In vivo evaluation of a magnesium-based degradable intramedullary nailing system in a sheep model

Rössig, Christina; Angrisani, Nina; Helmecke, Patrick; Besdo, Silke; Seitz, Jan‐Marten; Welke, Bastian; Fedchenko, Nickolay; Kock, H.; Reifenrath, Janin

doi:10.1016/j.actbio.2015.07.025

Cited by 84 publications

(96 citation statements)

References 104 publications

(128 reference statements)

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“…Thus, the increased callus formation mediated by intramedullary Mg2Ag implants during fracture healing in mice is probably due to both an increase in bone formation and a decrease in bone resorption. These findings therefore strongly suggest the suitability of degradable Mg2Ag implants to promote long bone fracture healing in mice and are consistent with studies reporting positive effects of Mg implants on osteoblasts and bone formation [12][13][14]31,36,37]. However, we also noticed that Mg2Ag implants caused alterations of the shape of long bones under non-fracture and fracture conditions.…”

Section: Discussionsupporting

confidence: 79%

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Jähn¹,

Saito

Taipaleenmäki

et al. 2016

Acta Biomaterialia

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Intramedullary stabilization is frequently used to treat long bone fractures. Implants usually remain unless complications arise. Since implant removal can become technically very challenging with the potential to cause further tissue damage, biodegradable materials are emerging as alternative options. Magnesium (Mg)-based biodegradable implants have a controllable degradation rate and good tissue compatibility, which makes them attractive for musculoskeletal research. Here we report for the first time the implantation of intramedullary nails made of an Mg alloy containing 2% silver (Mg2Ag) into intact and fractured femora of mice. Prior in vitro analyses revealed an inhibitory effect of Mg2Ag degradation products on osteoclast differentiation and function with no impair of osteoblast function. In vivo, Mg2Ag implants degraded under non-fracture and fracture conditions within 210 days and 133 days, respectively. During fracture repair, osteoblast function and subsequent bone formation were enhanced, while osteoclast activity and bone resorption were decreased, leading to an augmented callus formation. We observed a widening of the femoral shaft under steady state and regenerating conditions, which was at least in part due to an uncoupled bone remodeling. However, Mg2Ag implants did not cause any systemic adverse effects. These data suggest that Mg2Ag implants might be promising for intramedullary fixation of long bone fractures, a novel concept that has to be further investigated in future studies.

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Section: Discussionsupporting

confidence: 79%

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Jähn¹,

Saito

Taipaleenmäki

et al. 2016

Acta Biomaterialia

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“…During the degradation process, these alloying elements can form complexes in the direct implant environment or distribute systemically via the circulation. Accumulation predominantly occurs in the excretory organs (liver and kidney), but the spleen can also be affected . Therefore, systemic toxicity, as well as local effects, must be considered during biocompatibility testing of new degradable materials.…”

Section: In Vivo Testing Of Magnesium Alloysmentioning

confidence: 99%

“…For orthotopic implant locations, the rat is superior, due to its size and consequent applicability of implant material in bony structures. When more complex, patient adapted implants, like plate screw systems, interlocked intramedullary nailing systems or intranasal stents, are the focus of interest, a larger animal model can be necessary, as production engineering and applicability might be limited in miniaturized devices, and the geometry will be more comparable to the later target application, which is predominately in humans. Another advantage of large animal models like the sheep and pig is their lower metabolism compared to mice and rats, which is also more comparable to humans.…”

Section: In Vivo Testing Of Magnesium Alloysmentioning

confidence: 99%

Magnesium alloys: A stony pathway from intensive research to clinical reality. Different test methods and approval‐related considerations

Willbold

Weizbauer

Loos³

et al. 2016

J Biomedical Materials Res

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The first degradable implant made of a magnesium alloy, a compression screw, was launched to the clinical market in March 2013. Many different complex considerations are required for the marketing authorization of degradable implant materials. This review gives an overview of existing and proposed standards for implant testing for marketing approval. Furthermore, different common in vitro and in vivo testing methods are discussed. In some cases, animal tests are inevitable to investigate the biological safety of a novel medical material. The choice of an appropriate animal model is as important as subsequent histological examination. Furthermore, this review focuses on the results of various mechanical tests to investigate the stability of implants for temporary use. All the above aspects are examined in the context of development and testing of magnesium-based biomaterials and their progress them from bench to bedside. A brief history of the first market launch of a magnesium-based degradable implant is given. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 329-347, 2017.

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“…The gas pockets around implantable devices were observed in human patients 14 as well as animal models. 17,19,48,49 Several papers studied the effects of surface modifications on the gas pocket formation. Fischerauer et al observed decrease in the gas pocket formation in the 1st 2 weeks postimplantation with the implants treated by micro-arc oxidation, however these differences were not significant and at weeks 3 and 4 the gas volume was higher than in the untreated group.…”

Section: Discussionmentioning

confidence: 99%

In vivo study of self‐assembled alkylsilane coated degradable magnesium devices

et al. 2018

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Magnesium (Mg) and its alloys are candidate materials for resorbable implantable devices, such as orthopedic devices or cardiovascular stents. Mg has a number advantages, including mechanical properties, light weight, its osteogenic effects and the fact that its degradation products are nontoxic and naturally present in the body. However, production of H gas during the corrosion reaction can cause formation of gas pockets at the implantation site, posing a barrier to clinical applications of Mg. It is therefore desirable to develop methods to control corrosion rate and gas pocket formation around the implants. Here we evaluate the potential of self-assembled multilayer alkylsilane (AS) coatings to control Mg device corrosion and formation of gas pockets in vivo and to assess effects of the AS coatings on the surrounding tissues in a subcutaneous mouse model over a 6 weeks' period. The coating significantly slowed down corrosion and gas pocket formation as evidenced by smaller gas pockets around the AS coated implants (ANOVA; p = 0.013) and decrease in the weight loss values (t test; p = 0.07). Importantly, the microCT and profilometry analyses demonstrated that the coating inhibited the pitting corrosion. Specifically, the roughness of the coated samples was ∼30% lower than uncoated specimen (p = 0.02). Histological assessment of the tissues under the implant revealed no inflammation or foreign body reaction. Overall, our results demonstrate the feasibility of use of the seld assembled AS coatings for reduction of gas pocket formation around the resorbable Mg devices. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2018.

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In vivo evaluation of a magnesium-based degradable intramedullary nailing system in a sheep model

Cited by 84 publications

References 104 publications

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Magnesium alloys: A stony pathway from intensive research to clinical reality. Different test methods and approval‐related considerations

In vivo study of self‐assembled alkylsilane coated degradable magnesium devices

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