Search results for: Xen45 gel implant

Authors: Werner Grommes

Abstract:

The institute of occupational safety and health works in a working group for building a normative standard for illuminated warning vests and did a lot of experiments and measurements as basic work (cooperation). Intelligent car headlamps are able to suppress conventional warning vests with retro-reflective stripes as a disturbing light. Illuminated warning vests are therefore required for occupational safety. However, they must not pose any danger to the wearer or other persons. Here, the risks of the batteries (lithium types), the maximum brightness (glare) and possible interference radiation from the electronics on the implant carrier must be taken into account. The all-around visibility, as well as the required range, play an important role here. For the study, many luminance measurements of already commercially available LEDs and electroluminescent warning vests, as well as their electromagnetic interference fields and aspects of electrical safety, were measured. The results of this study showed that LED lighting is all far too bright and causes strong glare. The integrated controls with pulse modulation and switching regulators cause electromagnetic interference fields. Rechargeable lithium batteries can explode depending on the temperature range. Electroluminescence brings even more hazards. A test method was developed for the evaluation of visibility at distances of 50, 100, and 150 m, including the interview of test persons. A measuring method was developed for the detection of glare effects at close range with the assignment of the maximum permissible luminance. The electromagnetic interference fields were tested in the time and frequency ranges. A risk and hazard analysis were prepared for the use of lithium batteries. The range of values for luminance and risk analysis for lithium batteries were discussed in the standards working group. These will be integrated into the standard. This paper gives a brief overview of the topics of illuminated warning vests, which takes into account the risks and hazards for the vest wearer or others

Keywords: illuminated warning vest, optical tests and measurements, risks, hazards, optical glare effects, LED, E-light, electric luminescent

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Authors: Keerthilatha Pai, Sakshi Kamra

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Objectives: Determining the position of the mandibular canal prior to implant placement and surgeries of the posterior mandible are important to avoid the nerve injury. The visibility of the mandibular canal varies according to the imaging modality. Although panoramic radiography is the most common, slowly cone beam computed tomography is replacing it. This study was conducted with an aim to determine and compare the visibility of superior and inferior borders of the mandibular canal in digital panoramic radiograph, reformatted panoramic radiograph and cross-sectional images of cone beam computed tomography. Study design: digital panoramic, reformatted panoramic radiograph and cross sectional CBCT images of 25 human mandibles were evaluated for the visibility of the superior and inferior borders of the mandibular canal according to a 5 point scoring criteria. Also, the canal was evaluated as completely visible, partially visible and not visible. The mean scores and visibility percentage of all the imaging modalities were determined and compared. The interobserver and intraobserver agreement in the visualization of the superior and inferior borders of the mandibular canal were determined. Results: The superior and inferior borders of the mandibular canal were completely visible in 47% of the samples in digital panoramic, 63% in reformatted panoramic and 75.6% in CBCT cross-sectional images. The mandibular canal was invisible in 24% of samples in digital panoramic, 19% in reformatted panoramic and 2% in cross-sectional CBCT images. Maximum visibility was seen in Zone 5 and least visibility in Zone 1. On comparison of all the imaging modalities, CBCT cross-sectional images showed better visibility of superior border in Zones 2,3,4,6 and inferior border in Zones 2,3,4,6. The difference was statistically significant. Conclusion: CBCT cross-sectional images were much superior in the visualization of the mandibular canal in comparison to reformatted and digital panoramic radiographs. The inferior border was better visualized in comparison to the superior border in digital panoramic imaging. The mandibular canal was maximumly visible in posterior one-third region of the mandible and the visibility decreased towards the mental foramen.

Keywords: cone beam computed tomography, mandibular canal, reformatted panoramic radiograph, visualization

Procedia PDF Downloads 127

Authors: Mike T. Wei, Douglas N. Mintz, Lisa A. Mandl, Arielle W. Fein, Jayme C. Burket, Yuo-Yu Lee, Wei-Ti Huang, Vivian P. Bykerk, Mark P. Figgie, Edward F. Di Carlo, Bruce N. Cronstein, Susan M. Goodman

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Background/Purpose: Rheumatoid arthritis (RA) patients have excellent total hip arthroplasty (THA) survival, and methotrexate (MTX), an anti-inflammatory disease modifying drug which may affect bone reabsorption, may play a role. The purpose of this study is to determine the diagnosis leading to revision THA (rTHA) in RA patients and to assess the association of radiographic lucency with MTX use. Methods: All patients with validated diagnosis of RA in the institution’s THA registry undergoing rTHA from May 2007 - February 2011 were eligible. Diagnosis leading to rTHA and medication use was determined by chart review. Osteolysis was evaluated on available radiographs by measuring maximum lucency in each Gruen zone. Differences within RA patients with/without MTX in osteolysis, demographics, and medications were assessed with chi-squared, Fisher's exact tests or Mann-Whitney U tests as appropriate. The error rate for multiple comparisons of lucency in the different Gruen zones was corrected via false discovery rate methods. A secondary analysis was performed to determine differences in diagnoses leading to revision between RA and matched OA controls (2:1 match by sex age +/- 5 years). OA exclusion criteria included presence of rheumatic diseases, use of MTX, and lack of records. Results: 51 RA rTHA were identified and compared with 103 OA. Mean age for RA was 57.7 v 59.4 years for OA (p = 0.240). 82.4% RA were female v 83.5% OA (p = 0.859). RA had lower BMI than OA (25.5 v 28.2; p = 0.166). There was no difference in diagnosis leading to rTHA, including infection (RA 3.9 v OA 6.8%; p = 0.719) or dislocation (RA 23.5 v OA 23.3%; p = 0.975). There was no significant difference in the length of time the implant was in before revision: RA 11.0 v OA 8.8 years (p = 0.060). Among RA with/without MTX, there was no difference in use of biologics (30.0 v 43.3%, p = 0.283), steroids (47.6 v 50.0%, p = 0.867) or bisphosphonates (23.8 v 33.3%, p = 0.543). There was no difference in rTHA diagnosis with/without MTX, including loosening (52.4 v 56.7%, p = 0.762). There was no significant difference in lucencies with MTX use in any Gruen zone. Patients with MTX had femoral stem subsidence of 3.7mm v no subsidence without MTX (p = 0.006). Conclusion: There was no difference in the diagnosis leading to rTHR in RA and OA, although RA trended longer prior to rTHA. In this small retrospective study, there were no significant differences associated with MTX exposure or radiographic lucency among RA patients. The significance of subsidence is not clear. Further study of arthroplasty survival in RA patients is warranted.

Keywords: hip arthroplasty, methotrexate, revision arthroplasty, rheumatoid arthritis

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Authors: C. Busuioc, I. Stancu, A. Nicoara, A. Zamfirescu, A. Evanghelidis

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The field of tissue engineering has expanded its potential due to the use of composite biomaterials belonging to increasingly complex systems, leading to bone substitutes with properties that are continuously improving to meet the patient's specific needs. Furthermore, the development of biomaterials based on ceramic and polymeric phases is an unlimited resource for future scientific research, with the final aim of restoring the original tissue functionality. Thus, in the first stage, composite scaffolds based on polycaprolactone (PCL) or polylactic acid (PLA) and inorganic powders were prepared by employing the electrospinning technique. The targeted powders were: commercial and laboratory synthesized hydroxyapatite (HAp), as well as barium titanate (BT). By controlling the concentration of the powder within the precursor solution, together with the processing parameters, different types of three-dimensional architectures were achieved. In the second stage, both the mineral powders and hybrid composites were investigated in terms of composition, crystalline structure, and microstructure so that to demonstrate their suitability for tissue engineering applications. Regarding the scaffolds, these were proven to be homogeneous on large areas and loaded with mineral particles in different proportions. The biological assays demonstrated that the addition of inorganic powders leads to modified responses in the presence of simulated body fluid (SBF) or cell cultures. Through SBF immersion, the biodegradability coupled with bioactivity were highlighted, with fiber fragmentation and surface degradation, as well as apatite layer formation within the testing period. Moreover, the final composites represent supports accepted by the cells, favoring implant integration. Concluding, the purposed fibrous materials based on bioresorbable polymers and mineral powders, produced by the electrospinning technique, represent candidates with considerable potential in the field of tissue engineering. Future improvements can be attained by optimizing the synthesis process or by simultaneous incorporation of multiple inorganic phases with well-defined biological action in order to fabricate multifunctional composites.

Keywords: barium titanate, electrospinning, fibre networks, hydroxyapatite, smart scaffolds

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Authors: Gulsharat A. Baigonakova, Ekaterina S. Marchenko, Venera R. Luchsheva

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The preferred materials for bone grafting are titanium-nickel alloys. They have a porous, permeable structure similar to that of bone tissue, can withstand long-term physiological stress in the body, and retain the scaffolding function for bone tissue ingrowth. Despite the excellent functional properties of these alloys, there is a possibility of post-operative infectious complications that prevent the newly formed bone tissue from filling the spaces created in a timely manner and prolong the rehabilitation period of patients. In order to minimise such consequences, it is necessary to use biocompatible materials capable of simultaneously fulfilling the function of a long-term functioning implant and an osteoreplacement carrier saturated with drugs. Methods to modify the surface by saturation with bioactive substances, in particular macrocyclic compounds, for the controlled release of drugs, biologically active substances, and cells are becoming increasingly important. This work is dedicated to the functionalisation of the surface of porous titanium nickelide by the deposition of macrocyclic compounds in order to provide titanium nickelide with antibacterial activity and accelerated osteogenesis. The paper evaluates the effect of macrocyclic compound deposition methods on the continuity, structure, and cytocompatibility of the surface properties of porous titanium nickelide. Macrocyclic compounds were deposited on the porous surface of titanium nickelide under the influence of various physical effects. Structural research methods have allowed the evaluation of the surface morphology of titanium nickelide and the nature of the distribution of these compounds. The method of surface functionalisation of titanium nickelide influences the size of the deposited bioactive molecules and the nature of their distribution. The surface functionalisation method developed has enabled titanium nickelide to be deposited uniformly on the inner and outer surfaces of the pores, which will subsequently enable the material to be uniformly saturated with various drugs, including antibiotics and inhibitors. The surface-modified porous titanium nickelide showed high biocompatibility and low cytotoxicity in in vitro studies. The research was carried out with financial support from the Russian Science Foundation under Grant No. 22-72-10037.

Keywords: biocompatibility, NiTi, surface, porous structure

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Authors: Olivera Lupescu, Taina Elena Avramescu, Mihail Nagea, Alexandru Dimitriu

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Acetabular fractures represent a real challenge due to their impact upon the long term function of the hip joint, and due to the risk of intra- and peri-operative complications especially that they affect young, active people. That is why treating these fractures require certain skills which must be exercised, regarding the pre-operative planning, as well as the execution of surgery.The authors retrospectively analyse 38 cases with acetabular fractures operated using the posterior approach in our hospital between 01.01.2013- 01.01.2015 for which complete medical records ensure a follow-up of 24 months, in order to establish the main causes of potential errors and to underline the methods for preventing them. This target is included in the Erasmus + project ‘Collaborative learning for enhancing practical skills for patient-focused interventions in gait rehabilitation after orthopedic surgery COR-skills’. This paper analyses the pitfalls revealed by these cases, as well as the measures necessary to enhance the practical skills of the surgeons who perform acetabular surgery. Pre-op planning matched the intra and post-operative outcome in 88% of the analyzed points, from 72% at the beginning to 94% in the last case, meaning that experience is very important in treating this injury. The main problems detected for the posterior approach were: nervous complications - 3 cases, 1 of them a complete paralysis of the sciatic nerve, which recovered 6 months after surgery, and in other 2 cases intra-articular position of the screws was demonstrated by post-operative CT scans, so secondary screw removal was necessary in these cases. We analysed this incident, too, due to lack of information about the relationship between the screws and the joint secondary to this approach. Septic complications appeared in 3 cases, 2 superficial and 1 profound (requiring implant removal). The most important problems were the reduction of the fractures and the positioning of the screws so as not to interfere with the the articular space. In posterior acetabular fractures, pre-op complex planning is important in order to achieve maximum treatment efficacy with minimum of risk; an optimal training of the surgeons insisting on the main points of potential mistakes ensure the success of the procedure, as well as a favorable outcome for the patient.

Keywords: acetabular fractures, articular congruency, surgical skills, vocational training

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Authors: Irene Buj-Corral, Ali Bagheri, Alejandro Dominguez-Fernandez

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In recent years, use of ceramic prostheses as an implant in some parts of body has become common. In the present study, research has focused on replacement of the acetabulum bone, which is a part of the pelvis bone. Metallic prostheses have shown some problems such as release of metal ions into patient's blood. In addition, fracture of liners and squeezing between surface of femoral head and inner surface of acetabulum have been reported. Ceramic prostheses have the advantage of low debris and high strength, although they are more difficult to be manufactured than metallic ones. Specifically, new designs try to attempt an acetabulum in which the outer surface will be porous for proliferation of cells and fixation of the prostheses by means of osteointegration, while inner surface must be smooth enough to assure that the movement between femoral head and inner surface will be carried out with on feasibility. In the present study, 3D printing technologies are used for manufacturing ceramic prostheses. In Fused Deposition Modelling (FDM) process, 3D printed plastic prostheses are obtained by means of melting of a plastic filament and subsequent deposition on a glass surface. A similar process is applied to ceramics in which ceramic powders need to be mixed with a liquid polymer before depositing them. After 3D printing, parts are subjected to a sintering process in an oven so that they can achieve final strength. In the present paper, influence of printing parameters on surface roughness 3D printed ceramic parts are presented. Three parameter full factorial design of experiments was used. Selected variables were layer height, infill and nozzle diameter. Responses were average roughness Ra and mean roughness depth Rz. Regression analysis was applied to responses in order to obtain mathematical models for responses. Results showed that surface roughness depends mainly on layer height and nozzle diameter employed, while infill was found not to be significant. In order to get low surface roughness, low layer height and low infill should be selected. As a conclusion, layer height and infill are important parameters for obtaining good surface finish in ceramic 3D printed prostheses. However, use of too low infill could lead to prostheses with low mechanical strength. Such prostheses could not be able to bear the static and dynamic charges to which they are subjected once they are implanted in the body. This issue will be addressed in further research.

Keywords: ceramic, hip prostheses, surface roughness, 3D printing

Procedia PDF Downloads 197

Authors: Geliashvili T. M., Tyulyandina A. S., Valiev A. K., Kononets P. V., Kharatishvili T. K., Salkov A. G., Pronin A. I., Gadzhieva E. H., Parnas A. V., Ilyakov V. S.

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Aim/Introduction: Metastasis (Mts) to the sternum, while extremely rare in differentiated thyroid cancer (DTC) (1), requires a personalized, multidisciplinary treatment approach. In aggressively growing Mts to the sternum, which rapidly become unresectable, a comprehensive therapeutic and diagnostic approach is particularly important. Materials and methods: We present a clinical case of solitary Mts to the sternum as first manifestation of a papillary thyroid microcarcinoma in a 55-year-old man. Results: 18F-FDG PET/CT after thyroidectomy confirmed the solitary Mts to the sternum with extremely high FDG uptake (SUVmax=71,1), which predicted its radioiodine-refractory (RIR). Due to close attachment to the mediastinum and rapid growth, Mts was considered unresectable. During the next three months, the patient received targeted therapy with the tyrosine kinase inhibitor (TKI) Lenvatinib 24 mg per day. 1st course of radioiodine therapy (RIT) 6 GBq was also performed, the results of which confirmed the RIR of the tumor process. As a result of systemic therapy (targeted therapy combined with RIT and suppressive hormone therapy with L-thyroxine), there was a significant biochemical response (decrease of serum thyroglobulin level from 50,000 ng/ml to 550 ng/ml) and a partial response with decrease of tumor size (from 80x69x123 mm to 65x50x112 mm) and decrease of FDG accumulation (SUVmax from 71.1 to 63). All of this made possible to perform surgical treatment of Mts - sternal extirpation with its replacement by an individual titanium implant. At the control examination, the stimulated thyroglobulin level was only 134 ng/ml, and PET/CT revealed postoperative areas of 18F-FDG metabolism in the removed sternal Mts. Also, 18F-FDG PET/CT in the early (metabolic) stage revealed two new bone Mts (in the area of L3 SUVmax=17,32 and right iliac bone SUVmax=13,73), which, as well as the removed sternal Mts, appeared to be RIRs at the 2nd course of RIT 6 GBq. Subsequently, on 02.2022, external beam radiation therapy (EBRT) was performed on the newly identified oligometastatic bone foci. At present, the patient is under dynamic monitoring and in the process of suppressive hormone therapy with L-thyroxine. Conclusion: Thus, only due to the early prescription of targeted TKI therapy was it possible to perform surgical resection of Mts to the sternum, thereby improve the patient's quality of life and preserve the possibility of radical treatment in case of oligometastatic disease progression.

Keywords: differentiated thyroid cancer, metastasis to the sternum, radioiodine therapy, radioiodine-refractory cancer, targeted therapy, lenvatinib

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Authors: Benjawan Saengwichian, Alasdair E. Charles, Philip J. Hyde

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Magnetically controlled growing rods (MCGRs) have been used to stabilise and correct spinal curvature in children to support non-invasive scoliosis adjustment. Although the encapsulated driving components are intended to be isolated from body fluid contact, in vivo corrosion was observed on these components due to sealing mechanism damage. Consequently, a corrosion circuit is created with the body fluids, resulting in malfunction of the lengthening mechanism. Particularly, the chloride ions in blood plasma or cerebrospinal fluid (CSF) may corrode the MCGR alloys, possibly resulting in metal ion release in long-term use. However, there is no data available on the corrosion resistance of spinal implant alloys in CSF. In this study, an in vitro immersion configuration was designed to simulate in vivo corrosion of 440C SS-Ti6Al4V couples. The 440C stainless steel (SS) was heat-treated to investigate the effect of tempering temperature on intergranular corrosion (IGC), while crevice and galvanic corrosion were studied by limiting the clearance of dissimilar couples. Tests were carried out in a neutral artificial cerebrospinal fluid (ACSF) and phosphate-buffered saline (PBS) under aeration and deaeration for 2 months. The composition of the passive films and metal ion release were analysed. The effect of galvanic coupling, pH, dissolved oxygen and anion species on corrosion rates and corrosion mechanisms are discussed based on quantitative and qualitative measurements. The results suggest that ACSF is more aggressive than PBS due to the combination of aggressive chlorides and sulphate anions, while phosphate in PBS acts as an inhibitor to delay corrosion. The presence of Vivianite on the SS surface in PBS lowered the corrosion rate (CR) more than 5 times for aeration and nearly 2 times for deaeration, compared with ACSF. The CR of 440C is dependent on passive film properties varied by tempering temperature and anion species. Although the CR of Ti6Al4V is insignificant, it tends to release more Ti ions in deaerated ACSF than under aeration, about 6 µg/L. It seems the crevice-like design has more effect on macroscopic corrosion than combining the dissimilar couple, whereas IGC is dominantly observed on sensitized microstructure.

Keywords: cerebrospinal fluid, crevice corrosion, intergranular corrosion, magnetically controlled growing rods

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Authors: Werner Grommes

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Intelligent wearables (illuminated vests or hand and foot-bands, smart watches with a laser diode, Bluetooth smart glasses) overflow the market today. They are integrated with complex electronics and are worn very close to the body. Optical measurements and limitation of the maximum light density are needed. Smart watches are equipped with a laser diode or control different body currents. Special glasses generate readable text information that is received via radio transmission. Small high-performance batteries (lithium-ion/polymer) supply the electronics. All these products have been tested and evaluated for risk. These products must, for example, meet the requirements for electromagnetic compatibility as well as the requirements for electromagnetic fields affecting humans or implant wearers. Extensive analyses and measurements were carried out for this purpose. Many users are not aware of these risks. The result of this study should serve as a suggestion to do it better in the future or simply to point out these risks. Commercial LED warning vests, LED hand and foot-bands, illuminated surfaces with inverter (high voltage), flashlights, smart watches, and Bluetooth smart glasses were checked for risks. The luminance, the electromagnetic emissions in the low-frequency as well as in the high-frequency range, audible noises, and nervous flashing frequencies were checked by measurements and analyzed. Rechargeable lithium-ion or lithium-polymer batteries can burn or explode under special conditions like overheating, overcharging, deep discharge or using out of the temperature specification. Some risk analysis becomes necessary. The result of this study is that many smart wearables are worn very close to the body, and an extensive risk analysis becomes necessary. Wearers of active implants like a pacemaker or implantable cardiac defibrillator must be considered. If the wearable electronics include switching regulators or inverter circuits, active medical implants in the near field can be disturbed. A risk analysis is necessary.

Keywords: safety and hazards, electrical safety, EMC, EMF, active medical implants, optical radiation, illuminated warning vest, electric luminescent, hand and head lamps, LED, e-light, safety batteries, light density, optical glare effects

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Authors: Vishwanath Mali, Hemant Warhatkar, Raju Pawade

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Drilling of bone has been always challenging for surgeons due to the adverse effect it may impart to bone tissues. Force has to be applied manually by the surgeon while performing conventional bone drilling which may lead to permanent death of bone tissues and nerves. During bone drilling the temperature of the bone tissues increases to higher values above 47 ⁰C that causes thermal osteonecrosis resulting into screw loosening and subsequent implant failures. An attempt has been made here to study the input drilling parameters and surgical drill bit geometry affecting bone health during bone drilling. A One Factor At a Time (OFAT) method is used to plan the experiments. Input drilling parameters studied include spindle speed and feed rate. The drill bit geometry parameter studied include point angle and helix angle. The output variables are drilling thrust force and bone temperature. The experiments were conducted on goat femur bone at room temperature 30 ⁰C. For measurement of thrust forces KISTLER cutting force dynamometer Type 9257BA was used. For continuous data acquisition of temperature NI LabVIEW software was used. Fixture was made on RPT machine for holding the bone specimen while performing drilling operation. Bone specimen were preserved in deep freezer (LABTOP make) under -40 ⁰C. In case of drilling parameters, it is observed that at constant feed rate when spindle speed increases, thrust force as well as temperature decreases and at constant spindle speed when feed rate increases thrust force as well as temperature increases. The effect of drill bit geometry shows that at constant helix angle when point angle increases thrust force as well as temperature increases and at constant point angle when helix angle increase thrust force as well as temperature decreases. Hence it is concluded that as the thrust force increases temperature increases. In case of drilling parameter, the lowest thrust force and temperature i.e. 35.55 N and 36.04 ⁰C respectively were recorded at spindle speed 2000 rpm and feed rate 0.04 mm/rev. In case of drill bit geometry parameter, the lowest thrust force and temperature i.e. 40.81 N and 34 ⁰C respectively were recorded at point angle 70⁰ and helix angle 25⁰ Hence to avoid thermal necrosis of bone it is recommended to use higher spindle speed, lower feed rate, low point angle and high helix angle. The hard nature of cortical bone contributes to a greater rise in temperature whereas a considerable drop in temperature is observed during cancellous bone drilling.

Keywords: bone drilling, helix angle, point angle, thrust force, temperature, thermal necrosis

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Authors: H. Pegram, R. Stevens, L. De Girolamo

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Aligned electrospun nanofibres act as effective neuronal and glial cell scaffolds that can be layered to contain multiple sheets harboring different cell populations. This allows personalised biofunctional prostheses to be manufactured with both acellular and cellularised layers for the treatment of spinal cord injury. Additionally, the manufacturing route may be configured to produce in-vitro 3D cell based model of spinal cord injury to aid drug development and enhance prosthesis performance. The goal of this investigation was to optimise the multi-layer scaffold design parameters for prosthesis manufacture, to enable the development of multi-layer patient specific implant therapies. The work has also focused on the fabricating aligned nanofibre scaffolds that promote in-vitro neuronal and glial cell population growth, cell-to-cell interaction and long-term survival following trauma to mimic an in-vivo spinal cord lesion. The approach has established reproducible lesions and has identified markers of trauma and regeneration marked by effective neuronal migration across the lesion with glial support. The investigation has advanced the development of an in-vitro model of traumatic spinal cord injury and has identified a route to manufacture prostheses which target the repair spinal cord injury. Evidence collated to investigate the multi-layer concept suggests that physical cues provided by nanofibres provide both a natural extra-cellular matrix (ECM) like environment and controls cell proliferation and migration. Specifically, aligned nanofibre layers act as a guidance system for migrating and elongating neurons. On a larger scale, material type in multi-layer systems also has an influence in inter-layer migration as cell types favour different material types. Results have shown that layering nanofibre membranes create a multi-level scaffold system which can enhance or prohibit cell migration between layers. It is hypothesised that modifying nanofibre layer material permits control over neuronal/glial cell migration. Using this concept, layering of neuronal and glial cells has become possible, in the context of tissue engineering and also modelling in-vitro induced lesions.

Keywords: electrospinning, layering, lesion, modeling, nanofibre

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Authors: Jason Hoellwarth, Atiya Oomatia, Anuj Chavan, Kevin Tetsworth, Munjed Al Muderis

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Introduction: Percutaneous EndoProsthetic Osseointegration for Limbs (PEPOL) facilitates improved quality of life (QOL) and objective mobility for most amputees discontent with their traditional socket prosthesis (TSP) experience. Some amputees desiring PEPOL have residual bone much shorter than the currently marketed press-fit implant lengths of 14-16 cm, potentially a risk for failure to integrate. We report on the techniques used, complications experienced, the management of those complications, and the overall mobility outcomes of seven patients who had femur distraction osteogenesis (DO) with a Freedom nail followed by PEPOL. Method: Retrospective evaluation of a prospectively maintained database identified nine patients (5 females) who had transfemoral DO in preparation for PEPOL with two years of follow-up after PEPOL. Six patients had traumatic causes of amputation, one had perinatal complications, one was performed to manage necrotizing fasciitis and one was performed as a result of osteosarcoma. Result: The average age at which DO commenced was 39.4±15.9 years, and seven patients had their amputation more than ten years prior (average 25.5±18.8 years). The residual femurs, on average, started at 102.2±39.7 mm and were lengthened 58.1±20.7 mm, 98±45% of the goal (99±161% of the original bone length). Five patients (56%) had a complication requiring additional surgery: four events of inadequate regeneration were managed with continued lengthening to the desired goal followed by autograft placement harvested from contralateral femur reaming; one patient had the cerclage wires break, which required operative replacement. All patients had osseointegration performed at 355±123 days after the initial lengthening nail surgery. One patient had K-level >2 before DO, at a mean of 3.4±0.6 (2.6-4.4) years following osseointegration. Six patients had K-level >2. The 6-Minute Walk Test remained unchanged (267±56 vs. 308 ± 117 meters). Patient self-rating of prosthesis function, problems, and amputee situation did not significantly change from before DO to after osseointegration. Six patients required additional surgery following osseointegration: six to remove fixation plates placed to maintain distraction osteogenesis length at osseointegration; two required irritation and debridement for infection. Conclusion: Extremely short residual femurs, which make TSP use troublesome, can be lengthened with externally controlled telescoping nails and successfully achieve osseointegration. However, it is imperative to counsel patients that additional surgery to address inadequate regeneration or to remove painful hardware used to maintain fixation may be necessary. This may improve the amputee’s expectations before beginning a potentially arduous process.

Keywords: osseointegration, limb lengthening, quality of life, amputation

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Authors: Neeraj Vij, Christian Leber, Kenneth Schmidt

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Introduction: Total knee arthroplasty is a common procedure. It is well known that the biomechanics of the knee do not fully return to their normal state. Motion analysis has been used to study the biomechanics of the knee after total knee arthroplasty. The purpose of this scoping review is to summarize the current use of gait analysis in total knee arthroplasty and to identify the preoperative motion analysis parameters for which a systematic review aimed at determining the reliability and validity may be warranted. Materials and Methods: This IRB-exempt scoping review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist strictly. Five search engines were searched for a total of 279 articles. Articles underwent a title and abstract screening process followed by full-text screening. Included articles were placed in the following sections: the role of gait analysis as a research tool for operative decisions, other research applications for motion analysis in total knee arthroplasty, gait analysis as a tool in predicting radiologic outcomes, gait analysis as a tool in predicting clinical outcomes. Results: Eleven articles studied gait analysis as a research tool in studying operative decisions. Motion analysis is currently used to study surgical approaches, surgical techniques, and implant choice. Five articles studied other research applications for motion analysis in total knee arthroplasty. Other research applications for motion analysis currently include studying the role of the unicompartmental knee arthroplasty and novel physical therapy protocols aimed at optimizing post-operative care. Two articles studied motion analysis as a tool for predicting radiographic outcomes. Preoperative gait analysis has identified parameters than can predict postoperative tibial component migration. 15 articles studied motion analysis in conjunction with clinical scores. Conclusions: There is a broad range of applications within the research domain of total knee arthroplasty. The potential application is likely larger. However, the current literature is limited by vague definitions of ‘gait analysis’ or ‘motion analysis’ and a limited number of articles with preoperative and postoperative functional and clinical measures. Knee adduction moment, knee adduction impulse, total knee range of motion, varus angle, cadence, stride length, and velocity have the potential for integration into composite clinical scores. A systematic review aimed at determining the validity, reliability, sensitivities, and specificities of these variables is warranted.

Keywords: motion analysis, joint replacement, patient-reported outcomes, knee surgery

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Authors: A. Mulry, C. Kealey, D. B. Brady

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Planktonic bacteria can form biofilms which are microbial aggregates embedded within a matrix of extracellular polymeric substances (EPS). They can be found attached to abiotic or biotic surfaces. Biofilms are responsible for oral diseases such as dental caries, gingivitis and the progression of periodontal disease. Biofilms can resist 500 to 1000 times the concentration of biocides and antibiotics used to kill planktonic bacteria. Biofilm development on oral surfaces involves four stages, initial attachment, early development, maturation and dispersal of planktonic cells. The Minimum Inhibitory Concentration (MIC) was determined using a range of saturated and unsaturated fatty acids using the resazurin assay, followed by serial dilution and spot plating on BHI agar plates to establish the Minimum Bactericidal Concentration (MBC). Log reduction of bacteria was also evaluated for each fatty acid. The Minimum Biofilm Inhibition Concentration (MBIC) was determined using crystal violet assay in 96 well plates on forming and pre-formed S. mutans biofilms using BHI supplemented with 1% sucrose. Saturated medium-chain fatty acids Octanoic (C8.0), Decanoic (C10.0) and Undecanoic acid (C11.0) do not display strong antibiofilm properties; however, Lauric (C12.0) and Myristic (C14.0) display moderate antibiofilm properties with 97.83% and 97.5% biofilm inhibition with 1000 µM respectively. Monounsaturated, Oleic acid (C18.1) and polyunsaturated large chain fatty acids, Linoleic acid (C18.2) display potent antibiofilm properties with biofilm inhibition of 99.73% at 125 µM and 100% at 65.5 µM, respectively. Long-chain polyunsaturated Omega-3 fatty acids α-Linoleic (C18.3), Eicosapentaenoic Acid (EPA) (C20.5), Docosahexaenoic Acid (DHA) (C22.6) have displayed strong antibiofilm efficacy from concentrations ranging from 31.25-250µg/ml. DHA is the most promising antibiofilm agent with an MBIC of 99.73% with 15.625µg/ml. This may be due to the presence of six double bonds and the structural orientation of the fatty acid. To conclude, fatty acids displaying the most antimicrobial activity appear to be medium or long-chain unsaturated fatty acids containing one or more double bonds. Most promising agents include Omega-3-fatty acids Linoleic, α-Linoleic, EPA and DHA, as well as Omega-9 fatty acid Oleic acid. These results indicate that fatty acids have the potential to be used as antimicrobials and antibiofilm agents against S. mutans. Future work involves further screening of the most potent fatty acids against a range of bacteria, including Gram-positive and Gram-negative oral pathogens. Future work will involve incorporating the most effective fatty acids onto dental implant devices to prevent biofilm formation.

Keywords: antibiofilm, biofilm, fatty acids, S. mutans

Procedia PDF Downloads 157

Authors: Allaire Eric, Hauet Pascal, Floresco Jean, Beley Sebastien, Sussman Helene, Virag Ronald

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Background: Caverno-venous leakage (CVL) is devastating, although barely known disease, the first cause of major physical impairment in men under 25, and responsible for 50% of resistances to phosphodiesterase 5-inhibitors (PDE5-I), affecting 30 to 40% of users in this medication class. In this condition, too early blood drainage from corpora cavernosa prevents penile rigidity and penetration during sexual intercourse. The role of conservative surgery in this disease remains controversial. Aim: Assess complications and results of combined open surgery and embolization for CVL. Method: Between June 2016 and September 2021, 133 consecutive patients underwent surgery in our institution for CVL, causing severe erectile dysfunction (ED) resistance to oral medical treatment. Procedures combined vein embolization and ligation with microsurgical techniques. We performed a pre-and post-operative clinical (Erection Harness Scale: EHS) hemodynamic evaluation by duplex sonography in all patients. Before surgery, the CVL network was visualized by computed tomography cavernography. Penile EMG was performed in case of diabetes or suspected other neurological conditions. All patients were optimized for hormonal status—data we prospectively recorded. Results: Clinical signs suggesting CVL were ED since age lower than 25, loss of erection when changing position, penile rigidity varying according to the position. Main complications were minor pulmonary embolism in 2 patients, one after airline travel, one with Factor V Leiden heterozygote mutation, one infection and three hematomas requiring reoperation, one decreased gland sensitivity lasting for more than one year. Mean pre-operative pharmacologic EHS was 2.37+/-0.64, mean pharmacologic post-operative EHS was 3.21+/-0.60, p<0.0001 (paired t-test). The mean EHS variation was 0.87+/-0.74. After surgery, 81.5% of patients had a pharmacologic EHS equal to or over 3, allowing for intercourse with penetration. Three patients (2.2%) experienced lower post-operative EHS. The main cause of failure was leakage from the deep dorsal aspect of the corpus cavernosa. In a 14 months follow-up, 83.2% of patients had a clinical EHS equal to or over 3, allowing for sexual intercourse with penetration, one-third of them without any medication. 5 patients had a penile implant after unsuccessful conservative surgery. Conclusion: Open surgery combined with embolization for CVL is an efficient approach to CVL causing severe erectile dysfunction.

Keywords: erectile dysfunction, cavernovenous leakage, surgery, embolization, treatment, result, complications, penile duplex sonography

Procedia PDF Downloads 149

Authors: Laura Canagueral-Pellice, Antonio Munar-Frau, Adaia Valls-Ontanon, Joao Carames, Federico Hernandez-Alfaro, Jordi Caballe-Serrano

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Objective: Guided bone regeneration (GBR) aims to replace the missing bone with a new structure to achieve long-term stability of rehabilitations. The aim of the present systematic review and meta-analysis is to determine the effect of barrier membranes on histological outcomes after GBR procedures. Moreover, the effect of the grafting material and tissue gain were analyzed. Materials & methods: Two independent reviewers performed an electronic search in Pubmed and Scopus, identifying all eligible publications up to March 2020. Only randomized controlled trials (RCTs) assessing a histological analysis of augmented areas were included. Results: A total of 6 publications were included for the present systematic review. A total of 110 biopsied sites were analysed; 10 corresponded to vertical bone augmentation procedures, whereas 100 analysed horizontal regeneration procedures. A mean tissue gain of 3 ± 1.48mm was obtained for horizontal defects. Histological assessment of new bone formation, residual particle and sub-epithelial connective tissue (SCT) was reported. The four main barrier membranes used were natural collagen membranes, e-PTFE, polylactic resorbable membranes and acellular dermal matrix membranes (AMDG). The analysis demonstrated that resorbable membranes result in higher values of new bone formation and lower values of residual particles and SCT. Xenograft resulted in lower new bone formation compared to allograft; however, no statistically significant differences were observed regarding residual particle and SCT. Overall, regeneration procedures adding autogenous bone, plasma derivate or growth factors achieved in general greater new bone formation and tissue gain. Conclusions: There is limited evidence favoring the effect of a certain type of barrier membrane in GBR. Data needs to be evaluated carefully; however, resorbable membranes are correlated with greater new bone formation values, especially when combined with allograft materials and/or the addition of autogenous bone, platelet reach plasma (PRP) or growth factors in the regeneration area. More studies assessing the histological outcomes of different GBR protocols and procedures testing different biomaterials are needed to maximize the clinical and histological outcomes in bone regeneration science.

Keywords: barrier membrane, graft material, guided bone regeneration, implant surgery, histology

Procedia PDF Downloads 152

Authors: Haiqiao Du, Qian Wang, Shuwei Wang, Jianan Li

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Purpose: The aim is to evaluate the effect of cochlear implantation (CI) in patients with unilateral hearing loss, with a view to providing data support for the selection of therapeutic interventions for patients with single-sided deafness (SSD)/asymmetric hearing loss (AHL) and the broadening of the indications for CI. Methods: The study subjects were patients with unilateral hearing loss who underwent cochlear implantation surgery in our hospital in August 2022 and were willing to cooperate with the test and were divided into 2 groups: SSD group and AHL group. The enrolled patients were followed up for hearing level, tinnitus changes, speech recognition ability, sound source localization ability, and quality of life at five-time points: preoperatively, and 1, 3, 6, and 12 months after postoperative start-up. Results: As of June 30, 2024, a total of nine patients completed follow-up, including four in the SSD group and five in the AHL group. The mean postoperative hearing aid thresholds on the CI side were 31.56 dB HL and 34.75 dB HL in the two groups, respectively. Of the four patients with preoperative tinnitus symptoms (three patients in the SSD group and one patient in the AHL group), all showed a degree of reduction in Tinnitus Handicap Inventory (THI) scores, except for one patient who showed no change. In both the SSD and AHL groups, the sound source localization results (expressed as RMS error values, with smaller values indicating better ability) were 66.87° and 77.41° preoperatively and 29.34° and 54.60° 12 months after postoperative start-up, respectively, which showed that the ability to localize the sound source improved significantly with longer implantation time. The level of speech recognition was assessed by 3 test methods: speech recognition rate of monosyllabic words in a quiet environment and speech recognition rate of different sound source directions at 0° and 90° (implantation side) in a noisy environment. The results of the 3 tests were 99.0%, 72.0%, and 36.0% in the preoperative SSD group and 96.0%, 83.6%, and 73.8% in the AHL group, respectively, whereas they fluctuated in the postoperative period 3 months after start-up, and stabilized at 12 months after start-up to 99.0%, 100.0%, and 100.0% in the SSD group and 99.5%, 96.0%, and 99.0%. Quality of life was subjectively evaluated by three tests: the Speech Spatial Quality of Sound Auditory Scale (SSQ-12), the Quality-of-Life Bilateral Listening Questionnaire (QLBHE), and the Nijmegen Cochlear Implantation Inventory (NCIQ). The results of the SSQ-12 (with a 10-point score out of 10) showed that the scores of preoperative and postoperative 12 months after start-up were 6.35 and 6.46 in the SSD group, while they were 5.61 and 9.83 in the AHL group. The QLBHE scores (100 points out of 100) were 61.0 and 76.0 in the SSD group and 53.4 and 63.7 in the AHL group for the preoperative versus the postoperative 12 months after start-up. Conclusion: Patients with unilateral hearing loss can benefit from cochlear implantation: CI implantation is effective in compensating for the hearing on the affected side and reduces the accompanying tinnitus symptoms; there is a significant improvement in sound source localization and speech recognition in the presence of noise; and the quality of life is improved.

Keywords: single-sided deafness, asymmetric hearing loss, cochlear implant, unilateral hearing loss

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Authors: Sundaresan Soundararajan, Chor Ngee Tan

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Introduction: Pyogenic spondylitis, otherwise treated conservatively with long term antibiotics, would require surgical debridement and reconstruction in about 10% to 20% of cases. The classical approach adopted many surgeons have always been anterior approach in ensuring thorough and complete debridement. This, however, comes with high rates of morbidity due to the nature of its access. Direct lateral retroperitoneal approach, which has been growing in usage in degenerative lumbar diseases, has the potential in treating pyogenic spondylitis with its ease of approach and relatively low risk of complications. Aims/Objectives: The objective of this study was to evaluate the effectiveness and clinical outcome of using lateral approach surgery in the surgical management of pyogenic spondylitis of the lumbar spine. Methods: Retrospective chart analysis was done on all patients who presented with pyogenic spondylitis (lumbar discitis/vertebral osteomyelitis) and had undergone direct lateral retroperitoneal lumbar vertebral debridement and posterior instrumentation between 2014 and 2016. Data on blood loss, surgical operating time, surgical complications, clinical outcomes and fusion rates were recorded. Results: A total of 6 patients (3 male and 3 female) underwent this procedure at a single institution by a single surgeon during the defined period. One patient presented with infected implant (PLIF) and vertebral osteomyelitis while the other five presented with single level spondylodiscitis. All patients underwent lumbar debridement, iliac strut grafting and posterior instrumentation (revision of screws for infected PLIF case). The mean operating time was 308.3 mins for all 6 cases. Mean blood loss was reported at 341cc (range from 200cc to 600cc). Presenting symptom of back pain resolved in all 6 cases while 2 cases that presented with lower limb weakness had improvement of neurological deficits. One patient had dislodged strut graft while performing posterior instrumentation and needed graft revision intraoperatively. Infective markers normalized for all patients subsequently. All subjects also showed radiological evidence of fusion on 6 months follow up. Conclusions: Lateral approach in treating pyogenic spondylitis is a viable option as it allows debridement and reconstruction without the risk that comes with other anterior approaches. It allows efficient debridement, short surgical time, moderate blood loss and low risk of vascular injuries. Clinical outcomes and fusion rates by this approach also support its use as practical MIS option surgery for such infection cases.

Keywords: lateral approach, minimally invasive, pyogenic spondylitis, XLIF

Procedia PDF Downloads 177

Authors: Ekaterina S. Marchenko, Gulsharat A. Baigonakova, Kirill M. Dubovikov, Igor A. Khlusov

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NiTi alloys combine biomechanical and biochemical properties. This makes them a perfect candidate for medical applications. However, there is a serious problem with these alloys, such as the release of Ni from the matrix. Ni ions are known to be toxic to living tissues and leach from the matrix into the surrounding implant tissues due to corrosion after prolonged use. To prevent the release of Ni ions, corrosive strong coatings are usually used. Titanium nitride-based coatings are perfect corrosion inhibitors and also have good bioactive properties. However, there is an opportunity to improve the biochemical compatibility of the surface by depositing another layer. This layer can consist of elements such as calcium and phosphorus. The Ca and P ions form different calcium phosphate phases, which are present in the mineral part of human bones. We therefore believe that these elements must promote osteogenesis and osteointegration. In view of the above, the aim of this study is to investigate the effect of crystallinity on the biocompatibility of a two-layer coating deposited on NiTi substrate by sputtering. The first step of the research, apart from the NiTi polishing, is the layer-by-layer deposition of Ti-Ni-Ti by magnetron sputtering and the subsequent synthesis of this composite in an N atmosphere at 900 °C. The total thickness of the corrosion resistant layer is 150 nm. Plasma assisted RF sputtering was then used to deposit a bioactive film on the titanium nitride layer. A Ca-P powder target was used to obtain such a film. We deposited three types of Ca-P layers with different crystallinity and compared them in terms of cytotoxicity. One group of samples had no Ca-P coating and was used as a control. We obtained different crystallinity by varying the sputtering parameters such as bias voltage, plasma source current and pressure. XRD analysis showed that all coatings are calcium phosphate, but the sample obtained at maximum bias and plasma source current and minimum pressure has the most intense peaks from the coating phase. SEM and EDS showed that all three coatings have a homogeneous and dense structure without cracks and consist of calcium, phosphorus and oxygen. Cytotoxic tests carried out on three types of samples with Ca-P coatings and a control group showed that the control sample and the sample with Ca-P coating obtained at maximum bias voltage and plasma source current and minimum pressure had the lowest number of dead cells on the surface, around 11 ± 4%. Two other types of samples with Ca-P coating have 40 ± 9% and 21 ± 7% dead cells on the surface. It can therefore be concluded that these two sputtering modes have a negative effect on the corrosion resistance of the whole samples. The third sputtering mode does not affect the corrosion resistance and has the same level of cytotoxicity as the control. It can be concluded that the most suitable sputtering mode is the third with maximum bias voltage and plasma source current and minimum pressure.

Keywords: calcium phosphate coating, cytotoxicity, NiTi alloy, two-layer coating

Procedia PDF Downloads 66

Authors: Kumaran Letchmanan, Shou-Cang Shen, Wai Kiong Ng

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Postoperative implant-associated infections in soft tissues and bones remain a serious complication in orthopaedic surgery, which leads to impaired healing, re-implantation, prolong hospital stay and increase cost. Drug-loaded implants with sustained release of antibiotics at the local site are current research interest to reduce the risk of post-operative infections and osteomyelitis, thus, minimize the need for follow-up care and increase patient comfort. However, the improved drug release of the drug-loaded bone cements is usually accompanied by a loss in mechanical strength, which is critical for weight-bearing bone cement. Recently, more attempts have been undertaken to develop techniques to enhance the antibiotic elution as well as preserve the mechanical properties of the bone cements. The present study investigates the potential influence of addition of mesoporous silica nanoparticles (MSN) on the in vitro drug release kinetics of gentamicin (GTMC), along with the mechanical properties of bone cements. Simplex P was formulated with MSN and loaded with GTMC by direct impregnation. Meanwhile, Simplex P with water soluble poragen (xylitol) and high loading of GTMC as well as commercial bone cement CMW Smartset GHV were used as controls. MSN-formulated bone cements are able to increase the drug release of GTMC by 3-fold with a cumulative release of more than 46% as compared with other control groups. Furthermore, a sustained release could be achieved for two months. The loaded nano-sized MSN with uniform pore channels significantly build up an effective nano-network path in the bone cement facilitates the diffusion and extended release of GTMC. Compared with formulations using xylitol and high GTMC loading, incorporation of MSN shows no detrimental effect on biomechanical properties of the bone cements as no significant changes in the mechanical properties as compared with original bone cement. After drug release for two months, the bending modulus of MSN-formulated bone cements is 4.49 ± 0.75 GPa and the compression strength is 92.7 ± 2.1 MPa (similar to the compression strength of Simplex-P: 93.0 ± 1.2 MPa). The unaffected mechanical properties of MSN-formulated bone cements was due to the unchanged microstructures of bone cement, whereby more than 98% of MSN remains in the matrix and supports the bone cement structures. In contrast, the large portions of extra voids can be observed for the formulations using xylitol and high drug loading after the drug release study, thus caused compressive strength below the ASTM F541 and ISO 5833 minimum of 70 MPa. These results demonstrate the potential applicability of MSN-functionalized poly(methyl methacrylate)-based bone cement as a highly efficient, sustained and local drug delivery system with good mechanical properties.

Keywords: antibiotics, biomechanical properties, bone cement, sustained release

Procedia PDF Downloads 257

Authors: Z. Karahaliloğlu, E. Yalçın, M. Demirbilek, E.B. Denkbaş

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Critical-sized bone defects caused by trauma, bone diseases, prosthetic implant revision or tumor excision cannot be repaired by physiological regenerative processes. Current orthopedic applications for critical-sized bone defects are to use autologous bone grafts, bone allografts, or synthetic graft materials. However, these strategies are unable to solve completely the problem, and motivate the development of novel effective biological scaffolds for tissue engineering applications and regenerative medicine applications. In particular, scaffolds combined with a variety of bio-agents as fundamental tools emerge to provide the regeneration of damaged bone tissues due to their ability to promote cell growth and function. In this study, a magnetic silk fibroin (SF) hydrogel scaffold was prepared by electrogelation process of the concentrated Bombxy mori silk fibroin (8 %wt) aqueous solution. For enhancement of osteoblast-like cells (SaOS-2) growth and adhesion, basal fibroblast growth factor (bFGF) were conjugated physically to the HSA-coated magnetic nanoparticles (Fe3O4) and magnetic SF e-gel scaffolds were prepared by incorporation of Fe3O4, HSA (human serum albumin)=Fe3O4 and HSA=Fe3O4-bFGF nanoparticles. HSA=Fe3O4, HSA=Fe3O4-bFGF loaded and bare SF e-gels scaffolds were characterized using scanning electron microscopy (SEM.) For cell studies, human osteoblast-like cell line (SaOS-2) was used and an MTT assay was used to assess the cytotoxicity of magnetic silk fibroin e-gel scaffolds and cell density on these surfaces. For the evaluation osteogenic activation, ALP (alkaline phosphatase), the amount of mineralized calcium, total protein and collagen were studied. Fe3O4 nanoparticles were successfully synthesized and bFGF was conjugated to HSA=Fe3O4 nanoparticles with %97.5 of binding yield which has a particle size of 71.52±2.3 nm. Electron microscopy images of the prepared HSA and bFGF incorporated SF e-gel scaffolds showed a 3D porous morphology. In terms of water uptake results, bFGF conjugated HSA=Fe3O4 nanoparticles has the best water absorbability behavior among all groups. In the in-vitro cell culture studies realized using SaOS-2 cell line, the coating of Fe3O4 nanoparticles surface with a protein enhance the cell viability and HSA coating and bFGF conjugation, the both have an inductive effect in the cell proliferation. One of the markers of bone formation and osteoblast differentiation, according to the ALP activity and total protein results, HSA=Fe3O4-bFGF loaded SF e-gels had significantly enhanced ALP activity. Osteoblast cultured HSA=Fe3O4-bFGF loaded SF e-gels deposited more calcium compared with SF e-gel. The proposed magnetic scaffolds seem to be promising for bone tissue regeneration and used in future work for various applications.

Keywords: basic fibroblast growth factor (bFGF), e-gel, iron oxide nanoparticles, silk fibroin

Procedia PDF Downloads 288

Authors: Sri Sai Ramya Bojedla, Falguni Pati

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Nature provides the best of solutions to humans. One such incredible gift to regenerative medicine is silk. The literature has publicized a long appreciation for silk owing to its incredible physical and biological assets. Its bioactive nature, unique mechanical strength, and processing flexibility make us curious to explore further to apply it in the clinics for the welfare of mankind. In this study, Antheraea mylitta and Bombyx mori silk fibroin microfibers are developed by two economical and straightforward steps via degumming and hydrolysis for the first time, and a bioactive composite is manufactured by mixing silk fibroin microfibers at various concentrations with polycaprolactone (PCL), a biocompatible, aliphatic semi-crystalline synthetic polymer. Reconstructive surgery in any part of the body except for the maxillofacial region deals with replacing its function. But answering both the aesthetics and function is of utmost importance when it comes to facial reconstruction as it plays a critical role in the psychological and social well-being of the patient. The main concern in developing adequate bone graft substitutes or a scaffold is the noteworthy variation in each patient's bone anatomy. Additionally, the anatomical shape and size will vary based on the type of defect. The advent of additive manufacturing (AM) or 3D printing techniques to bone tissue engineering has facilitated overcoming many of the restraints of conventional fabrication techniques. The acquired patient's CT data is converted into a stereolithographic (STL)-file which is further utilized by the 3D printer to create a 3D scaffold structure in an interconnected layer-by-layer fashion. This study aims to address the limitations of currently available materials and fabrication technologies and develop a customized biomaterial implant via 3D printing technology to reconstruct complex form, function, and aesthetics of the facial anatomy. These composite scaffolds underwent structural and mechanical characterization. Atomic force microscopic (AFM) and field emission scanning electron microscopic (FESEM) images showed the uniform dispersion of the silk fibroin microfibers in the PCL matrix. With the addition of silk, there is improvement in the compressive strength of the hybrid scaffolds. The scaffolds with Antheraea mylitta silk revealed higher compressive modulus than that of Bombyx mori silk. The above results of PCL-silk scaffolds strongly recommend their utilization in bone regenerative applications. Successful completion of this research will provide a great weapon in the maxillofacial reconstructive armamentarium.

Keywords: compressive modulus, 3d printing, maxillofacial reconstruction, natural fiber reinforced composites, silk fibroin microfibers

Procedia PDF Downloads 197

Authors: Eva Filová, Jana Daňková, Věra Sovková, Matej Daniel

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Titanium alloys are biocompatible metals that are widely used in clinical practice as load bearing implants. The chemical modification may influence cell adhesion, proliferation, and differentiation as well as stiffness of the material. The aim of the study was to evaluate the adhesion, growth and differentiation of pig mesenchymal stem cells on the novel beta titanium alloy Ti36Nb6Ta compared to standard medical titanium alloy Ti6Al4V. Discs of Ti36Nb6Ta and Ti6Al4V alloy were sterilized by ethanol, put in 48-well plates, and seeded by pig mesenchymal stem cells at the density of 60×103/cm2 and cultured in Minimum essential medium (Sigma) supplemented with 10% fetal bovine serum and penicillin/streptomycin. Cell viability was evaluated using MTS assay (CellTiter 96® AQueous One Solution Cell Proliferation Assay;Promega), cell proliferation using Quant-iT™ ds DNA Assay Kit (Life Technologies). Cells were stained immunohistochemically using monoclonal antibody beta-actin, and secondary antibody conjugated with AlexaFluor®488 and subsequently the spread area of cells was measured. Cell differentiation was evaluated by alkaline phosphatase assay using p-nitrophenyl phosphate (pNPP) as a substrate; the reaction was stopped by NaOH, and the absorbance was measured at 405 nm. Osteocalcin, specific bone marker was stained immunohistochemically and subsequently visualized using confocal microscopy; the fluorescence intensity was analyzed and quantified. Moreover, gene expression of osteogenic markers osteocalcin and type I collagen was evaluated by real-time reverse transcription-PCR (qRT-PCR). For statistical evaluation, One-way ANOVA followed by Student-Newman-Keuls Method was used. For qRT-PCR, the nonparametric Kruskal-Wallis Test and Dunn's Multiple Comparison Test were used. The absorbance in MTS assay was significantly higher on titanium alloy Ti6Al4V compared to beta titanium alloy Ti36Nb6Ta on days 7 and 14. Mesenchymal stem cells were well spread on both alloys, but no difference in spread area was found. No differences in alkaline phosphatase assay, fluorescence intensity of osteocalcin as well as the expression of type I collagen, and osteocalcin genes were observed. Higher expression of type I collagen compared to osteocalcin was observed for cells on both alloys. Both beta titanium alloy Ti36Nb6Ta and titanium alloy Ti6Al4V Ti36Nb6Ta supported mesenchymal stem cellsˈ adhesion, proliferation and osteogenic differentiation. Novel beta titanium alloys Ti36Nb6Ta is a promising material for bone implantation. The project was supported by the Czech Science Foundation: grant No. 16-14758S, the Grant Agency of the Charles University, grant No. 1246314 and by the Ministry of Education, Youth and Sports NPU I: LO1309.

Keywords: beta titanium, cell growth, mesenchymal stem cells, titanium alloy, implant

Procedia PDF Downloads 316

Authors: Shiva Naidoo, Kristena Yossef, Grimm Jimm, Mirza Wasique, Eric Kemmerer, Joshua Obuch, Anand Mahadevan

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Background: Fiducial markers effectively enhance tumor target visibility prior to Stereotactic Body Radiation Therapy or Proton therapy. To streamline clinical practice, fiducial placement guidelines from a robotic radiosurgery vendor were examined with the goals of optimizing and standardizing feasible geometries for each treatment indication. Clinical examples of prostate, renal, and pancreatic cases are presented. Methods: Vendor guidelines (Accuray, Sunnyvale, Ca) suggest implantation of 4–6 fiducials at least 20 mm apart, with at least a 15-degree angular difference between fiducials, within 50 mm or less from the target centroid, to ensure that any potential fiducial motion (e.g., from respiration or abdominal/pelvic pressures) will mimic target motion. Also recommended is that all fiducials can be seen in 45-degree oblique views with no overlap to coincide with the robotic radiosurgery imaging planes. For the prostate, a standardized geometry that meets all these objectives is a 2 cm-by-2 cm square in the coronal plane. The transperineal implant of two pairs of preloaded tandem fiducials makes the 2 cm-by-2 cm square geometry clinically feasible. This technique may be applied for renal cancer, except repositioned in a sagittal plane, with the retroperitoneal placement of the fiducials into the tumor. Pancreatic fiducial placement via endoscopic ultrasound (EUS) is technically more challenging, as fiducial placement is operator-dependent, and lesion access may be limited by adjacent vasculature, tumor location, or restricted mobility of the EUS probe in the duodenum. Fluoroscopically assisted fiducial placement during EUS can help ensure fiducial markers are deployed with optimal geometry and visualization. Results: Among the first 22 fiducial cases on a newly installed robotic radiosurgery system, live x-ray images for all nine prostatic cases had excellent fiducial visualization at the treatment console. Renal and pancreatic fiducials were not as clearly visible due to difficult target access and smaller caliber insertion needle/fiducial usage. The geometry of the first prostate case was used to ensure accurate geometric marker placement for the remaining 8 cases. Initially, some of the renal and pancreatic fiducials were closer than the 20 mm recommendation, and interactive feedback with the proceduralists led to subsequent fiducials being too far to the edge of the tumor. Further feedback and discussion of all cases are being used to help guide standardized geometries and achieve ideal fiducial placement. Conclusion: The ideal tradeoffs of fiducial visibility versus the thinnest possible gauge needle to avoid complications needs to be systematically optimized among all patients, particularly in regards to body habitus. Multidisciplinary collaboration among proceduralists and radiation oncologists can lead to improved outcomes.

Keywords: fiducial, prostate cancer, renal cancer, pancreatic cancer, radiotherapy

Procedia PDF Downloads 93

Authors: J. Waita, S. Wamuhu, J. Makoyo, M. Rachel, T. Ngangari, W. Christine, M. Zipporah

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Contraceptive use is one of the key global strategies to alleviate maternal mortality. Global efforts through advocating for contraceptive uptake and service provision has led improved contraceptive prevalence. In Kenya maternal mortality rate has remained a challenged despites efforts by government and non-governmental organizations. Objective: To describe the uptake of contraceptives among women in Tunza Clinics, Kenya. Design and Methods: Ps Kenya through health care marketing fund is implementing a family planning program among its 350 Tunza fractional franchise facilities. Through private partnership, private owned facilities in low socio-economic areas are recruited and trained on contraceptive technology update. The providers are supported through facilitative supervision through a mobile based application Health Network Quality Improvement System (HNQIS) and interpersonal communication through 150 community based volunteers. The data analyzed in this paper was collected between January to July 2017 to show the uptake of modern Contraceptives among women in the Tunza franchise, method mix, age and distribution among the age bracket. Further analysis compares two different service delivery strategies; outreach and walk ins. Supportive supervision HNQIS scores was analyzed. Results: During the time period, a total of 132121 family planning clients were attended in 350 facilities. The average age of clients was 29.6 years. The average number of clients attended in the facilities per month was 18874. 73.7 %( n=132121) of the clients attended in the Tunza facilities were aged above 25 years while 22.1% 20-24 years and 4.2% 15-19 years. On contraceptive method mix, intra uterine device insertions clients contributed to 7.5%, implant insertions 15.3%, pills 11.2%, injections 62.7% while condoms and emergency pills had 2.7% and 0.6% respectively. Analysis of service delivery strategy indicated more than 79% of the clients were walk ins while 21% were attended to during outreaches. Uptake of long term contraceptive methods during outreaches was 73% of the clients while short term modern methods were 27%. Health Network Quality Improvement system assessment scores indicated 51% of the facilities scored over 90%, 25% scoring 80-89% while 21% scored below 80%. Conclusion: Preference for short term methods by women is possibly associated to cost as they are cheaper and easy to administer. When the cost of intra uterine device Implants is meant affordable during outreaches, the uptake is observed to increase. Making intra uterine device and implants affordable to women is a key strategy in increasing contraceptive prevalence hence averting maternal mortality.

Keywords: contraceptives, contraceptive uptake, low socio economic, supportive supervision

Procedia PDF Downloads 168

Authors: Kanchan Maji, Debasmita Pani, Sudip Dasgupta

Abstract:

Calcium phosphate cement (CPC) due to its high bioactivity and optimum bioresorbability shows excellent bone regeneration capability. Despite it has limited applications as bone implant due to its macro-porous microstructure causing its poor mechanical strength. The reinforcement of apatitic CPCs with biocompatible fibre glass phase is an attractive area of research to improve its mechanical strength. Here we study the setting behaviour of Si-doped and un-doped alpha tri-calcium phosphate (α-TCP) based CPC and its reinforcement with the addition of E-glass fibre. Alpha tri-calcium phosphate powders were prepared by solid state sintering of CaCO3, CaHPO4 and tetra ethyl ortho silicate (TEOS) was used as silicon source to synthesise Si doped α-TCP powders. Alpha tri-calcium phosphate based CPC hydrolyzes to form hydroxyapatite (HA) crystals having excellent osteoconductivity and bone-replacement capability thus self-hardens through the entanglement of HA crystals. Setting time, phase composition, hydrolysis conversion rate, microstructure, and diametral tensile strength (DTS) of un-doped CPC and Si-doped CPC were studied and compared. Both initial and final setting time of the developed cement was delayed because of Si addition. Crystalline phases of HA (JCPDS 9-432), α-TCP (JCPDS 29-359) and β-TCP (JCPDS 9-169) were detected in the X-ray diffraction (XRD) pattern after immersion of CPC in simulated body fluid (SBF) for 0 hours to 10 days. The intensities of the α-TCP peaks of (201) and (161) at 2θ of 22.2°and 24.1° decreased when the time of immersion of CPC in SBF increased from 0 hours to 10 days, due to its transformation into HA. As Si incorporation in the crystal lattice stabilised the TCP phase, Si doped CPC showed a little slower rate of conversion into HA phase as compared to un-doped CPC. The SEM image of the microstructure of hardened CPC showed lower grain size of HA in un-doped CPC because of premature setting and faster hydrolysis of un-doped CPC in SBF as compared that in Si-doped CPC. Premature setting caused generation of micro and macro porosity in un-doped CPC structure which resulted in its lower mechanical strength as compared to that in Si-doped CPC. This lower porosity and greater compactness in the microstructure attributes to greater DTS values observed in Si-doped CPC. E-glass fibres of the average diameter of 12 μm were cut into approximately 1 mm in length and immersed in SBF to deposit carbonated apatite on its surface. This was performed to promote HA crystal growth and entanglement along the fibre surface to promote stronger interface between dispersed E-glass fibre and CPC matrix. It was found that addition of 10 wt% of E-glass fibre into Si-doped α-TCP increased the average DTS of CPC from 8 MPa to 15 MPa as the fibres could resist the propagation of crack by deflecting the crack tip. Our study shows that biocompatible E-glass fibre in optimum proportion in CPC matrix can enhance the mechanical strength of CPC without affecting its bioactivity.

Keywords: Calcium phosphate cement, biocompatibility, e-glass fibre, diametral tensile strength

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Authors: Nir Nissim, Erez Shalom, Tomer Lancewiki, Yuval Elovici, Yuval Shahar

Abstract:

Background: A Medical Device (MD) is an instrument, machine, implant, or similar device that includes a component intended for the purpose of the diagnosis, cure, treatment, or prevention of disease in humans or animals. Medical devices play increasingly important roles in health services eco-systems, including: (1) Patient Diagnostics and Monitoring; Medical Treatment and Surgery; and Patient Life Support Devices and Stabilizers. MDs are part of the medical device eco-system and are connected to the network, sending vital information to the internal medical information systems of medical centers that manage this data. Wireless components (e.g. Wi-Fi) are often embedded within medical devices, enabling doctors and technicians to control and configure them remotely. All these functionalities, roles, and uses of MDs make them attractive targets of cyber-attacks launched for many malicious goals; this trend is likely to significantly increase over the next several years, with increased awareness regarding MD vulnerabilities, the enhancement of potential attackers’ skills, and expanded use of medical devices. Significance: We propose to develop and implement Cyber-Med, a unique collaborative project of Ben-Gurion University of the Negev and the Clalit Health Services Health Maintenance Organization. Cyber-Med focuses on the development of a comprehensive detection framework that relies on a critical attack repository that we aim to create. Cyber-Med will allow researchers and companies to better understand the vulnerabilities and attacks associated with medical devices as well as providing a comprehensive platform for developing detection solutions. Methodology: The Cyber-Med detection framework will consist of two independent, but complementary detection approaches: one for known attacks, and the other for unknown attacks. These modules incorporate novel ideas and algorithms inspired by our team's domains of expertise, including cyber security, biomedical informatics, and advanced machine learning, and temporal data mining techniques. The establishment and maintenance of Cyber-Med’s up-to-date attack repository will strengthen the capabilities of Cyber-Med’s detection framework. Major Findings: Based on our initial survey, we have already found more than 15 types of vulnerabilities and possible attacks aimed at MDs and their eco-system. Many of these attacks target individual patients who use devices such pacemakers and insulin pumps. In addition, such attacks are also aimed at MDs that are widely used by medical centers such as MRIs, CTs, and dialysis engines; the information systems that store patient information; protocols such as DICOM; standards such as HL7; and medical information systems such as PACS. However, current detection tools, techniques, and solutions generally fail to detect both the known and unknown attacks launched against MDs. Very little research has been conducted in order to protect these devices from cyber-attacks, since most of the development and engineering efforts are aimed at the devices’ core medical functionality, the contribution to patients’ healthcare, and the business aspects associated with the medical device.

Keywords: medical device, cyber security, attack, detection, machine learning

Procedia PDF Downloads 356

Authors: Zhuang Yiwen

Abstract:

The paper examines the challenges facing the Singapore healthcare system related to the tracking and traceability of medical devices. One of the major challenges identified is the lack of a standard coding system for medical devices, which makes it difficult to track them effectively. The paper suggests the use of the Unique Device Identifier (UDI) as a single standard for medical devices to improve tracking and reduce errors. The paper also explores the use of barcoding and image recognition to identify and document medical devices in nursing practices. In nursing practices, the use of barcodes for identifying medical devices is common. However, the information contained in these barcodes is often inconsistent, making it challenging to identify which segment contains the model identifier. Moreover, the use of barcodes may be improved with the use of UDI, but many subsidized accessories may still lack barcodes. The paper suggests that the readiness for UDI and barcode standardization requires standardized information, fields, and logic in electronic medical record (EMR), operating theatre (OT), and billing systems, as well as barcode scanners that can read various formats and selectively parse barcode segments. Nursing workflow and data flow also need to be taken into account. The paper also explores the use of image recognition, specifically the Tesseract OCR engine, to identify and document implants in public hospitals due to limitations in barcode scanning. The study found that the solution requires an implant information database and checking output against the database. The solution also requires customization of the algorithm, cropping out objects affecting text recognition, and applying adjustments. The solution requires additional resources and costs for a mobile/hardware device, which may pose space constraints and require maintenance of sterile criteria. The integration with EMR is also necessary, and the solution require changes in the user's workflow. The paper suggests that the long-term use of Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) as a supporting terminology to improve clinical documentation and data exchange in healthcare. SNOMED CT provides a standardized way of documenting and sharing clinical information with respect to procedure, patient and device documentation, which can facilitate interoperability and data exchange. In conclusion, the paper highlights the challenges facing the Singapore healthcare system related to the tracking and traceability of medical devices. The paper suggests the use of UDI and barcode standardization to improve tracking and reduce errors. It also explores the use of image recognition to identify and document medical devices in nursing practices. The paper emphasizes the importance of standardized information, fields, and logic in EMR, OT, and billing systems, as well as barcode scanners that can read various formats and selectively parse barcode segments. These recommendations could help the Singapore healthcare system to improve tracking and traceability of medical devices and ultimately enhance patient safety.

Keywords: medical device tracking, unique device identifier, barcoding and image recognition, systematized nomenclature of medicine clinical terms

Procedia PDF Downloads 76

Authors: Isabela S. Gonçalves, Vitor G. P. Lima, Tiago M. B. Campos, Marcos Jacobovitz, Luana M. R. Vasconcellos, Ivone R. Oliveira

Abstract:

Periodontitis is an infectious disease of multifactorial origin, which originates from a periodontogenic bacterial biofilm that colonizes the surfaces of the teeth, resulting in an inflammatory reaction to microbial aggression. In the absence of adequate treatment, it can lead to the gradual destruction of the periodontal ligaments, cementum and alveolar bone. In guided tissue/bone regeneration therapy (GTR/GBR), a barrier membrane is placed between the fibrous tissues and the bone defect to prevent unwanted incursions of fibrous tissues into the bone defect, thus allowing the regeneration of quality bone. Currently, there are a significant number of biodegradable barrier membranes available on the market. However, a very common problem is that the membranes are not bioactive/osteogenic, that is, they are incapable of inducing a favorable osteogenic response and integration with the host tissue, resulting in many cases in displacement/expulsion of the membrane, requiring a new surgical procedure and replacement of the implant. Aiming to improve the bioactive and osteogenic properties of the membrane, this work evaluated the production of membranes that integrate the biocompatibility of the hydrophilic synthetic polymer (polyvinyl alcohol - PVA) with the osteogenic effects of chlorinated bioactive glasses (BG58S-Cl), using the electrospinning equipment (AeroSpinner L1.0 from Areka) which allows the execution of spinning by high voltage and/or blowing in solution and with a high production rate, enabling development on an industrial scale. In the formulation of bioactive glasses, the replacement of nitrates by chlorinated molecules has shown to be a promising alternative, since the chloride ion is naturally present in the body and, with its presence in the bioactive glass, the biocompatibility of the material increases. Thus, in this work, chlorinated bioactive glasses were synthesized by the sol-gel route using the compounds tetraethyl orthosilicate (TEOS), calcium chloride dihydrate and monobasic ammonium phosphate with pH adjustments with 37% HCl (1.5 or 2.5) and different calcination temperatures (500, 600 and 700 °C) were evaluated. The BG-58S-Cl powders obtained were characterized by pH, conductivity and zeta potential x time curves and by SEM/FEG, FTIR-ATR and Raman tests. The material produced under the selected conditions was evaluated in relation to the milling procedure, obtaining particles suitable for incorporation into PVA polymer solutions to be electrospun (D50 = 22 µm). Membranes were produced and evaluated regarding the influence of the crosslinking agent content as well as the crosslinking treatment temperature (3, 5 and 10 wt% citric acid) and (130 or 175 oC) and were characterized by SEM/FEG, FTIR, TG and DSC. From the optimization of the crosslinking conditions, membranes were prepared by adding BG58S-Cl powder (5 and 10 wt%) to the PVA solutions and were characterized by SEM-FEG, DSC, bioactivity in SBF and behavior in cell culture (cell viability, total protein content, alkaline phosphatase, mineralization nodules). The micrographs showed homogeneity of the distribution of BG58S-Cl particles throughout the sample, favoring cell differentiation.

Keywords: barrier membranes, chlorinated bioactive glasses, polyvinyl alcohol, tissue regeneration.

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