Experimental Comparison between 4D Stereophotogrammetry and Inertial Measurement Unit Systems for Gait Spatiotemporal Parameters and Joint Kinematics.

(1) Background: Traditional gait assessment methods have limitations like time-consuming procedures, the requirement of skilled personnel, soft tissue artifacts, and high costs. Various 3D time scanning techniques are emerging to overcome these issues. This study compares a 3D temporal scanning system (Move4D) with an inertial motion capture system (Xsens) to evaluate their reliability and accuracy in assessing gait spatiotemporal parameters and joint kinematics. (2) Methods: This study included 13 healthy people and one hemiplegic patient, and it examined stance time, swing time, cycle time, and stride length. Statistical analysis included paired samples t-test, Bland-Altman plot, and the intraclass correlation coefficient (ICC). (3) Results: A high degree of agreement and no significant difference (p > 0.05) between the two measurement systems have been found for stance time, swing time, and cycle time. Evaluation of stride length shows a significant difference (p < 0.05) between Xsens and Move4D. The highest root-mean-square error (RMSE) was found in hip flexion/extension (RMSE = 10.99°); (4) Conclusions: The present work demonstrated that the system Move4D can estimate gait spatiotemporal parameters (gait phases duration and cycle time) and joint angles with reliability and accuracy comparable to Xsens. This study allows further innovative research using 4D (3D over time) scanning for quantitative gait assessment in clinical practice.

Healthy Ageing: A Decision-Support Algorithm for the Patient-Specific Assignment of ICT Devices and Services.

In response to rapid population ageing, digital technology represents the greatest resource in supporting the implementation of active and healthy ageing principles at clinical and service levels. However, digital information platforms that deliver coordinated health and social care services for older people to cover their needs comprehensively and adequately are still not widespread. The present work is part of a project that focuses on creating a new personalised healthcare and social assistance model to enhance older people's quality of life. This model aims to prevent acute events to favour the elderly staying healthy in their own home while reducing hospitalisations. In this context, the prompt identification of criticalities and vulnerabilities through ICT devices and services is crucial. According to the human-centred care vision, this paper proposes a decision-support algorithm for the automatic and patient-specific assignment of tailored sets of devices and local services based on adults' health and social needs. This decision-support tool, which uses a tree-like model, contains conditional control statements. Using sequences of binary divisions drives the assignation of products and services to each user. Based on many predictive factors of frailty, the algorithm aims to be efficient and time-effective. This goal is achieved by adequately combining specific features, thresholds, and constraints related to the ICT devices and patients' characteristics. The validation was carried out on 50 participants. To test the algorithm, its output was compared to clinicians' decisions during the multidimensional evaluation. The algorithm reported a high sensitivity (96% for fall monitoring and 93% for cardiac tracking) and a lower specificity (60% for fall monitoring and 27% for cardiac monitoring). Results highlight the preventive and protective behaviour of the algorithm.

Comparison of Three 3D Segmentation Software Tools for Hip Surgical Planning.

In hip arthroplasty, preoperative planning is fundamental to reaching a successful surgery. Nowadays, several software tools for computed tomography (CT) image processing are available. However, research studies comparing segmentation tools for hip surgery planning for patients affected by osteoarthritic diseases or osteoporotic fractures are still lacking. The present work compares three different software from the geometric, dimensional, and usability perspectives to identify the best three-dimensional (3D) modelling tool for the reconstruction of pathological femoral heads. Syngo.via Frontier (by Siemens Healthcare) is a medical image reading and post-processing software that allows low-skilled operators to produce prototypes. Materialise (by Mimics) is a commercial medical modelling software. 3D Slicer (by slicer.org) is an open-source development platform used in medical and biomedical fields. The 3D models reconstructed starting from the in vivo CT images of the pathological femoral head are compared with the geometries obtained from the laser scan of the in vitro bony specimens. The results show that Mimics and 3D Slicer are better for dimensional and geometric accuracy in the 3D reconstruction, while syngo.via Frontier is the easiest to use in the hospital setting.

A Procedure for Designing Custom-Made Implants for Forehead Augmentation in People Suffering from Apert Syndrome.

This paper presents a methodological procedure, based on the anatomical reconstruction and constrained deformation, to design custom-made implants for forehead augmentation in people affected by Apert syndrome, experiencing a frontal bone deficiency. According to the anthropometric theory, a cranial landmarks identification procedure was applied to retrieve, from a repository, a healthy skull, used as reference geometry for implant modelling. Then, using constrained deformation and free-form modelling techniques, it was possible to design a patient-specific implant. At last, the implant was realised using a custom mould, specially designed according to the patient's needs to provide an accurate fit of the defect site. The design procedure was tested on a patient suffering from Apert syndrome. Three implants were virtually modelled and 3D-printed for pre-surgical evaluation. Their shapes were 3D compared with a reference one (handcrafted by a surgeon) to test the accuracy. Deviations are negligible, and the customised implant fulfilled the surgeon's requirements.

Effects of Oral Appliances for Obstructive Sleep Apnoea in Reduced Periodontium: A Finite Element Analysis.

BACKGROUND AND OBJECTIVE: In the literature, no studies correlate the effects of mandibular advancement devices (MADs) with different titration systems to periodontitis. Through a finite element analysis (FEA), this study investigates the effects generated on periodontal ligaments (PDLs) and teeth by four commercial MADs in periodontal health and with 15% bone resorption. METHODS: Four MADs (Somnodent Flex™, Somnodent Avant™, Orthoapnea™, and Herbst™) were digitalised starting from the impressions of a patient's dental arches. A force of 11.18 N, representing an advancement of 9.5 mm, was applied, and a FEA was subsequently performed. After measuring the stresses and displacements on the PDLs and teeth in healthy periodontal conditions, the vertical dimension of the alveolar bone was reduced by 15%, and measurements were repeated. RESULTS: In terms of PDL stress, Herbst™ is the device which guarantees a more uniform increment in case of the first stage of periodontitis (+7% for mandibular and maxillary PDLs compared to the healthy condition). For Somnodent™ devices, the PDLs stress increment is almost null for mandibular PDLs but much higher than Herbst™ for maxillary PDLs (+17% and +21% for Flex™ and Avant™). Orthoapnea™ determines a PDL stress augmentation between the other devices (+16% and +7%, respectively, for maxillary and mandibular PDLs). Concerning teeth movement, Herbst™ and Orthoapnea™ determine a lower and more uniform displacement than Somnodent devices. CONCLUSIONS: The stress distribution and teeth displacement are strictly related to MAD geometry. Since its minor effects on teeth and PDLs, the Herbst™ could be more appropriate in patients with periodontitis.

Assessing 3-D Printing in Hip Replacement Surgical Planning.

PURPOSE: To evaluate the accuracy of 3-D printed models of the femoral head based on preoperative computed tomography (CT) images. Other goals were to compare the cartilage thickness of bony specimen to the printed models and calculate the standard deviation between 3-D printed models based on CT images and laser scan models. METHODS: This retrospective study analyzed 10 patients who underwent preoperative CT imaging and hip replacement. Preoperative femoral head 3-D printed models were produced from CT images. Bony specimens were collected from surgical operations and scanned using CT and 3-D laser scanning, and cartilage thickness subsequently was measured by histological analysis. Comparisons of printed models based on CT images and printed models based on 3-D laser scanning were performed by overlapping their external surfaces using dedicated software and the standard deviation was calculated. RESULTS: The average standard deviation between the bony specimen 3-D models and preoperative 3-D printed CT femoral head models was 0.651 mm. The cartilage was approximately 1.487 mm thick. DISCUSSION: The comparison between preoperative CT image-based 3-D models and the postoperative bony specimen-based models permitted evaluation of the accuracy of preoperative CT image-based 3-D printed models. Cartilage thickness was estimated indirectly by comparing models obtained by CT and laser scanning, and it was related to the calculated standard deviation to overcome the cartilage detection limit of CT. This study shows how each step can generate accuracy errors on the final 3-D printed model. A repeatable and sustainable workflow for creating accurate and reproducible 3-D printed models could overcome this issue. Moreover, orthopedic surgeons should be aware of 3-D printed model precision in clinical practice. CONCLUSIONS: This study provides encouraging results on the accuracy of 3-D printed models for surgical planning.

A finite element analysis for evaluating mandibular advancement devices.

Obstructive sleep apnoea (OSA) is a disorder characterised by complete or partial occlusion of the upper airway during sleep. Muscles relax during sleeping and collapse into the airway, closing the throat and prohibiting air flowing into the lungs. Different solutions have been adopted to manage the pathology to improve the life quality of affected patients. Mandibular advancement devices (MADs) are proven to be a compliant and successful therapy in the forward repositioning of the mandible to increase the upper airway volume. However, this method has some long-term adverse events that may affect the teeth and periodontal ligaments. This paper presents a finite element model to evaluate the MADs effects (displacement and stress) on teeth and periodontal ligaments, by varying the design, the point of application of the force and the material. The modelled bodies have been reconstructed through a Reverse Engineering approach and computer-aided design tools starting from tomographic images of anatomic bodies and from laser scans of a physical MAD. The results suggest that a central connection mechanism could affect mostly the anterior teeth. In contrast, a lateral connection mechanism provides a more uniform distribution of the load on teeth.

Periodontal effects of two Somnodent oral devices for the treatment of OSA: A finite element study.

OBJECTIVE: The study aims to evaluate the stresses and the deformations generated at the periodontal level by two mandibular advancement devices (MADs) using finite element analysis. METHODS: A three-dimensional digital model of the skull of a 29-year-old patient was created using a CBCT. The 3D models of two MADs (Somnodent FlexTM and Somnodent AvantTM) were reconstructed from scanning prototypes based on the patient's anatomy. The overall geometry was imported into software for the finite element study. A force of 11.18 N representing an advancement of 9.5 mm was applied to the devices. A finite element analysis wfas subsequently performed. RESULTS: Somnodent FlexTM generates a peak of 3.27 kPa on periodontal ligaments and 287 kPa on teeth. For Somnodent AvantTM the maximum stress is 4.53 kPa on periodontal ligaments and 467 kPa on teeth. CONCLUSION: Different activation mechanisms of the devices generate stresses of different entities.

A Procedure for Analyzing Mandible Roto-Translation Induced by Mandibular Advancement Devices.

BACKGROUND: Sleep-Related Breathing Disorders are characterized by repeated episodes of complete or partial obstruction of the upper airway during sleep. Mandibular advancement devices represent a non-invasive treatment in reducing the number of respiratory events and in decreasing symptoms. The advancement extent of these devices is responsible for the mandibular roto-translation and its effects on the temporomandibular joint. METHODS: This study defined a systematic method to assess the mandible roto translation that is caused by MADs according to a scan-to-CAD approach. Starting from a closed mouth position and simulating the oral appliance at different settings it was possible to define a local reference system that is useful for the evaluation of the mandibular roto-translation. This latter was then applied to evaluate the movements of the condyle and the mandibular dental arch. RESULTS: MAD1 resulted in a reduced mouth opening and protrusion, while MAD2 enabled a higher degree of motion of the mandible useful for patients who need an important protrusion. CONCLUSIONS: The two devices present different dynamics. Results that are achievable employing this method can be directly used by practitioners in comparing MADs, as well as by researchers in evaluating MADs effects.

Preliminary simulation model toward the study of the effects caused by different mandibular advancement devices in OSAS treatment.

The paper aims to evaluate the effects caused by a Mandibular Advancement Device (MAD) for Obstructive Sleep Apnoea Syndrome (OSAS) treatment. This study is based on Finite Element Method (FEM) for evaluating the load distribution on temporomandibular joint, especially on the mandibular condyle and disc, and on periodontal ligaments. The stress values on condyle and periodontal ligaments lead authors to consider MAD a safe procedure even for a long period. The obtained results also show the relationship between MAD material and load distribution at the periodontal ligaments. The paper is a step toward future analyses for studying and comparing the effects of MAD features, such as material, shape and dimensions, in order to allow the clinician prescribing the most fitting device.

Ex vivo encapsulation of dexamethasone sodium phosphate into human autologous erythrocytes using fully automated biomedical equipment.

Erythrocyte-based drug delivery systems are emerging as potential new solutions for the release of drugs into the bloodstream. The aim of the present work was to assess the performance of a fully automated process (EDS) for the ex-vivo encapsulation of the pro-drug dexamethasone sodium phosphate (DSP) into autologous erythrocytes in compliance with regulatory requirements. The loading method was based on reversible hypotonic hemolysis, which allows the opening of transient pores in the cell membrane to be crossed by DSP. The efficiency of encapsulation and the biochemical and physiological characteristics of the processed erythrocytes were investigated in blood samples from 34 healthy donors. It was found that the processed erythrocytes maintained their fundamental properties and the encapsulation process was reproducible. The EDS under study showed greater loading efficiency and reduced variability compared to previous EDS versions. Notably, these results were confirmed using blood samples from Ataxia Telangiectasia (AT) patients, 9.33±1.40 and 19.41±2.10mg of DSP (mean±SD, n=134) by using 62.5 and 125mg DSP loading quantities, respectively. These results support the use of the new EDS version 3.2.0 to investigate the effect of erythrocyte-delivered dexamethasone in regulatory trials in patients with AT.

Elaboration of a reliable strategy based on real-time PCR to characterize genetically modified plantlets and to evaluate the efficiency of a marker gene removal in grape (Vitis spp.).

We have developed an effective strategy based on real-time PCR assay for the molecular characterization of genetically modified grape and to quantify the efficiency of a marker gene removal. This research has been implemented in Vitis vinifera cv. Brachetto plantlets where exogenes were inserted during cocultures of embryogenic calli with Agrobacterium tumefaciens carrying the chemically inducible site-specific cre/loxP pX6 vector where the expression of the cre recombinase is regulated by 17-beta-estradiol. The neomycin phosphotransferase gene (nptII) for the kanamycin resistance trait was inserted as part of the gene transfer protocol, and this exogene was employed as a case study for carrying out our research. The 9-cis-epoxycarotenoid dioxygenase (nced2) and chalcone isomerase (chi) genes coding for two enzymes, involved respectively in abscisic acid and flavonoid biosynthesis, proved to be valuable reference endogenes for real-time PCR assays. Two types of duplo-target plasmids were exploited for building the standard curves: in one type (p-nptII/nced2) the nptII sequence is linked to the nced2 sequence; in the other (p-nptII/chi) it is linked to the chi. These calibrators were intended to simulate an ideal genetically modified plant carrying a homozygous single-copy exogene insertion. The repeatability test confirmed the suitability of both plasmid calibrators. Foreign gene stability can be monitored during long-term plant preservation, and the method proved to be suitable for quantifying the efficiency of nptII gene removal induced by 17-beta-estradiol.