当前位置: X-MOL 学术J. Magnes. Alloys › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Peri‐implant gas accumulation in response to magnesium‐based musculoskeletal biomaterials: Reframing current evidence for preclinical research and clinical evaluation
Journal of Magnesium and Alloys ( IF 17.6 ) Pub Date : 2024-01-23 , DOI: 10.1016/j.jma.2024.01.023
Yu Sun , Heike Helmholz , Regine Willumeit-Römer

Historically, the rapid degradation and massive gas release from magnesium (Mg) implants resulted in severe emphysema and mechanical failure. With the advent of new alloys and surface treatment methods, optimized Mg implants have re-entered clinics since last decade with reliable performance. However, the optimization aims at slowing down the degradation process, rather than exemption of the gas release. This study involved a systematic evaluation of current preclinical and clinical evidence, regarding the physical signs, symptoms, radiological features, pathological findings and complications potentially associated with peri‑implant gas accumulation (PIGA) after musculoskeletal Mg implantation. The literature search identified 196 potentially relevant publications, and 51 papers were enrolled for further analysis, including 22 preclinical tests and 29 clinical studies published from 2005 to 2023. Various Mg-based materials have been evaluated in animal research, and the application of pure Mg and Mg alloys have been reported in clinical follow-ups involving multiple anatomical sites and musculoskeletal disorders. Soft tissue and intraosseous PIGA are common in both animal tests and clinical follow-ups, and potentially associated with certain adverse events. Radiological examinations especially micro-CT and clinical CT scans provide valuable information for quantitative and longitudinal analysis. While according to simulation tests involving Mg implantation and chemical processing, tissue fixation could lead to an increase in the volume of gas cavity, thus the results obtained from ex vivo imaging or histopathological evaluations should be interpreted with caution. There still lacks standardized procedures or consensus for both preclinical and clinical evaluation of PIGA. However, by providing focused insights into the topic, this evidence-based study will facilitate future animal tests and clinical evaluations, and support developing biocompatible Mg implants for the treatment of musculoskeletal disorders.



中文翻译:

镁基肌肉骨骼生物材料引起的种植体周围气体积累:重新构建临床前研究和临床评估的现有证据

从历史上看,镁(Mg)植入物的快速降解和大量气体释放导致严重的肺气肿和机械故障。随着新合金和表面处理方法的出现,优化的镁植入物自上个世纪以来以可靠的性能重新进入临床。然而,优化的目的是减缓降解过程,而不是免除气体释放。这项研究涉及对当前临床前和临床证据的系统评估,涉及肌肉骨骼镁植入后可能与种植体周围气体积累(PIGA)相关的身体体征、症状、放射学特征、病理学发现和并发症。文献检索确定了 196 篇潜在相关出版物,并纳入 51 篇论文进行进一步分析,其中包括 2005 年至 2023 年发表的 22 项临床前测试和 29 项临床研究。各种镁基材料已在动物研究中进行了评估,以及纯镁的应用镁合金在涉及多个解剖部位和肌肉骨骼疾病的临床随访中已有报道。软组织和骨内 PIGA 在动物试验和临床随访中都很常见,并且可能与某些不良事件相关。放射学检查尤其是显微 CT 和临床 CT 扫描为定量和纵向分析提供了有价值的信息。而根据涉及镁植入和化学处理的模拟测试,组织固定可能导致气腔体积增加,因此应谨慎解释离体成像或组织病理学评估获得的结果。PIGA 的临床前和临床评价仍缺乏标准化程序或共识。然而,通过提供对该主题的集中见解,这项基于证据的研究将促进未来的动物测试和临床评估,并支持开发用于治疗肌肉骨骼疾病的生物相容性镁植入物。

更新日期:2024-01-23
down
wechat
bug