Predictive factors for sustained pain after (sub)acute osteoporotic vertebral fractures:Combined results from the VERTOS II and VERTOS IV trial

PURPOSE: Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials. METHODS: The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (≥ 5) versus low ( 8, long-term baseline pain, mild/severe Genant and new fractures. CONCLUSIONS: Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00270-022-03170-7

A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

<p>Abstract</p> <p>Background</p> <p>The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) found effective pain relief at acceptable costs. The objective of this study is to compare pain relief after PV with a sham intervention in selected patients with an acute osteoporotic VCF using the same strict inclusion criteria as in VERTOS II. Secondary outcome measures are back pain related disability and quality of life.</p> <p>Methods</p> <p>The VERTOS IV study is a prospective, multicenter RCT with pain relief as primary endpoint. Patients with a painful osteoporotic VCF with bone edema on MR imaging, local back pain for 6 weeks or less, osteopenia and aged 50 years or older, after obtaining informed consent, are included and randomized for PV or a sham intervention. In total 180 patients will be enrolled. Follow-up is at regular intervals during a 1-year period with a standard Visual Analogue Scale (VAS) score for pain and pain medication. Necessary additional therapies and complications are recorded.</p> <p>Discussion</p> <p>The VERTOS IV study is a methodologically sound RCT designed to assess pain relief after PV compared to a sham intervention in patients with an acute osteoporotic VCF selected on strict inclusion criteria.</p> <p>Trial registration</p> <p>This study is registered at ClinicalTrials.gov., <a href="http://www.clinicaltrials.gov/ct2/show/NCT01200277">NCT01200277</a>.</p

Increasing involvement of CAPN1 variants in spastic ataxias and phenotype-genotype correlations

Spastic ataxias are rare neurogenetic disorders involving spinocerebellar and pyramidal tracts. Many genes are involved. Among them, CAPN1, when mutated, is responsible for a complex inherited form of spastic paraplegia (SPG76). We report the largest published series of 21 novel patients with nine new CAPN1 disease-causing variants and their clinical characteristics from two European university hospitals (Paris and Stockholm). After a formal clinical examination, causative variants were identified by next-generation sequencing and confirmed by Sanger sequencing. CAPN1 variants are a rare cause (~ 1.4%) of young-adult-onset spastic ataxia; however, together with all published cases, they allowed us to better describe the clinical and genetic spectra of this form. Truncating variants are the most frequent, and missense variants lead to earlier age at onset in favor of an additional deleterious effect. Cerebellar ataxia with cerebellar atrophy, dysarthria and lower limb weakness are often associated with spasticity. We also suggest that cognitive impairment and depression should be assessed specifically in the follow-up of SPG76 cases.Identification of new causative genes in spinocerebellar degenerations by combination of whole genome scan, next-generation sequencing and biological validation in vitro and in vivoInfrastructure de Recherche Translationnelle pour les Biothérapies en NeurosciencesEuropean Union’s Horizon 2020 research and innovation programm

Studies on Arabic Dialectology and Sociolinguistics

This volume contains over fifty articles related to various fields of modern Arabic dialectology. All the articles are revised and enhanced versions of papers read on the 12th Conference of the Association Internationale de Dialectologie Arabe (AIDA) held in Marseille in June 2017. Since its first conference in Paris in 1993, AIDA members gather every two years in different country. The collection of the AIDA proceedings offer an updated insight of the development of the field. During the past few decadesthe the study of Arabic dialects has become an important branch of research covering a wide range of subjects from phonological analyses, morphosyntax, semantics to pragmatics, sociolinguistics, folk linguistics, studies on literacy and writings, cultural and artistic practices, etc. As many articles of this volume illustrate, the study of Arabic dialects explores different aspects of the languages and cultures of the contemporary Arab world. A remarkable feature is the growing and constant participation of young scholars from all around the globe

Peripheral vascular disease as a predictor of survival after coronary artery bypass grafting: comparison with a matched general population

BACKGROUND: Preoperative left ventricular dysfunction is an established risk factor for early and late mortality after revascularization. This retrospective analysis demonstrates the effects of preoperative ejection fraction on the short-term and long-term survival of patients after coronary artery bypass grafting. METHODS: Early and late mortality were determined retrospectively in 10 626 consecutive patients who underwent isolated coronary bypass between January 1998 and December 2007. The subjects were divided into 3 groups according to their preoperative ejection fraction. Expected survival was estimated by comparison with a general Dutch population group described in the database of the Dutch Central Bureau for Statistics. For each of our groups with a known preoperative ejection fraction, a general Dutch population group was matched for age, sex, and year of operation. RESULTS AND DISCUSSION: One hundred twenty-two patients were lost to follow-up. In 219 patients, the preoperative ejection fraction could not be retrieved. In the remaining patients (n = 10 285), the results of multivariate logistic regression and Cox regression analysis identified the ejection fraction as a predictor of early and late mortality. When we compared long-term survival and expected survival, we found a relatively poorer outcome in all subjects with an ejection fraction of < 50%. In subjects with a preoperative ejection fraction of > 50%, long-term survival exceeded expected survival. CONCLUSIONS: The severity of left ventricular dysfunction was associated with poor survival. Compared with the survival of the matched general population, our coronary bypass patients had a worse outcome only if their preoperative ejection fraction was < 50%

Predictive factors for sustained pain after (sub)acute osteoporotic vertebral fractures: Combined results from the VERTOS II and VERTOS IV trial

Purpose Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials. Methods The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (>= 5) versus low (= 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (chi(2)(1) = 15.26, p = 5 after 12 months follow-up), namely: female, baseline VAS > 8, long-term baseline pain, mild/severe Genant and new fractures. Conclusions Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy

Percutaneous vertebroplasty is no risk factor for new vertebral fractures and protects against further height loss (VERTOS IV)

Background: Percutaneous 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. Mehods: VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. NewOVCFs and further vertebral height loss were assessed at 3, 6, and 12 months. Results: After 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. Conclusions: The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protectsagainst progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs