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

Homeotic Evolution in the Mammalia: Diversification of Therian Axial Seriation and the Morphogenetic Basis of Human Origins

Despite the rising interest in homeotic genes, little has been known about the course and pattern of evolution of homeotic traits across the mammalian radiation. An array of emerging and diversifying homeotic gradients revealed by this study appear to generate new body plans and drive evolution at a large scale.This study identifies and evaluates a set of homeotic gradients across 250 extant and fossil mammalian species and their antecedents over a period of 220 million years. These traits are generally expressed as co-linear gradients along the body axis rather than as distinct segmental identities. Relative position or occurrence sequence vary independently and are subject to polarity reversal and mirroring. Five major gradient modification sets are identified: (1)--quantitative changes of primary segmental identity pattern that appeared at the origin of the tetrapods ; (2)--frame shift relation of costal and vertebral identity which diversifies from the time of amniote origins; (3)--duplication, mirroring, splitting and diversification of the neomorphic laminar process first commencing at the dawn of mammals; (4)--emergence of homologically variable lumbar lateral processes upon commencement of the radiation of therian mammals and ; (5)--inflexions and transpositions of the relative position of the horizontal septum of the body and the neuraxis at the emergence of various orders of therian mammals. Convergent functional changes under homeotic control include laminar articular engagement with septo-neural transposition and ventrally arrayed lumbar transverse process support systems.Clusters of homeotic transformations mark the emergence point of mammals in the Triassic and the radiation of therians in the Cretaceous. A cluster of homeotic changes in the Miocene hominoid Morotopithecus that are still seen in humans supports establishment of a new "hominiform" clade and suggests a homeotic origin for the human upright body plan

Fast changes of corneal curvature distribution during non-contact examination using corvis st tonometer - numerical analysis

Kształt rogówki oka wpływa bezpośrednio na właściwości optyczne oka oraz na jakość widzenia. Geometria przedniej powierzchni rogówki, a głównie rozkład jej promieni krzywizn, jest uwarunkowana przez wartość ciśnienia wewnątrzgałkowego oraz przez osobniczo zmienne właściwości biomechaniczne przedniego odcinka oka. Właściwości te mają wpływ na pomiar tonometryczny ciśnienia wewnątrzgałkowego. W pracy używano nowoczesnego, bezkontaktowego tonometru Corvis ST. Urządzenie to pozwala na rejestrację bardzo szybkich zmian kształtu poziomego profilu rogówki wywołanych impulsem strumienia powietrza. Celem niniejszej pracy jest analiza szybkich zmian rozkładu krzywizny profilu rogówki w czasie wywołanych podmuchem powietrza, wykonana na podstawie sekwencji zdjęć uzyskanych z tonometru Corvis ST. W badaniu uczestniczyło dziesięciu zdrowych ochotników. Każdy z nich został poddany serii 9 pomiarów na jedno oko. Uzyskane sekwencje zdjęć przeanalizowano numerycznie za pomocą pakietu Matlab. Czasowo-przestrzenne rozkłady krzywizny wyzna-czono na podstawie dwóch metod wygładzania krawędzi rogówki: funkcją wielomianową oraz filtrem gaussowskim. Następnie wyznaczono szereg parametrów opisujących krzywiznę i jej rozkład oraz poddano je analizie statystycznej pod kątem powtarzalności dla poszczególnego pacjenta.The shape of the cornea has a direct impact on the optical properties of the eye and vision quality. The geometry of the anterior surface of the cornea and its curvature distribution is determined by the value of the intraocular pressure (IOP) and by individual biomechanical properties of the anterior segment of the eye. These properties influence measurement of IOP. The impact of these properties can be observed during the IOP examination. In this study, the modern, non-contact Corvis ST tonometer was used. This device records ultra-fast changes in the shape of a horizontal profile of the cornea, which are caused by air blast. Our purpose was to numerically analyze changes of the corneal profile curvature distributions, which occur during deformation caused by an air-puff tonometric examination. Ten healthy volunteers were examined using the Corvis ST. One eye of each subject was measured nine times. On the basis of two different smoothening methods (polynomial fitting and gaussian filtering), time-spatial distributions of corneal curvature profiles were obtained. Further, a number of parameters describing these distributions was calculated and statistically analyzed in terms of reproducibility for the individual patient

Spine surgery training and competence of European Neurosurgical Trainees

Little is known about the nature of spine surgery training received by European neurosurgical trainees during their residency and the level of competence they acquire in dealing with spinal disorders. A three-part questionnaire entailing 32 questions was devised and distributed to the neurosurgical trainees attending the EANS (European Association of Neurosurgical Societies) training courses of 2004. Of 126 questionnaires, 32% were returned. The majority of trainees responding to the questionnaire were in their final (6(th)) year of training or had completed their training (60.3% of total). Spinal surgery training in European residency programs has clear strengths in the traditional areas of microsurgical decompression for spinal stenosis and disc herniation (77-90% competence in senior trainees). Deficits are revealed in the management of spinal trauma (34-48% competence in senior trainees) and spinal conditions requiring the use of implants and anterior approaches, with the exception of anterior cervical stabilisation. European neurosurgical trainees possess incomplete competence in dealing with spinal disorders. EANS trainees advocate the development of a postresidency spine subspecialty training program

Clinical outcomes of sacroplasty in sacral insufficiency fractures: a review of the literature

Sacral insufficiency fractures (SIFs) are an increasingly recognised cause of back pain in the elderly. They can cause significant pain and disability in the elderly population and until recently, the mainstay of treatment has been analgesia and physical therapy. We undertook a review of the literature looking at the outcome with various operative techniques currently used in the treatment of SIF. A thorough literature search was undertaken to identify the various techniques used in the surgical treatment of SIF and their outcome. Keywords used included sacroplasty, SIF and cement augmentation. We analysed the number of cases presented, surgical technique, follow-up and clinical outcome. The techniques described include sacroplasty (injection of cement into fractured sacrum) and augmented iliosacral (trans-sacral) screws. Fifteen papers were published in the English literature between 2002 and 2008. No Level I, II or III evidence was available. In total, 108 patients were included. Computerised tomography combined with fluoroscopy was the most common image guidance technique used (80 patients). Where documented, there was significant improvement in mean visual analogue score (VAS) from 8.9 to 2.6 (P < 0.001, paired Student’s t test). In conclusion, cement augmentation techniques such as sacroplasty with or without iliosacral screw fixation can produce significant improvements in VAS scores. They appear to be a suitable alternative to analgesia and rehabilitation. However, more robust evidence is required to validate these promising early results with cement augmentation techniques