Background: The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods: The experimentation was carried out according to the standards of ASTM-F-1264 and ISO-10993-5 for mechanical and biological tests respectively, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used.Results: With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank's solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions: These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.
Background The bio-fabrication of a porous scaffold from a selection procedure of elements taking into account the biological behavior, using Magnesium (Mg) alloyed with Calcium (Ca) and Zinc (Zn), it could work as a treatment for specific pathologies in trauma and oncology, on the one hand, in osteosynthesis, contributing to osseointegration and contributing to infection control through the release of drugs, additionally, another possible attribute of this alloy would be to be used as a complementary treatment for osteosarcoma, this is due to the basification produced by oxidative degradation. (Attack on cancer cells)(1)(2)(3)(4).Methods The evaluation of cell viability of an alloy of Mg − 25 wt% Ca + 5 wt% Zn will strengthen current perspectives on the use of Mg in the clinical evaluation of various treatments in trauma and oncology. Considerations on the preparation of an alloy of Mg − 25 wt% Ca + 5 wt% Zn and its morphological characterization, will help to understand the applicability for the development of new surgical techniques and lead to a deeper investigation in the conception of alternative treatments. However, it is very important to bear in mind the mechanical effect of elements such as Ca and Zn, on the degradation of the alloy matrix, the best alternative to predict the biological - mechanical potential starts with the selection of the essential - nutritional elements (5)(6)(7) and its mechanical evaluation by micro-indentation due to the fragility of the matrix (8)(9).Results Therefore, the morphological evaluation of the specimens of Mg − 25 wt% Ca + 5 wt% Zn will show the crystallinity of the alloy; these results together generate a contribution regarding the design of biomedical alloys for use in treatments for various medical specialties.Conclusions The results indicated that cell viability is not affected, and there are no morphological changes in the cells.
Background: The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods: Standardized procedures according to ASTM F-1264 and ISO-10993-5 were used, respecting detailed methodological controls to ensure accuracy and reproducibility of the results, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. Results: As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used. With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank's solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions: These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.Trial registration: N/A
Temporary antibiotic-loaded cement spacers are widely used for treating chronic periprosthetic hip infections. The aim of this study is to evaluate the short-term tribological performance of ultra-high-molecular-weight polyethylene (UHMWPE) and (60Co) gamma-irradiated cross-linked UHMWPE (XLPE) self-mated systems as frictional pairs for temporary total hip spacers. A three-axial hip joint simulator, FIME II, was used to test the UHMWPE and XLPE self-mated systems under variable load profiles. A fetal bovine serum solution was used as a lubricant. After simulation tests, wear measurements of damaged coupled surfaces were made with a coordinate measuring machine. Finally, surfaces were characterized with scanning electron microscopy, Raman spectroscopy, Fourier transform infrared spectroscopy, and nanoindentation tests. The mass loss test results for UHMWPE were 11.91 ± 3.43 mg for the cups and 4.57 ± 0.92 mg for the heads. Whereas, the results for XLPE showed a significant reduction, with mean mass loss values of 6.59 ± 0.14 mg for the cups and 2.82 ± 0.59 mg for the heads, suggesting the viability of the self-mated XLPE contact pair for a temporary total hip spacer.
Background The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods Standardized procedures according to ASTM F-1264 and ISO-10993-5 were used, respecting detailed methodological controls to ensure accuracy and reproducibility of the results, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. Results As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used. With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank’s solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.
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