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In this randomized trial involving patients with osteoporotic vertebral compression fractures, patients who underwent vertebroplasty had improvements in pain and disability measures that were similar to those in patients who underwent a sham procedure. Patients who underwent vertebroplasty had improvements in pain and disability measures that were similar to those in patients who underwent a sham procedure. Spontaneous vertebral fractures are associated with pain, disability, and death in patients with osteoporosis. Percutaneous vertebroplasty, the injection of medical cement, or polymethylmethacrylate (PMMA), into the fractured vertebral body has gained widespread acceptance as an effective method of pain relief and has become routine therapy for osteoporotic vertebral fractures. Guidelines recommend vertebroplasty for fractures that have not responded to medical treatment. 1 Typically, the duration of such fractures ranges from several weeks to several months or longer for fractures that have not healed. Numerous case series and several small, unblinded, nonrandomized, controlled studies have suggested the effectiveness of vertebroplasty in relieving . . .

The aim of this research was to conduct randomized trials assessing the extent of cement diffusion following robot-assisted percutaneous vertebroplasty (R-PVP) for osteoporotic vertebral compression fractures (OVCF). A total of 96 OVCF patients meeting the inclusion criteria and admitted between January 2023 and November 2023 were included in the study. Among them, 48 patients were assigned to the robotic-assisted PVP group (R-PVP group) and 48 patients were assigned to the traditional PVP group (PVP group). The study examined the differences in age, sex, BMD T-value, fracture segment, preoperative, postoperative, and 3-month postoperative visual analogue scale (VAS) and Oswestry disability index (ODI) pain scores, fluoroscopic dose, frequency of fluoroscopy, volume of bone cement injected, angle of puncture abduction, degree of cement diffusion, and bone cement spillage among the two patient groups. A logistic regression model was employed to analyze the factors influencing the extent of postoperative bone cement diffusion. The findings indicated that the R-PVP group exhibited a significantly larger puncture abduction angle, improved postoperative cement dispersion, increased cement injection volume, and decreased incidence of cement spillage compared to the PVP group. Furthermore, the R-PVP group demonstrated superior outcomes in these aspects, as well as lower intraoperative fluoroscopic frequency and radiation exposure. Additionally, bone density, puncture abduction angle, cement injection volume, and surgical approach were identified as independent factors associated with the extent of postoperative cement dispersion.

Balloon kyphoplasty is a minimally invasive procedure for the treatment of painful vertebral fractures, which is intended to reduce pain and improve quality of life. We assessed the efficacy and safety of the procedure. Adults with one to three acute vertebral fractures were eligible for enrolment in this randomised controlled trial at 21 sites in eight countries. We randomly assigned 300 patients by a computer-generated sequence to receive kyphoplasty treatment (n=149) or non-surgical care (n=151). The primary outcome was the difference in change from baseline to 1 month in the short-form (SF)-36 physical component summary (PCS) score (scale 0–100) between the kyphoplasty and control groups. Quality of life and other efficacy measurements and safety were assessed up to 12 months. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00211211. 138 participants in the kyphoplasty group and 128 controls completed follow-up at 1 month. By use of repeated measures mixed effects modelling, all 300 randomised participants were included in the analysis. Mean SF-36 PCS score improved by 7·2 points (95% CI 5·7–8·8), from 26·0 at baseline to 33·4 at 1 month, in the kyphoplasty group, and by 2·0 points (0·4–3·6), from 25·5 to 27·4, in the non-surgical group (difference between groups 5·2 points, 2·9–7·4; p<0·0001). The frequency of adverse events did not differ between groups. There were two serious adverse events related to kyphoplasty (haematoma and urinary tract infection); other serious adverse events (such as myocardial infarction and pulmonary embolism) did not occur perioperatively and were not related to procedure. Our findings suggest that balloon kyphoplasty is an effective and safe procedure for patients with acute vertebral fractures and will help to inform decisions regarding its use as an early treatment option. Medtronic Spine LLC.

BackgroundPercutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure.MethodsVERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. New OVCFs and further vertebral height loss were assessed at 3, 6, and 12 months.ResultsAfter a median follow-up of 12 months (interquartile range (IQR) = 12–12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (χ2(1) = 0.83, p = 0.36, OR = .71, 95%CI = 0.33–1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (χ2(1) = 28.85, p < 0.001, OR = 9.84, 95%CI = 4.08–23.73)) and was more severe (p < .001) than after PV.ConclusionsThe risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protects against progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs.Level of EvidenceLevel 1a, therapeutic study.ClinicalTrials.gov number, NCT01200277

Objective To compare the efficacy and safety of vertebroplasty through different pedicle approaches in the treatment of osteoporotic vertebral compression fracture osteoporotic vertebral compression fractures (OVCF) by network meta-analysis. Methods Pubmed, Embase, Cochrane Library, Web of Science. Database for literature retrieval, retrieval time from the establishment of the database to April 2023, the randomized controlled trials of unilateral vertebroplasty (UVP), bilateral vertebroplasty (BVP), unilateral kyphoplasty (UKP), bilateral kyphoplasty (BKP), curved vertebroplasty (CVP) and curved kyphoplasty (CKP) were screened, evaluated and the data were extracted and included in the analysis. STATA 15.0 and ReMan 5.3 were used for data analysis. This study was registered in the National Institute for Health Research (NIHR) with the registration number CRD42023405181. Results This study included 16 articles with a total of 1712 patients. The order of visual analogue scale (VAS) improvement from good to bad is CVP > BVP > UVP > CKP > BKP > UKP. The order of kyphotic angles improvement from good to bad is CKP > UKP > UKP > UVP > BVP > CVP. The order of bone cement injection from less to more is UVP > CVP > UKP > CKP > BVP > BKP. The order of bone cement leakage rate from less to more is CKP > CVP > UKP > BKP > UVP > BVP. The order of X-ray exposure time from less to more is CKP > CVP > UVP > BVP > UKP > BKP. The order of operation time from less to more is CVP > UVP > UKP > CKP > BVP > BKP. Conclusion For patients with kyphotic angles, kyphoplasty has unique advantages in improving kyphotic angles. But generally speaking, curved approach can optimize the distribution of bone cement through unilateral approach to achieve the orthopedic effect of bilateral approach, which is a minimally invasive technique with better curative effect and higher safety in the treatment of OVCF.

Objective To investigate the clinical effect of vertebroplasty through unilateral upper edge of transverse process in the treatment of lumbar osteoporotic vertebral compression fracture (OVCF), and to explore the surgical indications and operation points of this technique. Methods Ninety patients with osteoporotic vertebral compression fractures of the lumbar spine treated in our hospital from June 2020 to June 2021 were retrospectively analyzed and divided into the experimental group and the control group for vertebroplasty according to the principle of randomization; the experimental group was treated with a lateral pedicle approach through the upper edge of the unilateral transverse process, and the control group was treated with a unilateral pedicle approach. After more than 1 year of follow-up, the operation time, intraoperative fluoroscopy times, bone cement injection volume, Oswestry disability index (ODI), Visual analogue scale (VAS) were compared between the two groups to assess the functional recovery of the patients. Results There was no significant difference in the general data (age, gender, location and number of fractured vertebral bodies, and follow-up time) between the two groups before surgery. In the experimental group, there were 42 OVCF patients (15 males and 27 females), and the operated segments were L1 vertebral body in 17 cases, L2 vertebral body in 13 cases, L3 vertebral body in 8 cases, L4 vertebral body in 3 cases, and L5 vertebral body in 1 case. The control group consisted of 48 OVCF patients (16 males and 32 females), and the operated segments were L1 vertebral body in 21 cases, L2 vertebral body in 15 cases, L3 vertebral body in 8 cases, L4 vertebral body in 2 cases, and L5 vertebral body in 2 cases. In terms of operation time and intraoperative fluoroscopy times, the experimental group was less than the control group, and the difference had statistical significance ( P  < 0.05); in terms of bone cement injection volume, the difference between the two groups had no statistical significance ( P  > 0.05); in terms of pain VAS score and dysfunction index ODI score, the scores of the two groups were improved with the extension of follow-up time compared with those before surgery, but the difference between the two groups had no statistical significance ( P  > 0.05). Conclusion Compared with the traditional approach, PVP via the unilateral extrapedicular approach at the upper edge of the transverse process has the advantages of less operation time and fluoroscopy times, uniform diffusion of bone cement, and is comparable to the traditional surgical approach in relieving pain and improving patient function, but due to the limitation of the length of the puncture needle, careful operation is required during the operation.

Background Percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP) are widely used in the treatment of Kümmell’s disease. The purpose of this article is to investigate the clinical efficacy of PVP and PKP for Kümmell’s disease. Methods The clinical data that 56 cases of Kümmell’s disease treated with either PVP (28 cases) or PKP (28 cases) from December 2015 to December 2017 were prospectively analyzed. Gender, age, course of disease, injury segment, bone mineral density (BMD), visual analogue scale (VAS), Oswestry disability index (ODI), imaging measurement indexes before surgery between the two groups showed no significant difference (all P  > 0.05). The bone cement leakage rate, bone cement injection amount, operation time, VAS, ODI, the rate of vertebral compression, correction rate of kyphosis and refracture rate of adjacent vertebra in 2 years were compared between the two groups to calculate clinical efficacy. Results The two groups were followed up for 24–48 months. There was no significant difference in the follow-up time, amount of bone cement injected, incidence of bone cement leakage and refracture rate of adjacent vertebrae between the two groups (all P  > 0.05). The operation time, intraoperative blood loss and fluoroscopy times of the PVP group were significantly lower than those of the PKP group (all P  = 0.000). VAS score and ODI of the two groups were significantly lower at 1 day, 1 year and 2 years after surgery than before surgery (all P  < 0.05), but there was not statistically significant difference between the two groups at each time point after surgery (all P  > 0.05). The rate of vertebral compression and kyphosis correction in the two groups were significantly corrected ( P  < 0.05, respectively) and decreased significantly with time (all P  < 0.05), But there was not significant difference between the two groups at any time point (all P  > 0.05). Conclusion Both PVP and PKP can achieve similar effects in the treatment of Kümmell’s disease. Because the cost, operation time, blood loss, radiation exposure and surgical procedure of PVP are less than those of PKP, PVP has more clinical priority value.

Summary The purpose of this study was to determine the real-world incidence and predictors of additional vertebroplasty or balloon kyphoplasty after initial vertebral augmentation, as a proxy for subsequent symptomatic vertebral fracture. Of patients, 15.5% underwent subsequent vertebral augmentation. The patient’s comorbidities are strongly associated with risk of subsequent treatment. Purpose To determine the real-world incidence and predictors of additional vertebroplasty or balloon kyphoplasty after initial vertebral augmentation, as a proxy for subsequent symptomatic and disabling vertebral fracture. Methods We conducted a retrospective cohort study using commercial insurance claims data (Optum’s de-identified Clinformatics® Data Mart Database). Adult patients who underwent subsequent treatment for vertebral fracture within 24 months of initial balloon kyphoplasty (BKP) or vertebroplasty (VP) were classified into “subsequent treatment” or “no subsequent treatment” cohorts. Survival analysis was applied to investigate the effect of risk factors on subsequent treatment. Results Between 1 January 2008 and 30 June 2020, a total of 32,513 adult patients underwent a BKP/VP procedure following a diagnosis of vertebral compression fracture in the preceding 12 months. Five thousand thirty-five patients (15.5%) underwent a subsequent BKP/VP treatment within 2 years; 90% had a single fracture level treated. An increased hazard of subsequent treatment was associated with a number of fractures treated at initial BKP/VP (≥ 4 levels, adjusted hazard ratio (AHR) 1.68 (95% CI 1.24–2.26); steroid use, AHR 1.9 (95% CI 1.31–1.48); Elixhauser Comorbidity Index ≥ 4, AHR 1.44 (95% CI 1.17–1.77); and multiple myeloma, AHR 1.31 (95% CI 1.13–1.53)). Age < 70 years was associated with reduced hazard of subsequent treatment (AHR 0.81, 95% CI 0.74–0.89). Conclusions One in seven patients underwent subsequent treatment for vertebral fracture after initial vertebral augmentation. Baseline patient characteristics were associated with increased risk of subsequent fracture within 2 years, suggesting that a patient’s natural history is strongly associated with risk of subsequent treatment rather than the initial surgical procedure itself.

Purpose The purpose of the present study is to identify independent risk factors for the occurrence of cement leakage (CL) during percutaneous vertebroplasty (PVP) for four different leakage types in treating osteoporotic vertebral compression fractures (OVCFs). Methods We retrospectively reviewed 292 patients who underwent PVP for single-level OVCF from January 2009 to March 2011. The influences of several potential risk factors that might affect the occurrence of CL were assessed using univariate and multivariate analyses. Cement leakage was evaluated by computed tomography and classified into four different types: through the basivertebral vein (B-type), the segmental vein (S-type), a cortical defect (C-type), and intradiscal leakage (D-type). Results Cement leakage was found in 227 of the 292 treated vertebrae. None of the parameters showed a statistically significant effect by univariate analysis. However, multivariate analysis showed that cement viscosity was an independent risk factor in B-type CL, fracture severity and fracture type were in S-type CL, fracture severity and presence of cleft on MRI were in C-type CL, and fracture severity, cortical disruption on MRI, presence of cleft on MRI and cement viscosity were in D-type CL. Conclusion Each different vertebral fracture pattern has its own risk factors for CL. Identification of the above predicting factors for CL preoperatively might be helpful for more rigorous and strict patient selection criteria for the appropriate candidates for PVP.

In this multicenter, randomized, double-blind, placebo-controlled trial involving patients with one or two painful osteoporotic vertebral fractures, vertebroplasty did not result in greater improvement than a sham procedure in overall pain, physical functioning, or quality of life at 3 or 6 months after treatment. In patients with one or two painful osteoporotic vertebral fractures, vertebroplasty did not result in greater improvement than a sham procedure in overall pain, physical functioning, or quality of life at 3 or 6 months after treatment. Osteoporotic vertebral fractures are a common cause of pain and disability and are associated with increased mortality. 1 Approximately 750,000 new vertebral fractures occur in the United States each year, 2 and among people who are older than 50 years of age, up to a quarter of them will have at least one vertebral fracture in their lifetime 3 Although most fractures heal within a few months, some people have pain and disability that fail to respond to conservative therapy, and some require hospitalization, long-term care, or both. 4 Therefore, interventions that effectively manage pain and shorten recovery time would be of great benefit. . . .