Silver-coated versus uncoated locking plates in subjects with fractures of the distal tibia: a randomized, subject and observer-blinded, multi-center non-inferiority study.

BACKGROUND: Antimicrobial coatings of implants are of interest to reduce infection rate in orthopedic surgery. Demonstration of clinical effectiveness of such coated implants to obtain market approval is challenging. The objective of this article is to define a design for a randomized controlled trial to evaluate the clinical performance of a silver-coating for locking plates for fracture treatment. METHODS: The study design has to respect different criteria, such as feasibility, focus on overall complications, such as functional impairment, fracture healing, and particularly on infection rates. Distal tibia fractures were chosen due to the high prevalence of infections in this type of injuries, which warrants a particular benefit of antimicrobial prophylaxis and thus might allow to see a statistical trend in favor of the coated product. The study design was defined as a randomized, controlled, subject and observer-blinded, multi-center study in subjects with fractures of the distal tibia with a total of 226 patients. A number of 113 patients are planned for each of the two treatment arms with treatment of the fracture with a silver-coated device (first arm) or with an uncoated device (second arm). Inclusion criteria are closed fractures of the distal tibia according to the Tscherne-Oestern classification or open fractures of the distal tibia according to the Gustilo-Anderson classification in subjects older than 18 years. Primary outcome parameter is the Anticipated Adverse Device Effects (AADE) including all typical complications of this type of injury, such as functional impairment of the affected limb, non-union, and infections based on a non-inferiority study design. Also, silver-typical complications, such as argyria, are included. Secondary parameters are infection rates and fracture healing. Follow-up of patients includes five visits with clinical and X-ray evaluations with a follow-up time of 12 months. DISCUSSION: Demonstration of clinical effectiveness of antimicrobial coatings of fracture fixation devices remains a challenge. Definition of a prospective randomized pre-market trial design and recruitment of clinical sites for such a study is possible. A confirmative proof of the expected clinical benefit in terms of reduction of device-related infections will be addressed with a prospective post-market clinical follow-up study in a second step due to the large sample size required. TRIAL REGISTRATION: ClinicalTrials.gov NCT05260463. Registered on 02 March 2022.

Patterning-induced strain relief in single lithographic SiGe nanostructures studied by nanobeam x-ray diffraction.

The continued downscaling in SiGe heterostructures is approaching the point at which lateral confinement leads to a uniaxial strain state, giving high enhancements of the charge carrier mobility. Investigation of the strain relaxation as induced by the patterning of a continuous SiGe layer is thus of scientific and technological importance. In the present work, the strain in single lithographically defined low-dimensional SiGe structures has been directly mapped via nanobeam x-ray diffraction. We found that the nanopatterning is able to induce an anisotropic strain relaxation, leading to a conversion of the strain state from biaxial to uniaxial. Its origin is fully compatible with a pure elastic deformation of the crystal lattice without involving plastic relaxation by injection of misfit dislocations.

European research platform IPANEMA at the SOLEIL synchrotron for ancient and historical materials.

IPANEMA, a research platform devoted to ancient and historical materials (archaeology, cultural heritage, palaeontology and past environments), is currently being set up at the synchrotron facility SOLEIL (Saint-Aubin, France; SOLEIL opened to users in January 2008). The new platform is open to French, European and international users. The activities of the platform are centred on two main fields: increased support to synchrotron projects on ancient materials and methodological research. The IPANEMA team currently occupies temporary premises at SOLEIL, but the platform comprises construction of a new building that will comply with conservation and environmental standards and of a hard X-ray imaging beamline today in its conceptual design phase, named PUMA. Since 2008, the team has supported synchrotron works at SOLEIL and at European synchrotron facilities on a range of topics including pigment degradation in paintings, composition of musical instrument varnishes, and provenancing of medieval archaeological ferrous artefacts. Once the platform is fully operational, user support will primarily take place within medium-term research projects for `hosted' scientists, PhDs and post-docs. IPANEMA methodological research is focused on advanced two-dimensional/three-dimensional imaging and spectroscopy and statistical image analysis, both optimized for ancient materials.

Time-resolved microfocused small-angle X-ray scattering investigation of the microfluidic concentration of charged nanoparticles.

We describe the concentration process of a dispersion of silica nanoparticles undergoing evaporation in a dedicated microfluidic device. Using microfocused small-angle X-ray scattering, we measure in time and space both the concentration field of the dispersion and its structure factor. We show that the electrostatic interactions affect the concentration rate by strongly enhancing the collective diffusion coefficient of the nanoparticle dispersion. En route towards high concentrations, the nanoparticles eventually undergo a liquid-solid phase transition in which we evidence crystallites of micron size.

Non-destructive and quantitative imaging of a nano-structured microchip by ptychographic hard X-ray scanning microscopy.

We used hard X-ray scanning microscopy with ptychographic coherent diffraction contrast to image a front-end processed passivated microchip fabricated in 80 nm technology. No sample preparation was needed to image buried interconnects and contact layers with a spatial resolution of slightly better than 40 nm. The phase shift in the sample is obtained quantitatively. With the additional knowledge of the elemental composition determined in parallel by X-ray fluorescence mapping, quantitative information about specific nanostructures is obtained. A significant enhancement in signal-to-noise ratio and spatial resolution is achieved compared to conventional hard X-ray scanning microscopy.

Raster microdiffraction with synchrotron radiation of hydrated biopolymers with nanometre step-resolution: case study of starch granules.

X-ray radiation damage propagation is explored for hydrated starch granules in order to reduce the step resolution in raster-microdiffraction experiments to the nanometre range. Radiation damage was induced by synchrotron radiation microbeams of 5, 1 and 0.3 µm size with ∼0.1 nm wavelength in B-type potato, Canna edulis and Phajus grandifolius starch granules. A total loss of crystallinity of granules immersed in water was found at a dose of ∼1.3 photons nm(-3). The temperature dependence of radiation damage suggests that primary radiation damage prevails up to about 120 K while secondary radiation damage becomes effective at higher temperatures. Primary radiation damage remains confined to the beam track at 100 K. Propagation of radiation damage beyond the beam track at room temperature is assumed to be due to reactive species generated principally by water radiolysis induced by photoelectrons. By careful dose selection during data collection, raster scans with 500 nm step-resolution could be performed for granules immersed in water.

Radiation-induced premelting of ice at silica interfaces.

The existence of surface and interfacial melting of ice below 0 degrees C has been confirmed by many different experimental techniques. Here we present a high-energy x-ray reflectivity study of the interfacial melting of ice as a function of both temperature and x-ray irradiation dose. We found a clear increase of the thickness of the quasiliquid layer with the irradiation dose. By a systematic x-ray study, we have been able to unambiguously disentangle thermal and radiation-induced premelting phenomena. We also confirm the previously announced very high water density (1.25 g/cm(3)) within the emerging quasiliquid layer.

Coherent x-ray diffraction imaging with nanofocused illumination.

Coherent x-ray diffraction imaging is an x-ray microscopy technique with the potential of reaching spatial resolutions well beyond the diffraction limits of x-ray microscopes based on optics. However, the available coherent dose at modern x-ray sources is limited, setting practical bounds on the spatial resolution of the technique. By focusing the available coherent flux onto the sample, the spatial resolution can be improved for radiation-hard specimens. A small gold particle (size <100 nm) was illuminated with a hard x-ray nanobeam (E=15.25 keV, beam dimensions approximately 100 x 100 nm2) and is reconstructed from its coherent diffraction pattern. A resolution of about 5 nm is achieved in 600 s exposure time.

PANSS syndromes and quality of life in schizophrenia.

BACKGROUND: Results from factor analysis studies have suggested that a five-dimensional structure appears to be a better representation of the psychopathological data of the PANSS. The purpose of this study was the detailed investigation of the association of schizophrenia syndromes and single symptoms with quality of life (QOL) in acute and remitted patients. The leading hypotheses were: (1) affective symptoms, especially depression and anxiety, are mostly associated with QOL longitudinally and (2) in the acute phase, QOL is also associated with positive schizophrenia symptoms. METHODS: For the present study, schizophrenia and schizophreniform patients were studied on admission, at the end of the acute phase and 6 months after hospitalization. Psychopathology was measured using the PANSS syndromes, QOL was assessed using disease-specific (SWN) and generic (MLDL, EDLQ) scales. RESULTS: Eighty-four patients entered the study and were assessed during the acute phase taking into account their history and actual treatment. Results revealed anxiety as the most important symptom and depression as the most important syndrome associated with different areas of QOL during and after hospitalization. Also cognitive and negative symptoms were associated with different QOL domains, but both positive symptom clusters showed no substantial association with QOL. CONCLUSIONS: Results of this longitudinal study investigating psychopathology and QOL in schizophrenia provide further support for the need to consider the psychopathological state and treatment setting when measuring QOL in schizophrenia and the need for a differential analysis of schizophrenia symptoms and QOL in the acute, mid-term and long-term phase. Anxiety reduction should be a critical goal of treatment in order to prevent further QOL impairment.