Service de chirurgie osseuse, CHU d'Angers, 4, rue Larrey, 49933 Angers cedex 9, France.
Service de chirurgie osseuse, CHU d'Angers, 4, rue Larrey, 49933 Angers cedex 9, France.
Orthop Traumatol Surg Res. 2024 Dec;110(8):103849. doi: 10.1016/j.otsr.2024.103849. Epub 2024 Feb 28.
3D printing, which is becoming ever more widespread in orthopedic surgery, requires specific materials. Polylactic acid (PLA) is the most widely used in general-purpose 3D printing, but its thermosensitivity can be incompatible with sterilization. Even so, it is easy to use, inexpensive, non-toxic and biodegradable. Controversy surrounds its use. 3D printing of directly sterilizable PLA parts according to surgeons' needs would be highly advantageous, but doubts remain. We therefore performed an in vitro study to determine which PLAs resist steam sterilization regarding deformation.
The study hypothesis was that, depending on make and shape, 3D-printed PLA parts can retain their properties after steam sterilization.
We selected 4 makes of PLA and used each to print 4 simple cubes and 4 complex shapes corresponding to cuboid bones. They were subjected to steam sterilization under normal French hospital conditions. The size of the cubes was measured before and after sterilization, using a digital caliper.
Cuboid parts in HT-PLA and PLA-WANAO showed mean deformation of -0.02mm and -0.4mm, respectively after sterilization, the differences being non-significant (p=0.679 and p=0.241, respectively). Cuboid parts in PLA-SUNLU and PLA-G3D showed significant mean deformation: respectively, -1.37mm (p=0.026) and -35.03mm (p>0.001). Cubes in all types of PLA showed significant mean deformation: HT-PLA, -0.61mm (p=0.004); PLA-SUNLU, -2.70mm (p=0.002); PLA-G3D, -28.64mm (p>0.001); and PLA-WANAO, -1.33mm (p=0.010).
The study confirmed recent findings that steam sterilization is feasible with certain PLA-printed parts, with deformations less than 1mm, and that choice of PLA is crucial for success. Computer-designed objects (here, cubes) did not resist sterilization without significant deformation. Analysis of resistance to various stresses was not performed, and therefore it cannot be claimed that the process could be used other than for printing anatomic parts. Use of 3D printing in French hospitals is probably a real source of innovation and improvement in care quality; however, a legal framework needs establishing for the use of 3D-printed parts, to ensure patient safety and promote research in this field.
III; prospective in vitro study.
3D 打印技术在骨科领域的应用越来越广泛,它需要特殊的材料。聚乳酸(PLA)是通用 3D 打印中使用最广泛的材料,但它的热敏性可能与消毒不相容。即便如此,它还是易于使用、价格低廉、无毒且可生物降解。对于 PLA 的使用存在争议。根据外科医生的需求,直接对可消毒的 PLA 零件进行 3D 打印将非常有利,但仍存在一些疑虑。因此,我们进行了一项体外研究,以确定哪些 PLA 在蒸汽消毒后仍能保持其性能。
研究假设是,根据制造和形状的不同,3D 打印的 PLA 零件在蒸汽消毒后可以保留其特性。
我们选择了 4 种 PLA,并分别使用它们打印 4 个简单的立方体和 4 个对应于长方体骨骼的复杂形状。它们在法国医院的常规蒸汽消毒条件下进行了消毒。使用数字卡尺测量消毒前后立方体的尺寸。
在 HT-PLA 和 PLA-WANAO 中,消毒后的长方体零件的平均变形分别为-0.02mm 和-0.4mm,差异无统计学意义(分别为 p=0.679 和 p=0.241)。PLA-SUNLU 和 PLA-G3D 中的长方体零件的平均变形明显:分别为-1.37mm(p=0.026)和-35.03mm(p>0.001)。所有类型 PLA 中的立方体都显示出明显的平均变形:HT-PLA,-0.61mm(p=0.004);PLA-SUNLU,-2.70mm(p=0.002);PLA-G3D,-28.64mm(p>0.001);PLA-WANAO,-1.33mm(p=0.010)。
该研究证实了最近的发现,即某些 PLA 打印部件可以通过蒸汽消毒,变形小于 1mm,并且 PLA 的选择对于成功至关重要。未经显著变形的计算机设计物体(此处为立方体)无法抵抗消毒。没有对各种应力的阻力进行分析,因此不能声称该过程除了用于打印解剖部位外还可以用于其他用途。3D 打印在法国医院的使用可能是创新和提高护理质量的真正来源;然而,需要建立一个使用 3D 打印部件的法律框架,以确保患者安全并促进该领域的研究。
III;前瞻性体外研究。