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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 . . .

Background The aging of China's population has led to an increase in the incidence rate of osteoporosis, which indirectly increases the risk of OVCF in osteoporosis patients. Low back pain is the main symptom of OVCF, and severe patients can further develop kyphosis. Although the conservative treatment of OVCF can effectively control the patient's condition, long-term bed rest will increase the risk of OVCF complications. Minimally invasive surgery is a common solution for OVCF. Methods 100 OVCF patients admitted to our hospital from January 2021 to January 2022 are selected for analysis and randomly divided into PVP group and PKP group, 50 cases in each group. The PVP group and the PKP group undergo PVP and PKP operations respectively. The differences in efficacy indicators and adverse reactions are compared, and the multivariate Logistic regression method is used to analyze the influencing factors of postoperative secondary fractures in patients with vertebral compression fractures. Results Compared with the PVP group, the total effective rate of PKP group is significantly increased, and the VAS, ODI score, kyphotic Cobb Angle, lateral distribution rate of bone cement and bone cement leakage rate are significantly decreased ( P  < 0.05). Age ≥ 80 years old, female, glucocorticoid use, lateral distribution of bone cement and bone cement leakage are significantly higher in the proportion of secondary fractures and are independent risk factors for postoperative secondary fractures in patients with OVCF. Conclusion PKP surgery has a higher efficacy in the treatment of OVCF patients, which can reduce the incidence of pain, adverse reactions and promote the recovery of kyphotic Cobb Angle. PKP surgery has a higher value in the treatment of OVCF. In addition, the influencing factors of secondary fracture after minimally invasive surgery in OVCF patients include age, gender, glucocorticoid use, bone cement distribution pattern, bone cement leakage, etc.

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.

Background Percutaneous kyphoplasty (PKP) is an effective treatment for osteoporotic vertebral compression fractures (OVCFs) and provides effective pain relief; however, its efficacy is questionable in patients with thoracic OVCFs combined with intercostal neuralgia (IN). This study aims to compare the efficacy and safety of thoracic paravertebral nerve block (TPVB) and local infiltration (LI) anesthesia for PKP to treat thoracic OVCFs combined with IN. Methods Patients with OVCFs combined with IN scheduled to undergo PKP between January 2021 and June 2022 were randomized into the following groups: TPVB and LI. Intraoperative visual analog scale (VAS) score, patients’ anesthesia satisfaction (PAS) score, mean arterial pressure (MAP), and heart rate (HR) were recorded. Follow-up consultations were scheduled at 1 day, 1 month, 3 months, and 6 months postoperatively, recording the demographic characteristics, including surgical information, and complications observed in both groups. The clinical evaluation parameters included the VAS score, Oswestry Disability Index (ODI), and Short Form (SF)-36 score. Radiological evaluation parameters included the anterior vertebral body height ratio (AVBHR) and Cobb’s angle of the injured vertebra. Results Sixty patients were enrolled (30 in each group), with similar clinical and demographic characteristics. The mean intraoperative VAS scores from time points T1 to T5 were significantly lower in the TPVB group [2 (1–2), 3 (2–3), 3 (3–4), 3 (2–3), and 2 (2–2)] than in the LI group [2 (2–3), 4 (3–4), 4 (3–5), 3.5 (3–4), and 3 (3–3)]. The PAS scores were significantly higher in the TPVB group [3(3–3)] than in the LI group [2(2–3)]. The TPVB group demonstrated significantly better clinical outcomes than that of the LI group at 1 day postoperatively, as evidenced by higher VAS, ODI, and SF-36 bp scores. The corresponding scores in the TPVB group were 2 (2–2), 20.47 ± 3.14, and 84 (84–84), respectively, and in the LI group were 3 (3–3), 22.53 ± 4.20, and 84 (74–84), respectively ( p  < 0.05). No statistically significant differences in radiological terms were observed between the two groups. No postoperative complications were observed in either group. Conclusions Compared to LI, TPVB provided better intraoperative and postoperative short-term analgesia with an equivalent safety profile when administered to patients with OVCFs combined with IN. Trial registration ChiCTR2000035034, 28/07/2020, https//www.chictr.org.cn.

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

Purpose To compare the clinical and radiological outcomes of patients undergoing percutaneous vertebroplasty (PVP) versus those undergoing facet blocking (FB) for severe pain due to osteoporotic vertebral compression fractures (OVCFs). Methods Two hundred and six patients who had OVCFs on spine radiography and intractable back pain for ≤8 weeks were recruited between January 2009 and January 2013 (165 females and 41 males, age ≥55 years). Patients were randomly assigned to the PVP group (100 patients) or the FB group (106 patients). VAS, ODI, Roland Morris disability (RMD) scores, scores on the Standardized Physical Component of the SF-36 form (SPC) and scores on the Standardized Mental Component of the SF-36 form (SMC) were determined preoperatively and at each follow-up time (1 day, 1 week, 1, 3, 6, and 12 months). In addition, plain radiographs were obtained at 3, 6, and 12 months postoperatively to detect new fractures. Results Significantly lower VAS, ODI, and RMD scores for patients in the PVP group compared to those in the FB group were observed at follow-up of 1 day and 1 week ( p  < 0.05). However, differences in the VAS, ODI, RMD and SPC/MCS (SF-36) scores between the two groups at follow-ups of more than 1 month were statistically insignificant ( p  > 0.05). Difference in numbers of new fractures in the two groups at the follow-up of 12 months was also statistically insignificant. Conclusions PVP produced better pain relief than FB in the short term (≤1 week). However, the difference in pain-relief between these two techniques was insignificant in the long term (follow-up between 1 month and 12 months).

The Cochrane vertebroplasty review of April 2018 was replaced with an updated version in November 2018 to address complaints of errors in analysis. The updated version continues to misrepresent the evidence supporting early intervention with vertebroplasty for patients with uncontrolled, severe pain and fracture duration <6 weeks. The VAPOUR trial is the only blinded trial of vertebroplasty restricted to this patient group. It showed the benefit of vertebroplasty over placebo, particularly when the intervention occurred within 3 weeks of fracture. The Cochrane vertebroplasty review has ignored the positive outcomes in the VAPOUR trial. Open randomised trials of fractures <6-week duration support the positive findings of the VAPOUR trial. This is not described in the Cochrane review. The VAPOUR trial is clinically heterogeneous from other blinded trials. Cochrane protocol stipulates that clinically heterogeneous trials be described separately, as independent evidence, and not combined in analysis with dissimilar trials. Failure to observe this represents a serious protocol breach in the Cochrane review.

PurposeOsteoporotic vertebral compression fractures (OVCFs) are common in the elderly population and are often treated using percutaneous vertebroplasty (PVP). However, the effectiveness of PVP reported by various randomized controlled trials (RCTs) is inconclusive. This study aimed to analyze, from published literature, the efficacy and safety of PVP for OVCFs.MethodsA search was conducted in Medline, EMBASE, and Cochrane Libraries since their respective inception on January 1, 2019, for RCTs of OVCFs treated with PVP compared with non-operative treatment. The primary outcomes were pain relief at 1 to 2 weeks, 1 to 3 months, and 6 to 12 months. The secondary outcome was the rate of occurrence of new vertebral fractures. Meta-analysis was performed using a random effect model.ResultsA total of 13 RCTs comprising 1624 patients were included. For the blinded studies, statistical differences were found between PVP and the sham injection group for the 3 primary outcomes in the subgroup of the Vertebroplasty for Acute Painful Osteoporotic fractURes (VAPOUR) trial. Although pain scores were similar between the PVP group and the sham injection group for the VAPOUR trial at each period, the effect size of PVP increased over time. For the open-label studies, PVP significantly reduced pain at all time points. The risk of new vertebral fractures was similar between the PVP groups and control groups.ConclusionsApplication of PVP was effective and safe only in patients with acute OVCFs having persistent and severe pain. No benefits were recorded, among patients with older fractures or those bearing non-severe symptoms.

We performed a randomized, double-blind, controlled clinical trial comparing intravenous pamidronate and placebo for pain relief in recent osteoporotic vertebral compression fractures (VCF). Patients suffered from recent (<21 days), painful, osteoporosis-related VCF. They were randomized to receive daily intravenous infusions of either placebo or 30 mg pamidronate for three consecutive days (total pamidronate: 90 mg). The main criterion for efficacy was improvement in standing pain on a 100-mm visual analogical scale (VAS) at day 7. Secondary criteria were standing pain at days 3 and 30; supine pain at days 3, 7, and 30; patients' overall assessment of improvement; mobility index; and number of \"20% responders\" and \"50% responders\" (respectively, 20% and 50% improvement in standing pain at days 7 and 30). Statistical analysis with non-parametric tests was carried out on an intention to treat basis. Thirty-two patients were enrolled in the study; 16 were given placebo and 16 pamidronate. Thirty-one patients were evaluated at day 7 and 26 patients at day 30. VAS pain decreased significantly in both groups at day 7 (placebo -23 mm, pamidronate -42 mm, p<0.01). The difference in pain scores between groups was -23.25 mm (confidence interval (CI) [-42.3; -4.2], p=0.018) at day 7 and -26 mm at day 30 (p=0.03), in favor of pamidronate. At day 7, there were 4 versus 12 \"50% responders,\" respectively, in the placebo and in the pamidronate groups (likelihood ratio: 8.372; p=0.004) and 9 versus 14 \"20% responders\" (likelihood ratio: 4.038; p=0.044). At day 30, there were 5 versus 10 \"50% responders,\" respectively, in the placebo and in the pamidronate groups, and 7 versus 11 \"20% responders.\" Patients' overall assessment of improvement at day 7 was 37+/-26 mm in the placebo group and 59+/-30 mm in the pamidronate group (p=0.019), and 42+/-26 mm and 72+/-21 mm at day 30 (p=0.07). The two groups did not differ significantly at days 7 and 30 for supine pain, Schober index, or finger-ground distance. No significant adverse reaction related to treatment occurred. Pamidronate provides rapid and sustained pain relief in patients with acute painful osteoporotic VCF and is well tolerated. Further investigations are needed to better define the place of pamidronate in the management of painful recent osteoporotic collapse.

Background Vertebral compression fractures decrease daily life activities and increase economic and social burdens. Aging decreases bone mineral density (BMD), which increases the incidence of osteoporotic vertebral compression fractures (OVCFs). However, factors other than BMD can affect OVCFs. Sarcopenia has been a noticeable factor in the aging health problem. Sarcopenia, which involves a decrease in the quality of the back muscles, influences OVCFs. Therefore, this study aimed to evaluate the influence of the quality of the multifidus muscle on OVCFs. Methods We retrospectively studied patients aged 60 years and older who underwent concomitant lumbar MRI and BMD in the university hospital database, with no history of structurally affecting the lumbar spine. We first divided the recruited people into a control group and a fracture group according to the presence or absence of OVCFs, and further divided the fracture group into an osteoporosis BMD group and an osteopenia BMD group based on the BMD T-score of -2.5. Using images of lumbar spine MRI, the cross-sectional area and percentage of muscle fiber (PMF) of the multifidus muscle were obtained. Results We included 120 patients who had visited the university hospital, with 45 participants in the control group and 75 in the fracture group (osteopenia BMD: 41, osteoporosis BMD: 34). Age, BMD, and the psoas index significantly differed between the control and fracture groups. The mean cross-sectional area (CSA) of multifidus muscles measured at L4-5 and L5-S1, respectively, did not differ among the control, P-BMD, and O-BMD groups. On the other hand, the PMF measured at L4-5 and L5-S1 showed a significant difference among the three groups, and the value of the fracture group was lower than that of the control group. Logistic regression analysis showed that the PMF value, not the CSA, of the multifidus muscle at L4-5 and L5-S1 affected the risk of OVCFs, with and without adjusting for other significant factors. Conclusions High percentage of fatty infiltration of the multifidus muscle increases the spinal fracture risk. Therefore, preserving the quality of the spinal muscle and bone density is essential for preventing OVCFs.