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使用 3D 黏结剂喷射颅骨模型评估颅骨修补术中患者专用丙烯酸假体的植入物特性、安全性和临床疗效:一项初步研究。

Evaluation of implant properties, safety profile and clinical efficacy of patient-specific acrylic prosthesis in cranioplasty using 3D binderjet printed cranium model: A pilot study.

机构信息

Materials Research Center, Indian Institute of Science, Bangalore 560012, India; Center for BioSystems Science and Engineering, Indian Institute of Science, Bangalore 560012, India.

Materials Research Center, Indian Institute of Science, Bangalore 560012, India.

出版信息

J Clin Neurosci. 2021 Mar;85:132-142. doi: 10.1016/j.jocn.2020.12.020. Epub 2021 Jan 23.

Abstract

UNLABELLED

There exists a significant demand to develop patient-specific prosthesis in reconstruction of cranial vaults after decompressive craniectomy. we report here, the outcomes of an unicentric pilot study on acrylic cranial prosthesis fabricated using a 3D printed cranium model with its clinically relevant mechanical properties.

METHODS

The semi-crystalline polymethyl methacrylate (PMMA) implants, shaped to the cranial defects of 3D printed cranium model, were implanted in 10 patients (mean age, 40.8 ± 14.8 years). A binderjet 3D printer was used to create patient-specific mould and PMMA was casted to fabricate prosthesis which was analyzed for microstructure and properties. Patients were followed up for allergy, infection and cosmesis for a period of 6 months.

RESULTS

As-cast PMMA flap exhibited hardness of 15.8 ± 0.24Hv, tensile strength of 30.7 ± 3.9 MPa and elastic modulus of 1.5 ± 0.1 GPa. 3D microstructure of the semi-crystalline acrylic implant revealed 2.5-15 µm spherical isolated pores. The mean area of the calvarial defect in craniectomy patients was 94.7 ± 17.4 cm. We achieved a cranial index of symmetry (CIS -%) of 94.5 ± 3.9, while the average post-operative Glasgow outcome scale (GOS) score recorded was 4.2 ± 0.9.

CONCLUSIONS

3D printing based patient-specific design and fabrication of acrylic cranioplasty implant is safe and achieves acceptable cosmetic and clinical outcomes in patients with decompressive craniectomy. Our study ensured clinically acceptable structural and mechanical properties of implanted PMMA, suggesting that a low cost 3D printer based PMMA flap is an affordable option for cranioplasty in resource constrained settings.

摘要

未加标签

在去骨瓣减压术后重建颅盖存在对定制假体的巨大需求。我们在此报告,使用具有临床相关机械性能的 3D 打印颅骨模型制造丙烯酸颅骨假体的单中心试点研究的结果。

方法

将形状为 3D 打印颅骨模型颅骨缺损的半结晶聚甲基丙烯酸甲酯(PMMA)植入物植入 10 例患者(平均年龄 40.8 ± 14.8 岁)。使用粘合剂喷射 3D 打印机创建患者特定的模具,并浇铸 PMMA 以制造假体,对其进行微观结构和性能分析。对患者进行为期 6 个月的过敏、感染和美容随访。

结果

铸型 PMMA 皮瓣硬度为 15.8 ± 0.24Hv,拉伸强度为 30.7 ± 3.9MPa,弹性模量为 1.5 ± 0.1GPa。半结晶丙烯酸植入物的 3D 微观结构显示出 2.5-15µm 球形孤立孔。去骨瓣减压术后患者颅骨缺损的平均面积为 94.7 ± 17.4cm。我们实现了 94.5 ± 3.9 的颅指数对称性(CIS-%),而平均术后格拉斯哥结局量表(GOS)评分记录为 4.2 ± 0.9。

结论

基于 3D 打印的患者特定设计和制造丙烯酸颅骨修复术植入物是安全的,并在去骨瓣减压术后患者中获得可接受的美容和临床结果。我们的研究确保了植入 PMMA 的临床可接受的结构和机械性能,表明基于低成本 3D 打印机的 PMMA 皮瓣是资源有限环境中颅骨修复术的一种经济实惠的选择。

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