminent new vertebral fracture (NVF) is highly prevalent after vertebral augmentation (VA). An accurate assessment of the imminent risk of NVF could help to develop prompt treatment strategies. PURPOSE: To develop and validate predictive models that integrated the radiomic features and clinical risk factors based on machine learning algorithms to evaluate the imminent risk of NVF. MATERIALS AND METHODS: In this retrospective study, a total of 168 patients with painful osteoporotic vertebral compression fractures treated with VA were evaluated. Radiomic features of L1 vertebrae based on lumbar T2-weighted images were obtained. Univariate and LASSO-regression analyses were applied to select the optimal features and construct radiomic signature. The radiomic signature and clinical signature were integrated to develop a predictive model by using machine learning algorithms including LR, RF, SVM, and XGBoost. Receiver operating characteristic curve and calibration curve analyses were used to evaluate the predictive performance of the models. RESULTS: The radiomic-XGBoost model with the highest AUC of 0.93 of the training cohort and 0.9 of the test cohort among the machine learning algorithms. The combined-XGBoost model with the best performance with an AUC of 0.9 in the training cohort and 0.9 in the test cohort. The radiomic-XGBoost model and combined-XGBoost model achieved better performance to assess the imminent risk of NVF than that of the clinical risk factors alone (p < 0.05). CONCLUSION: Radiomic and machine learning modeling based on T2W images of preoperative lumbar MRI had an excellent ability to evaluate the imminent risk of NVF after VA.

Risk assessment for sandwich vertebral fractures in the treatment of osteoporosis vertebral compression fractures using two methods of bone cement reinforcement.

PURPOSE: Bone cement augmentation surgery includes percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP). In this study, we aimed to investigate the risk of sandwich vertebral fractures in the treatment of osteoporotic vertebral compression fractures via PVP and PKP. METHODS: We performed a retrospective analytical study and included 61 patients with osteoporotic vertebral compression fractures who underwent PVP and PKP at the Spinal Surgery Department of The Second Hospital of Liaocheng Affiliated with Shandong First Medical University from January 2019 to January 2022. These patients were divided into the following two groups by simple random sampling: group A (N = 30) underwent PVP treatment and group B (N = 31) underwent PKP treatment. The surgical time, fluoroscopy frequency, visual analog scale (VAS) score, amount of bone cement, the leakage rate of bone cement in intervertebral space, Cobb angle, and the incidence of fractures in both groups of sandwich vertebral were recorded after 1 year of follow-up. RESULTS: No statistically significant difference was found in terms of surgical time, fluoroscopy frequency, and VAS score between the two groups (P > 0.05). However, a statistically significant difference was found in terms of the amount of bone cement, the leakage rate of bone cement intervertebral space, Cobb angle, and the incidence of vertebral body fractures in both groups (P < 0.05). The amount of bone cement, the leakage rate of bone cement in intervertebral space, Cobb angle, and sandwich vertebral fractures were higher in Group A than in Group B. CONCLUSIONS: When PVP and PKP were performed to treat osteoporotic vertebral compression fractures, the sandwich vertebral exhibited a risk of fracture. PVP exhibited a greater relative risk than PKP, which may be due to the relatively larger amount of bone cement, higher rate of bone cement leakage in the intervertebral space, and larger Cobb angle.

Mortality among older adults with osteoporotic vertebral fracture.

We evaluated whether older adults who received kyphoplasty had reduced risk of mortality compared to those who did not. In unmatched analyses, those receiving kyphoplasty were at reduced risk of death but after matching on age and medical complications, patients who received kyphoplasty were at increased risk of death. PURPOSE: In previous observational studies, kyphoplasty for treatment of osteoporotic vertebral fractures has been associated with decreased mortality compared to conservative management. The purpose of this research was to determine whether older adults who received kyphoplasty had reduced risk of mortality compared to matched patients who did not. METHODS: Retrospective cohort study of US Medicare enrollees with osteoporotic vertebral fractures between 2017-2019 comparing patients who underwent kyphoplasty to those who did not. We identified 2 control groups a priori: 1) non-augmented patients who met inclusion criteria (group 1); 2) propensity-matched patients on demographic and clinical variables (group 2). We then identified additional control groups using matching for medical complications (group 3) and age + comorbidities (group 4). We calculated hazard ratios (HRs) and 95% confidence intervals (95% CIs) associated with mortality. RESULTS: A total of 235,317 patients (mean (± standard deviation) age 81.1 ± 8.3 years; 85.8% female) were analyzed. In the primary analyses, those who received kyphoplasty were at reduced risk of death compared to those who did not: adjusted HR (95% CI) in group 1 = 0.84 (0.82, 0.87); and in group 2 = 0.88 (0.85, 0.91). However, in post hoc analyses, patients who received kyphoplasty were at increased risk of death: adjusted HR (95% CI) in group 3 = 1.32 (1.25, 1.41) and 1.81 (1.58, 2.09) in group 4. CONCLUSION: An apparent benefit of kyphoplasty on mortality among patients with vertebral fractures was not present after rigorous propensity matching, illustrating the importance of comparing similar individuals when evaluating observational data.

Benign vs malignant vertebral compression fractures with MRI: a comparison between automatic deep learning network and radiologist's assessment.

OBJECTIVE: To test the diagnostic performance of a deep-learning Two-Stream Compare and Contrast Network (TSCCN) model for differentiating benign and malignant vertebral compression fractures (VCFs) based on MRI. METHODS: We tested a deep-learning system in 123 benign and 86 malignant VCFs. The median sagittal T1-weighted images (T1WI), T2-weighted images with fat suppression (T2WI-FS), and a combination of both (thereafter, T1WI/T2WI-FS) were used to validate TSCCN. The receiver operator characteristic (ROC) curve was analyzed to evaluate the performance of TSCCN. The accuracy, sensitivity, and specificity of TSCCN in differentiating benign and malignant VCFs were calculated and compared with radiologists' assessments. Intraclass correlation coefficients (ICCs) were tested to find intra- and inter-observer agreement of radiologists in differentiating malignant from benign VCFs. RESULTS: The AUC of the ROC plots of TSCCN according to T1WI, T2WI-FS, and T1WI/T2WI-FS images were 99.2%, 91.7%, and 98.2%, respectively. The accuracy of T1W, T2WI-FS, and T1W/T2WI-FS based on TSCCN was 95.2%, 90.4%, and 96.2%, respectively, greater than that achieved by radiologists. Further, the specificity of T1W, T2WI-FS, and T1W/T2WI-FS based on TSCCN was higher at 98.4%, 94.3%, and 99.2% than that achieved by radiologists. The intra- and inter-observer agreements of radiologists were 0.79-0.85 and 0.79-0.80 for T1WI, 0.65-0.72 and 0.70-0.74 for T2WI-FS, and 0.83-0.88 and 0.83-0.84 for T1WI/T2WI-FS. CONCLUSION: The TSCCN model showed better diagnostic performance than radiologists for automatically identifying benign or malignant VCFs, and is a potentially helpful tool for future clinical application. CLINICAL RELEVANCE STATEMENT: TSCCN-assisted MRI has shown superior performance in distinguishing benign and malignant vertebral compression fractures compared to radiologists. This technology has the value to enhance diagnostic accuracy, sensitivity, and specificity. Further integration into clinical practice is required to optimize patient management. KEY POINTS: • The Two-Stream Compare and Contrast Network (TSCCN) model showed better diagnostic performance than radiologists for identifying benign vs malignant vertebral compression fractures. • The processing of TSCCN is fast and stable, better than the subjective evaluation by radiologists in diagnosing vertebral compression fractures. • The TSCCN model provides options for developing a fully automated, streamlined artificial intelligence diagnostic tool.

An independent inter- and intra-observer agreement assessment of Yeom classification for bone cement leakage following vertebroplasty/kyphoplasty.

STUDY DESIGN: An inter- and intra-observer agreement study. BACKGROUND: In recent years, vertebroplasty and kyphoplasty have been widely used in treating osteoporotic vertebral compression fractures (OVCF) though the clinical efficacy of them is still controversial. However, there are also inevitable complications, first and foremost is bone cement leakage (BCL). Yeom classification is commonly used to evaluate BCL. The objective of this study is to assess its reliability and reproducibility, and to explore its clinical application value. METHODS: All 58 patients with BCL following vertebroplasty/kyphoplasty were involved. Six spine surgeons were selected to be evaluators as they were unaware of the identity of the patients and the treatment they received. They classified BCL according to Yeom system, we used kappa (K) to assess the inter- and intra-observer agreement. After 12 weeks, we repeated the analysis. RESULTS: The inter-observer reliability of Yeom classification was substantial with K value of 0.71 (1st assessment) and 0.73 (2nd assessment). The intra-observer reproducibility of Yeom classification was near perfect with K value of 0.88. CONCLUSION: Yeom classification system has substantial inter-observer reliability and near perfect intra-observer reproducibility in BCL following vertebroplasty/kyphoplasty, which can be widely used in clinical care as an appropriate instrument for early observation, mechanism and severity cognition, and prognosis predicting of BCL. Besides, the adding of type M (the mixed type) may improve the classification.

Radiographic assessment of acute vs chronic vertebral compression fractures.

PURPOSE: Distinguishing between acute and chronic vertebral compression fractures typically requires advanced imaging techniques such as magnetic resonance imaging (MRI). Recognizing specific radiographic findings associated with fracture acuity may improve the accuracy of radiographic assessment. METHODS: Patients with compression fractures that had both radiographic and MRI studies of the lumbar spine within a 30-day time frame were retrospectively reviewed. MRI studies were used to determine compression fracture acuity. Radiographs were interpreted by a separate group of radiologists blinded to the MRI results. Radiographic findings of endplate osteophyte, subendplate density, subendplate cleft, and subendplate cyst were recorded as was the overall impression of fracture acuity. RESULTS: Sensitivity and specificity for radiographic reporting of acute fracture were 0.52 (95% CI: 0.42, 0.61) and 0.95 (95% CI: 0.93, 0.97) respectively. For chronic fractures, the sensitivity and specificity were 0.52 (95% CI: 0.41, 0.63) and 0.94 (95% CI: 0.92, 0.96). The radiographic presence of a subendplate cleft increased the odds of a fracture being acute by a factor of 1.75 (95% CI: 1.09, 2.81; P = 0.0202). The radiographic presence of subendplate density increased the odds of a fracture being acute by a factor of 1.78 (95% CI: 1.21, 2.63; P = 0.0037). The presence of an endplate osteophyte or subendplate cyst was not significantly associated with fracture acuity. CONCLUSION: Radiographs are relatively insensitive in distinguishing between acute and chronic lumbar compression fractures but the presence of a subendplate cleft or subendplate density increases the likelihood that a given fracture is acute.

Assessment of the Quality of Life of Women after Osteoporotic Vertebral Fracture with Consideration of Socio-Demographic Characteristics and Selected Factors Concerning the State of Health.

Introduction: Fractures of the vertebral bodies are a frequent complication of osteoporosis, hospitalization, decline in physical fitness and, in consequence, deterioration in the quality of life. Objective: The aim of the study was assessment of the quality of life according to the QUALEFFO-41 questionnaire in patients who had undergone fractures of the vertebral bodies, and presentation of the relationships between the quality of life, socio-demographic characteristics, and selected factors concerning the state of health. Materials and Method: The study included 243 women with osteoporotic vertebral fractures, and was conducted in the Outpatient Departments for the Treatment of Osteoporosis in the city of Lublin (eastern Poland). For the purposes of the study, the Quality of Life Questionnaire (QUALEFFO-41) and the author's questionnaire were employed, and Spearman's rank correlation coefficient, t-Student test, and Tukey test were used, along with analysis of variance (ANOVA). The level of statistical significance was set at α = 0.05. Results: The quality of life of woman with vertebral compression fractures remains on a mediocre level. Significant relationships were observed between the respondents' quality of life and certain socio-demographic characteristics, duration of the disease, and complaints related with osteoporosis. Conclusions: It is important to implement appropriate therapy and provide comprehensive, holistic care to women after fractures.

AOSRV: Development and preliminary performance assessment of a new robotic system for autonomous percutaneous vertebroplasty.

BACKGROUND: Percutaneous vertebroplasty (PVP) is one of the most effective treatments for patients with vertebral fracture that need surgical treatment, and surgical robotics are promising tools to provide surgeons with improved precision, surgical efficiency and reduce radiation exposure. However, there are currently few robotics that are developed to help assist with PVP. METHODS: A new spinal surgical robotic system 'AOSRV' for autonomous vertebral puncture and bone cement injection was designed and customised in this study. To investigate its practical abilities and the advantages, we performed single-segment/double-segment PVP simulation surgeries on pig spinal specimens manually and using AOSRV. RESULTS: By contrast with the freehand group (FG) in single-segment (SS)/double-segment (DS) surgery, the robotic group (RG) was superior in the operation time (RGSS = 21.14 ± 4.11 min, FGSS = 33.17 ± 6.83 min; RGDS = 42.39 ± 7.31 min, FGDS = 62.86 ± 20.39 min), puncture adjustments (RGSS = 2.30 ± 1.77, FGSS = 14.86 ± 5.46; RGDS = 3.91 ± 1.76, FGDS = 20.00 ± 7.76), intraoperative fluoroscopies (RGSS = 4.10 ± 1.52, FGSS = 20.57 ± 5.44; RGDS = 7.82 ± 1.40, FGDS = 25.91 ± 7.23) and bone cement leakage rate (RGSS = 30%, FGSS = 71.4%; RGDS = 38.6%, FGDS = 83.3%). CONCLUSIONS: AOSRV was successfully developed and had a promising preliminary performance. An innovative attempt was made for the blank space of the autonomous vertebroplasty surgical robotics, and it may shed a light on more promising applications in the future.

Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Development of a manufacturer-independent convolutional neural network for the automated identification of vertebral compression fractures in vertebral fracture assessment images using active learning.

BACKGROUND: Convolutional neural networks (CNNs) can identify vertebral compression fractures in GE vertebral fracture assessment (VFA) images with high balanced accuracy, but performance against Hologic VFAs is unknown. To obtain good classification performance, supervised machine learning requires balanced and labeled training data. Active learning is an iterative data annotation process with the ability to reduce the cost of labeling medical image data and reduce class imbalance. PURPOSE: To train CNNs to identify vertebral fractures in Hologic VFAs using an active learning approach, and evaluate the ability of CNNs to generalize to both Hologic and GE VFA images. METHODS: VFAs were obtained from the OsteoLaus Study (labeled Hologic Discovery A, n = 2726), the Manitoba Bone Mineral Density Program (labeled GE Prodigy and iDXA, n = 12,742), and the Canadian Longitudinal Study on Aging (CLSA, unlabeled Hologic Discovery A, n = 17,190). Unlabeled CLSA VFAs were split into five equal-sized partitions (n = 3438) and reviewed sequentially using active learning. Based on predicted fracture probability, 17.6% (n = 3032) of the unlabeled VFAs were selected for expert review using the modified algorithm-based qualitative (mABQ) method. CNNs were simultaneously trained on Hologic, GE dual-energy and GE single-energy VFAs. Two ensemble CNNs were constructed using the maximum and mean predicted probability from six separately trained CNNs that differed due to stochastic variation. CNNs were evaluated against the OsteoLaus validation set (n = 408) during the active learning process; ensemble performance was measured against the OsteoLaus test set (n = 819). RESULTS: The baseline CNN, prior to active learning, achieved 55.0% sensitivity, 97.9% specificity, 57.9% positive predictive value (PPV), F1-score 56.4%. Through active learning, 2942 CLSA Hologic VFAs (492 fractures) were added to the training data-increasing the proportion of Hologic VFAs with fractures from 4.2% to 12.5%. With active learning, CNN performance improved to 80.0% sensitivity, 99.7% specificity, 94.1% PPV, F1-score 86.5%. The CNN maximum ensemble achieved 91.9% sensitivity (100% for grade 3 and 95.5% for grade 2 fractures), 99.0% specificity, 81.0% PPV, F1-score 86.1%. CONCLUSION: Simultaneously training on a composite dataset consisting of both Hologic and GE VFAs allowed for the development of a single manufacturer-independent CNN that generalized to both scanner types with good classification performance. Active learning can reduce class imbalance and produce an effective medical image classifier while only labeling a subset of available unlabeled image data-thereby reducing the time and cost required to train a machine learning model.

A preliminary safety assessment of vertebral augmentation with32P brachytherapy bone cement.

Comprehensive treatment for vertebral metastatic lesions commonly involves vertebral augmentation (vertebroplasty or kyphoplasty) to relieve pain and stabilize the spine followed by multiple sessions of radiotherapy. We propose to combine vertebral augmentation and radiotherapy into a single treatment by adding32P, aß-emitting radionuclide, to bone cement, thereby enabling spinal brachytherapy to be performed without irradiating the spinal cord. The goal of this study was to address key dosimetry and safety questions prior to performing extensive animal studies. The32P was in the form of hydroxyapatite powder activated by neutron bombardment in a nuclear reactor. We performedex vivodosimetry experiments to establish criteria for safe placement of the cement within the sheep vertebral body. In anin vivostudy, we treated three control ewes and three experimental ewes with brachytherapy cement containing 2.23-3.03 mCi32P ml-1to identify the preferred surgical approach, to determine if32P leaches from the cement and into the blood, urine, or feces, and to identify unexpected adverse effects. Ourex vivoexperiments showed that cement with 4 mCi32P ml-1could be safely implanted in the vertebral body if the cement surface is at least 4 mm from the spinal cord in sheep and 5 mm from the spinal cord in humans.In vivo, a lateral retroperitoneal surgical approach, ventral to the transverse processes, was identified as easy to perform while allowing a safe distance to the spinal cord. The blood, urine, and feces of the sheep did not contain detectable levels of32P, and the sheep did not experience any neurologic or other adverse effects from the brachytherapy cement. These results demonstrate, on a preliminary level, the relative safety of this brachytherapy cement and support additional development and testing.

Assessment of clinical, imaging, surgical risk factors for subsequent fracture following vertebral augmentation in osteoporotic patients.

INTRODUCTION: Currently, the risk factors for subsequent fracture following vertebral augmentation remain incomplete and controversial. To provide clinicians with accurate information for developing a preventive strategy, we carried out a comprehensive evaluation of previously controversial and unexplored risk factors. METHODS: We retrospectively reviewed patients with osteoporotic vertebral compression fracture in lumbar spine who received vertebral augmentation between January 2019 and December 2020. Based on whether refracture occurred, patients were assigned to refracture and non-refracture group. The clinical characteristics, imaging parameters (severity of vertebral compression, spinal sagittal alignment, degeneration of paraspinal muscles), and surgical indicators (cement distribution and leakage, correction of spinal sagittal alignment) were collected and analyzed. RESULTS: There were 128 patients and 16 patients in non-refracture and refracture group. The incidence of previous fracture, multiple fractures, and cement leakage were notably higher, relative cross-sectional area of psoas (r-CSAPS) was significantly smaller, CSA ratio, fatty infiltration of erector spinae plus multifidus (FIES+MF), FIPS, postoperative lumbar lordosis (post-LL), correction of body angel (BA), and LL were significantly greater in refracture group. Binary logistic regression analysis revealed previous fracture, cement leakage, post-LL, and correction of BA were independent risk factors. According to the ROC curve, correction of BA showed the highest prediction accuracy, and the critical value was 3.45°. CONCLUSIONS: The occurrence of subsequent fracture might be the consequence of multiple factors. Previous fracture, cement leakage, post-LL, and correction of BA were identified as independent risk factors. Furthermore, the correction of BA should not exceed 3.45°, especially in patients with risk factors.

Development and Assessment of a Predictive Score for Vertebral Compression Fracture After Stereotactic Body Radiation Therapy for Spinal Metastases.

IMPORTANCE: Vertebral compression fracture (VCF) is a potential adverse effect following treatment with stereotactic body radiation therapy (SBRT) for spinal metastases. OBJECTIVE: To develop and assess a risk stratification model for VCF after SBRT. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study conducted at a high-volume referral center included 331 patients who had undergone 464 spine SBRT treatments from December 2007 through October 2019. Data analysis was conducted from November 1, 2020, to August 17, 2021. Exclusions included proton therapy, prior surgical intervention, vertebroplasty, or missing data. EXPOSURES: One and 3 fraction spine SBRT treatments were most commonly delivered. Single-fraction treatments generally involved prescribed doses of 16 to 24 Gy (median, 20 Gy; range, 16-30 Gy) to gross disease compared with multifraction treatment that delivered a median of 30 Gy (range, 21-50 Gy). MAIN OUTCOMES AND MEASURES: The VCF and radiography components of the spinal instability neoplastic score were determined by a radiologist. Recursive partitioning analysis was conducted using separate training (70%), internal validation (15%), and test (15%) sets. The log-rank test was the criterion for node splitting. RESULTS: Of the 331 participants, 88 were women (27%), and the mean (IQR) age was 63 (59-72) years. With a median follow-up of 21 months (IQR, 11-39 months), we identified 84 VCFs (18%), including 65 (77%) de novo and 19 (23%) progressive fractures. There was a median of 9 months (IQR, 3-21 months) to developing a VCF. From 15 candidate variables, 6 were identified using the backward selection method, feature importance testing, and a correlation heatmap. Four were selected via recursive partitioning analysis: epidural tumor extension, lumbar location, gross tumor volume of more than 10 cc, and a spinal instability neoplastic score of more than 6. One point was assigned to each variable, and the resulting multivariable Cox model had a concordance of 0.760. The hazard ratio per 1-point increase for VCF was 1.93 (95% CI, 1.62-2.30; P < .001). The cumulative incidence of VCF at 2 years (with death as a competing risk) was 6.7% (95% CI, 4.2%-10.7%) for low-risk (score, 0-1; 273 [58.3%]), 17.0% (95% CI, 10.8%-26.7%) for intermediate-risk (score, 2; 99 [21.3%]), and 35.4% (95% CI, 26.7%-46.9%) for high-risk cases (score, 3-4; 92 [19.8%]) (P < .001). Similar results were observed for freedom from VCF using stratification. CONCLUSIONS AND RELEVANCE: The results of this cohort study identify a subgroup of patients with high risk for VCF following treatment with SBRT who may potentially benefit from undergoing prophylactic spinal stabilization or vertebroplasty.

Utilization and Expenditures of Vertebral Augmentation Continue to Decline: An Analysis in Fee-For-Service (FFS) Recipients from 2009 to 2018.

BACKGROUND: Despite the high prevalence of vertebral compression fractures (VCFs) associated with refractory pain, deformity, or progressive neurological symptoms, minimally invasive vertebral augmentation procedures, including vertebroplasty and kyphoplasty, have been declining in their relative utilization, along with expenditures. OBJECTIVES: This investigation was undertaken to assess utilization and expenditures for vertebral augmentation procedures, including vertebroplasty and kyphoplasty, in the fee-for-service (FFS) Medicare population from 2009 to 2018. STUDY DESIGN: The present study was designed to assess utilization and expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. In this manuscript:• A patient was described as receiving vertebral augmentation over the course of the year.• An episode was considered as one treatment per region per day utilizing primary codes only. • Services or procedures were considered to be procedures including multiple levels.A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data for those enrolled in the FFS Medicare program from 2009 to 2018 was utilized. All the expenditures were presented with allowed costs and adjusted for inflation to 2018 US dollars. RESULTS: In 2009, there were 76,860 episodes of vertebral augmentation with a rate of 168 per 100,000 Medicare population, which declined to 58,760, or 99 per 100,000 population for a total decline of 41%, or an annual rate of decline of 5.7% per 100,000 Medicare population. Vertebroplasty interventions declined more dramatically than kyphoplasty from 2009. Total episodes of vertebroplasty were 27,380 with an annual rate of 60 per 100,000 Medicare population, decreasing to 9,240, or 16 per 100,000 Medicare population, a 66% decline in episodes and a 74% decline in overall rate with an annual decline of 11.4% and 13.9%. In contrast, kyphoplasty interventions were 49,480, for a rate per 100,000 population of 108 in 2009 compared to 49,520 in 2018 with a rate of 83, for a decrease of 23% and 2.9% annual decrease. Evaluation of expenditures showed a net decrease of $30,102,809, or 8%, from $378,758,311 in 2009 to $348,655,502 in 2018. However, inflation-adjusted expenditures decreased overall by 21% and 3% annually from $443,147,324 in 2009 to $345,655,502 in 2018. In addition, inflation-adjusted total expenditures per 100,000 Medicare population decreased from $967,549 to $584,992, for an overall decrease of 40%, or an annual decrease of 5%. Per patient expenditures decreased 2% overall with 0% decrease per year. LIMITATIONS: Vertebral augmentation procedures were assessed only in the FFS Medicare service population. This excluded over 30% of the Medicare population, which is enrolled in Medicare Advantage plans. CONCLUSIONS: This study shows a significant decline in relative utilization patterns of vertebroplasty and kyphoplasty procedures, along with reductions in overall expenditures. The inflation-adjusted total expenditures of kyphoplasty and vertebroplasty decreased 21% with an annual decline of 3%. The inflation-adjusted expenditures per 100,000 of Medicare population decreased 40% overall and 5% per year. In addition, vertebroplasty has seen substantial declines in utilization and expenditure patterns compared to kyphoplasty procedures, which showed trends of decline.

Beijing Friendship Hospital Osteoporosis Self-Assessment Tool for Elderly Male (BFH-OSTM) vs Fracture Risk Assessment Tool (FRAX) for identifying painful new osteoporotic vertebral fractures in older Chinese men: a cross-sectional study.

BACKGROUND: To compare the validation of four tools for identifying painful new osteoporotic vertebral compression fractures (PNOVCFs) in older Chinese men: bone mineral density (BMD), Asian osteoporosis self-assessment tool (OSTA), World Health Organization fracture risk assessment tool (FRAX) (without BMD) and Beijing Friendship Hospital Osteoporosis Self-Assessment Tool (BFH-OSTM). METHODS: A cross sectional study was conducted from 2013 to 2019. A total of 846 men aged ≥50 were included and were divided into two groups: Fracture Group (patients with PNOVCFs underwent percutaneous vertebroplasty surgery) and Non-Fracture Group (community dwelled subjects for healthy examination). All subjects accepted a dual-energy X-ray BMD test and a structured questionnaire. The results of BMD, OSTA, FRAX and BFH-OSTM scores were assessed and receiver-operating characteristic (ROC) curves were generated to compare the validity of four tools for identifying PNOVCFs. Optimal cutoff points, sensitivity, specificity, and areas under the ROC curves (AUCs) were determined. RESULTS: There were significant differences including BMD T score (femoral neck, total hip and L1-L4), OSTA, FRAX and BFH-OSTM scores between Fracture group and Non-fracture group. Compared to BMD and OSTA, BFH-OSTM and FRAX had better predictive value, the sensitivity, specificity and AUC value are 0.841, 81.29%, 70.67% and 0.796, 74.85%, 78.52%, respectively. Compared with FRAX, the BFH-OSTM has a better AUC value. CONCLUSIONS: Both BFH-OSTM and FRAX can be used to identify POVCFs, However, BFH-OSTM model may be a more simple and effective tool to identify the risk of POVCFs in Chinese elderly men.