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AbstractObjectiveTo assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body.DesignRandomised, double blind, sham controlled clinical trial.SettingFour community hospitals in the Netherlands, 2011-15.Participants180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89).InterventionsParticipants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group.Main outcome measuresMain outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months’ follow-up.ResultsThe mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval −0.53 to 0.94) at baseline, −0.43 (−1.17 to 0.31) at one day, −0.11 (−0.85 to 0.63) at one week, 0.41 (−0.33 to 1.15) at one month, 0.21 (−0.54 to 0.96) at three months, 0.39 (−0.37 to 1.15) at six months, and 0.45 (−0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months’ follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction.ConclusionsPercutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months’ follow-up among patients with acute osteoporotic vertebral compression fractures.Trial registrationClinicalTrials.gov NCT01200277.

SummaryPatients with Parkinson’s disease (PD) were at higher risk of osteoporotic vertebral compression fractures (OVCF) compared to controls and had elevated mortality rates. Compared to conservative treatment, surgical treatment for OVCF in PD patients seemed to be associated with better outcomes.IntroductionThe purpose of this study was to evaluate the risk of OVCF in patients with PD.MethodsData from patients over the age of 60 years who were diagnosed with PD were collected between 2004 and 2013 from the Korean National Health Insurance Database (n = 3370). The comparison group (non-PD) consisted of randomly selected patients (five per patient with PD; n = 16,850) matched to the PD group, who were newly diagnosed annually according to age and sex. Cox proportional hazard regressions were used to examine the relationships between osteoporosis, OVCF, surgery for OVCF, and PD. Household income and residential area of patients were also assessed. Overall survival rates were calculated after adjusting for confounding factors, such as hypertension, diabetes mellitus, and chronic kidney disease.ResultsOVCF was developed in 12.5% of patients in the PD group and in 7.4% of patients in the control group. PD was associated with increased risk of osteoporosis (hazard ratio [HR], 1.32; 95% confidence interval [CI], 1.21–1.43; p < 0.001), OVCF (HR 1.66; 95% CI, 1.47–1.87; p < 0.001), and surgery for OVCF (HR 2.69; 95% CI, 1.78–4.08; p < 0.001). Household income was not significantly related with development of osteoporosis, incidence of OVCF, or surgery for OVCF. Residential area was statistically associated with osteoporosis, OVCF, and surgery for OVCF. The mortality rate of the PD group was about 1.7 times higher than that of the non-PD group after adjusting for potential confounders, and the mortality rate of the PD with OVCF group was higher than that of the non-PD group, but not significantly (p = 0.09). The survival rate of the PD group with surgery for OVCF showed a trend toward a more positive prognosis compared with that of the PD group with conservative treatment.ConclusionsPatients with PD had significantly increased risk of osteoporosis and OVCF. Surgical treatment for OVCF in PD patients was associated with a better prognosis than conservative treatment.

Non-randomised trials have reported benefits of kyphoplasty in patients with cancer and vertebral compression fractures (VCFs). We aimed to assess the efficacy and safety of balloon kyphoplasty compared with non-surgical management for patients with cancer who have painful VCFs. The Cancer Patient Fracture Evaluation (CAFE) study was a randomised controlled trial at 22 sites in Europe, the USA, Canada, and Australia. We enrolled patients aged at least 21 years who had cancer and one to three painful VCFs. Patients were randomly assigned by a computer-generated minimisation randomisation algorithm to kyphoplasty or non-surgical management (control group). Investigators and patients were not masked to treatment allocation. The primary endpoint was back-specific functional status measured by the Roland-Morris disability questionnaire (RDQ) score at 1 month. Outcomes at 1 month were analysed by modified intention to treat, including all patients with data available at baseline and at 1 month follow-up. Patients in the control group were allowed to crossover to receive kyphoplasty after 1 month. This study is registered with ClinicalTrials.gov, NCT00211237. Between May 16, 2005, and March 11, 2008, 134 patients were enrolled and randomly assigned to kyphoplasty (n=70) or non-surgical management (n=64). 65 patients in the kyphoplasty group and 52 in the control group had data available at 1 month. The mean RDQ score in the kyphoplasty group changed from 17·6 at baseline to 9·1 at 1 month (mean change −8·3 points, 95% CI −6·4 to −10·2; p<0·0001). The mean score in the control group changed from 18·2 to 18·0 (mean change 0·1 points; 95% CI −0·8 to 1·0; p=0·83). At 1 month, the kyphoplasty treatment effect for RDQ was −8·4 points (95% CI −7·6 to −9·2; p<0·0001). The most common adverse events within the first month were back pain (four of 70 in the kyphoplasty group and five of 64 in the control group) and symptomatic vertebral fracture (two and three, respectively). One patient in the kyphoplasty group had an intraoperative non-Q-wave myocardial infarction, which resolved and was attributed to anaesthesia. Another patient in this group had a new VCF, which was thought to be device related. For painful VCFs in patients with cancer, kyphoplasty is an effective and safe treatment that rapidly reduces pain and improves function. Medtronic Spine LLC.

Percutaneous vertebroplasty is increasingly used for treatment of pain in patients with osteoporotic vertebral compression fractures, but the efficacy, cost-effectiveness, and safety of the procedure remain uncertain. We aimed to clarify whether vertebroplasty has additional value compared with optimum pain treatment in patients with acute vertebral fractures. Patients were recruited to this open-label prospective randomised trial from the radiology departments of six hospitals in the Netherlands and Belgium. Patients were aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss; level of fracture at Th5 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 5 or more. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment by computer-generated randomisation codes with a block size of six. Masking was not possible for participants, physicians, and outcome assessors. The primary outcome was pain relief at 1 month and 1 year as measured by VAS score. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT00232466. Between Oct 1, 2005, and June 30, 2008, we identified 431 patients who were eligible for randomisation. 229 (53%) patients had spontaneous pain relief during assessment, and 202 patients with persistent pain were randomly allocated to treatment (101 vertebroplasty, 101 conservative treatment). Vertebroplasty resulted in greater pain relief than did conservative treatment; difference in mean VAS score between baseline and 1 month was −5·2 (95% CI −5·88 to −4·72) after vertebroplasty and −2·7 (−3·22 to −1·98) after conservative treatment, and between baseline and 1 year was −5·7 (−6·22 to −4·98) after vertebroplasty and −3·7 (−4·35 to −3·05) after conservative treatment. The difference between groups in reduction of mean VAS score from baseline was 2·6 (95% CI 1·74–3·37, p<0·0001) at 1 month and 2·0 (1·13–2·80, p<0·0001) at 1 year. No serious complications or adverse events were reported. In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost. ZonMw; COOK Medical.

Abstract BACKGROUND Osteoporotic and neoplastic vertebral compression fractures (VCF) are common and painful, threatening quality of life and increasing risk of morbidity and mortality. Balloon kyphoplasty is a percutaneous option for treating painful cancer- and osteoporosis-related VCFs, supported by 2 randomized trials demonstrating efficacy benefits of BKP over nonsurgical care. OBJECTIVE To investigate 12-mo disability, quality of life, and safety outcomes specifically in a Medicare-eligible population, representing characteristic patients seen in routine clinical practice. METHODS A total of 354 patients with painful VCFs were enrolled at 24 US sites with 350 undergoing kyphoplasty. Four coprimary endpoints—Numerical Rating Scale (NRS) back pain, Oswestry Disability Index (ODI), Short Form-36 Questionnaire Physical Component Summary (SF-36v2 PCS), EuroQol-5-Domain (EQ-5D)—were evaluated for statistically significant improvement 3 mo after kyphoplasty. Data were collected at baseline, 7 d, and 1, 3, 6, and 12 mo (www.clinicaltrials.gov registration NCT01871519). RESULTS At the 3-mo primary endpoint, NRS improved from 8.7 to 2.7 and ODI improved from 63.4 to 27.1; SF-36 PCS was 24.2 at baseline improving to 36.6, and EQ-5D improved from 0.383 to 0.746 (P < .001 for each). These outcomes were statistically significant at every follow-up time point. Five device-/procedure-related adverse events, intraoperative asymptomatic balloon rupture, rib pain, and aspiration pneumonia, and a new VCF 25 d postprocedure, and myocardial infarction 105 d postprocedure were reported and each resolved with proper treatment. CONCLUSION This large, prospective, clinical study demonstrates that kyphoplasty is a safe, effective, and durable procedure for treating patients with painful VCF due to osteoporosis or cancer.

Background One in three women and one in five men over the age of 50 will experience an osteoporotic fracture. Vertebral fractures can be very painful, affect patients’ daily function, and in severe cases require hospitalization. Traditionally, fracture pain is treated conservatively with analgesics, and bracing. Vertebral augmentation, also known as vertebroplasty, has been used during the last three decades as a minimally invasive treatment option for vertebral compression fractures, but the evidence base for its efficacy is weak. We describe a double-blind randomized sham-controlled clinical trial to assess the impact of vertebroplasty on self-reported clinical outcomes in patients with painful osteoporotic vertebral compression fractures and vertebral oedema. Methods Two hundred and forty patients with painful osteoporotic vertebral fractures and MRI verified oedema will be randomized in a prospective, double-blind, single-center, clinical trial to either vertebroplasty or a sham procedure, with the possibility of crossover 12 weeks after randomization and operation. The primary outcome will be difference in self-reported pain 12 weeks after treatment between the vertebroplasty and sham group. Secondary outcomes will be patient-reported disability, health-related quality of life, societal costs of treatment and complications. Analysis will be based on intention-to-treat. Repeated measures ANCOVA with baseline ODI, Numerical Pain Rating Scale, EQ-5D-5 L, and number of levels involved as co-variates will be performed. Discussion With an aging population, the prevalence of osteoporosis and related complications such as vertebral compression fractures is expected to increase. Therefore, there is a growing need for evidence-based fracture treatments. This study fills a gap in the evidence base for treatment of painful osteoporotic vertebral fractures and will likely influence future treatment guidelines. Trial registration The study has been evaluated and approved by the Regional Committees on Health Research for Southern Denmark October 9 2023 (Projekt-ID S-20230058) and the Danish Data Protection Agency 23/40,938. The protocol has been registered at ClinicalTrials.gov with trial registration number NCT06141187 November 21, 2023.

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.

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 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.

Purpose This study aimed to investigate the effect of precooling storage of bone cement in percutaneous vertebroplasty(PVP) for the patients with osteoporotic vertebral compression fracture (OVCF). Methods A total of 207 OVCF patients who underwent PVP were included in this study. Two different storage methods for the bone cement were randomly utilized: an operating room (NT group, 23 °C) and a refrigerator (PC group, 4 °C). Clinical outcomes were evaluated using the visual analog scale (VAS) and Oswestry Disability Index (ODI) scores. In addition, radiographic evaluations were performed using anterior vertebral height and Cobb angle. Results The time of cement infusion was 10.8 ± 2.1 min in the PC group, which was significantly longer compared to the NT group (6.9 ± 1.8 min)( P  < 0.0001). However, the postoperative VAS score was lower in the PC group than the NT group ( P  < 0.0001). Moreover, compared to the NT group, the cement distribution score and rate of cement touching both upper and lower vertebral endplates were higher in the PC group ( P  < 0.0001 and = 0.037, respectively). Additionally, the anterior vertebral height was higher in the PC group compared to the NT group at both the 2-day postoperative assessment and the final follow-up ( P  = 0.046 and 0.026, respectively). Lastly, the rates of cement leakage and re-compression were lower in the PC group ( P  = 0.016 and 0.034, respectively) compared with the NT group. Conclusion Precooling storage of bone cement may prolong manipulation time in percutaneous vertebroplasty, optimize pain relief for patients, and mitigate the risk of bone cement leakage and re-compression. Trial registration Trial registration number: ChiCTR2400092330. Retrospective registration date: 14/11/2024 ( www.chictr.org.cn ).