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Gas formation and biological effects of biodegradable magnesium in a preclinical and clinical observation.

ABSTRACT: Magnesium alloys are biodegradable metals receiving increasing attention, but the clinical applications of these materials are delayed by concerns over the rapid corrosion rate and gas formation. Unlike corrosion, which weakens mechanical properties, the gas formation issue has received little attention. Therefore, we evaluated the gas formation and biological effects for Mg implants through preclinical (immersed in Earle's balanced salt solution and in vivo) and clinical studies. The immersion test examined the gas volume and composition. The in vivo study also examined gas volume and histological analysis. The clinical study examined the gas volume and safety after Mg screw metatarsal fixation. Gas was mainly composed of H2, CO and CO2. Maximum volumes of gas formed after 5 days for in vivo and 7 days in clinical study. Within the clinical examination, two superficial wound complications healed with local wound care. Osteolytic lesions in the surrounding metaphysis of the Mg screw insertion developed in all cases and union occurred at 3 months. Mg implants released gas with variable volumes and composition (H2, CO, and CO2), with no long-term toxic effects on the surrounding tissue. The implants enabled bone healing, although complications of wound breakdown and osteolytic lesions developed.

SUBMITTER: Kim YK

PROVIDER: S-EPMC5917435 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Gas formation and biological effects of biodegradable magnesium in a preclinical and clinical observation.

Kim Yu-Kyoung YK Lee Kwang-Bok KB Kim Seo-Young SY Bode Ken K Jang Yong-Seok YS Kwon Tae-Young TY Jeon Moo Heon MH Lee Min-Ho MH

Science and technology of advanced materials 20180409 1

Magnesium alloys are biodegradable metals receiving increasing attention, but the clinical applications of these materials are delayed by concerns over the rapid corrosion rate and gas formation. Unlike corrosion, which weakens mechanical properties, the gas formation issue has received little attention. Therefore, we evaluated the gas formation and biological effects for Mg implants through preclinical (immersed in Earle's balanced salt solution and <i>in vivo</i>) and clinical studies. The imm ...[more]

PMID: 29707071

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Project description:Clinical applications of magnesium (Mg)-based screws have reported gas cavity formation in the surrounding tissue, which sometimes delays the fixation of the bone fracture. The gas cavity formation is considered to depend on the balance between hydrogen generation by Mg corrosion reacting with water in the body fluid and its diffusion into the surrounding tissue by capillary flow. In order to understand the gas cavity formation behavior by Mg-based material implantation, we developed a new in vitro model system to recreate this cavity formation phenomenon: the hydrogen generation by corrosion and its diffusion into the medium. A model tissue is prepared by gelation of the cell culture medium in a sterile condition. The immersion of Mg alloy samples was performed under 5% CO2 atmosphere with periodic observation by X-ray computed tomography, which enabled us to observe gas cavity growth up to 28 d. For demonstrating the usefulness of our model system, Mg alloy samples with different corrosion rates were prepared by a biodegradable polymer coating. AZ31 screws were spin-coated by poly-l-lactide (PLLA) and classified into three groups by their coating thickness as 1.0 ± 0.0, 1.6 ± 0.2, and 2.0 ± 0.1 μm (ave. ± s.d.). Upon their immersion into the model tissue, the gas cavity volumes formed were 1.57 ± 0.23, 1.06 ± 0.22, and 0.38 ± 0.09 mm3/mm2 for 1.0, 1.6, and 2.0 μm coating samples, having the weight loss of 20.2 ± 2.93, 18.5 ± 2.84, and 11.3 ± 3.54 μg/mm2, respectively (ave. ± s.d.). This result clearly indicates the dependence of gas cavity formation on the corrosion rate of the sample. The gas cavity volume was only 3.3∼7.5% of the total hydrogen gas volume estimated based on the weight loss of the samples at 28 d, which is in the range of those calculated from the clinical report (3.2∼9.4% at 4w). This system can be an effective tool to investigate the gas cavity formation behavior and contribute to understand the mechanisms and controlling factors of this phenomenon.

Dataset Information

Gas formation and biological effects of biodegradable magnesium in a preclinical and clinical observation.

Publications

Gas formation and biological effects of biodegradable magnesium in a preclinical and clinical observation.

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