A lean magnesium–zinc–calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model

Holweg, Patrick; Berger, Leopold; Cihova, Martina; Donohue, Nicholas; Clement, Bernhard; Schwarze, Uwe Yacine; Sommer, Nicole G.; Hohenberger, Gloria; Beucken, Jeroen J.J.P. van den; Seibert, F. J.; Leithner, Andreas; Löffler, Jörg F.; Weinberg, Annelie‐Martina

doi:10.1016/j.actbio.2020.06.013

Cited by 54 publications

(65 citation statements)

References 51 publications

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“…The detailed pre-clinical studies of these alloys were summarized in Table 1. [52] pin Rat femoral bones 7 days 0.15 ± 0.03 mm/y 26 Mg enriched (>99 wt.%) [53] pin Rat femoral bones 4, 24, 52 weeks 16 ± 5 µm/y Pure Mg high pressure (99.98 Mg in wt.%) [54] disk Rat femoral bones 24 weeks 0.41 ± 0.02 mm/y WE43 (>92.0 Mg in wt.%) [55] plates and screw Dogs-LeFort I osteotomy 4, 12, and 24 weeks NA 1 WE43 (>92.0 Mg in wt.%) [56] screw Rabbit tibiae 4, 8, 12 and 16 weeks NA 1 WE43 (>92.0 Mg in wt.%) [57] pin Rat tibiae 52 weeks NA 1 WE43/WE43T5 (>92.0 Mg in wt.%) [58] screw Sheep mandibule 6 and 24 weeks NA 1 MgYREZr (>92.0 Mg in wt.%) [59] screw Rabbit femoral bones 1, 12, and 52 weeks NA 1 JDBM (>95.0 Mg in wt.%) [60] screw Rabbit mandible bones 1, 4, and 7 months 0.161 ± 0.025 mm/y (1 month), 00.218 ± 0.030 mm/y (7 months) NZK (>96.0 Mg in wt.%) [61] rod Rabbit femoral bones 28 and 56 days 0.66 mm/y (28 days) and 0.48 mm/y (56 days) Mg-Zn (94.0 Mg in wt.%) [62] rod Rabbit femoral bones 14 weeks 2.32 mm/y ZX00 (>99.0 Mg in wt.%) [63] pin Rat femoral bones and sheep tibiae 6, 12 and 24weeks 0.08 mm/y (rat) and 0.045 mm/y (sheep) ZX00 (>99.0 Mg in wt.%) [64] screw Sheep tibiae 3, 6 and 12 weeks NA 1…”

Section: Mg and Its Alloysmentioning

confidence: 99%

Bioresorbable Magnesium-Based Alloys as Novel Biomaterials in Oral Bone Regeneration: General Review and Clinical Perspectives

Herber

Okutan

Antonoglou

et al. 2021

JCM

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Bone preservation and primary regeneration is a daily challenge in the field of dental medicine. In recent years, bioresorbable metals based on magnesium (Mg) have been widely investigated due to their bone-like modulus of elasticity, their high biocompatibility, antimicrobial, and osteoconductive properties. Synthetic Mg-based biomaterials are promising candidates for bone regeneration in comparison with other currently available pure synthetic materials. Different alloys based on Mg were developed to fit clinical requirements. In parallel, advances in additive manufacturing offer the possibility to fabricate experimentally bioresorbable metallic porous scaffolds. This review describes the promising clinical results of resorbable Mg-based biomaterials for bone repair in osteosynthetic application and discusses the perspectives of use in oral bone regeneration.

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Section: Mg and Its Alloysmentioning

confidence: 99%

Bioresorbable Magnesium-Based Alloys as Novel Biomaterials in Oral Bone Regeneration: General Review and Clinical Perspectives

Herber

Okutan

Antonoglou

et al. 2021

JCM

Self Cite

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“…After approximately 16 months, the WE43 will be almost completely excreted by the biological mechanisms of the human body. (5) This work establishes that the orientation of the grain must be horizontal to the load, which allows optimal increasing of the resistance, as shown by the FEM simulation representing the fracture behavior of the alloy. (6) L-929 murine fibroblasts experienced a cytotoxic outcome in a dose-response fashion when exposed for 24 h or 48 h to incremental concentrations of original extracts of WE43.…”

Section: Resultsmentioning

confidence: 73%

“…Today, the use of new biomaterials in the manufacturing of medical devices (MDs) in the world is of great relevance, as reducing the environmental impact of extracting and refining currently popular elements such as titanium (Ti) is an important goal (1). Currently, the potential of magnesium (Mg) as a base material for alloying with essential and nutritional elements such as Ca, Zn, and REEs is being widely investigated (2)(3)(4)(5)(6). The advantages and effects of its use have already been evaluated in vivo by different programs and organizations throughout the world (7)(8)(9)(10)(11).…”

Section: Introductionmentioning

confidence: 99%

Effect of Sterilization on 3-point Dynamic Response to in Vitro Bending of an Mg Implant

Becerra

Rodríguez

Arroyo

et al. 2020

Preprint

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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.

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“…(3) The choice of coating for any material is very important depending on medical application; the coating used for Mg alloys will determine the time that the alloy will provide mechanical resistance to a fracture. (4) A WE43 implant can withstand a test of 5x10 5 cycles. This is the same standard of traditional biomaterials as classified in the HCF regime.…”

Section: Resultsmentioning

confidence: 99%

“…Today, the use of new biomaterials in the manufacturing of medical devices (MDs) in the world is of great relevance, as reducing the environmental impact of extracting and refining currently popular elements such as titanium (Ti) is an important goal [1]. Currently, the potential of magnesium (Mg) as a base material for alloying with essential and nutritional elements such as Ca, Zn, and REEs is being widely investigated [2][3][4][5][6]. The advantages and effects of its use have already been evaluated in vivo by different programs and organizations throughout the world [7][8][9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Effect of sterilization on 3-point dynamic response to in vitro bending of an Mg implant.

Becerra

Rodríguez

Arroyo

et al. 2021

Preprint

View full text Add to dashboard Cite

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

show abstract

A lean magnesium–zinc–calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model

Cited by 54 publications

References 51 publications

Bioresorbable Magnesium-Based Alloys as Novel Biomaterials in Oral Bone Regeneration: General Review and Clinical Perspectives

Bioresorbable Magnesium-Based Alloys as Novel Biomaterials in Oral Bone Regeneration: General Review and Clinical Perspectives

Effect of Sterilization on 3-point Dynamic Response to in Vitro Bending of an Mg Implant

Effect of sterilization on 3-point dynamic response to in vitro bending of an Mg implant.

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