Grygier Dominika, Kowalewski Piotr, Opałka Mariusz, Słowiński Jakub J, Dziubek Mateusz, Pyka Dariusz
Department of Vehicle Engineering, Faculty of Mechanical Engineering, Wroclaw University of Science and Technology, Smoluchowskiego 25 Str., 50-370 Wroclaw, Poland.
Orthoget Sp. z o.o., Muchoborska 18, 54-424 Wrocław, Poland.
J Funct Biomater. 2025 Jan 15;16(1):27. doi: 10.3390/jfb16010027.
This study focuses on the development and evaluation of the OrthoNail hybrid intramedullary implant for lower limb lengthening in patients requiring significant skeletal reconstruction. The implant addresses the challenges in load-bearing during rehabilitation, providing a robust solution that is capable of supporting physiological loads. Mechanical tests, including axial compression, tension, torsion, and 3,4-point bending, determined the implant's load capacity and fatigue resistance, while finite element analysis assessed stress distributions in bone tissue and around screw holes during single-leg stance, with boundary conditions derived from Orthoload database data. The OrthoNail implant demonstrated excellent mechanical stability, sustaining torsional loads of up to 19.36 Nm at maximum elongation (80 mm) and 17.16 Nm at zero elongation. Under axial compression, it withstood forces of up to 1400 N, maintaining structural integrity. Fatigue testing revealed resilience under dynamic loading conditions for over 1,000,000 cycles at a load of 500 N, with no mechanical failure or material degradation observed. Stress concentrations near screw holes indicate areas for potential optimization. The findings indicate that the OrthoNail implant demonstrates excellent mechanical stability and is well-suited for clinical application, enabling early full weight-bearing during rehabilitation.
本研究聚焦于用于需要进行重大骨骼重建的患者下肢延长的OrthoNail混合髓内植入物的研发与评估。该植入物解决了康复过程中承重方面的挑战,提供了一种能够承受生理负荷的强大解决方案。包括轴向压缩、拉伸、扭转以及三点和四点弯曲在内的力学测试确定了植入物的承载能力和抗疲劳性,而有限元分析评估了单腿站立期间骨组织和螺钉孔周围的应力分布,其边界条件源自OrthoLoad数据库数据。OrthoNail植入物表现出出色的机械稳定性,在最大伸长量(80毫米)时能承受高达19.36牛米的扭转负荷,在零伸长量时能承受17.16牛米的扭转负荷。在轴向压缩下,它能承受高达1400牛的力,保持结构完整性。疲劳测试表明,在500牛的负荷下动态加载条件下超过100万次循环具有弹性,未观察到机械故障或材料降解。螺钉孔附近的应力集中表明了潜在的优化区域。研究结果表明,OrthoNail植入物表现出出色的机械稳定性,非常适合临床应用,能够在康复期间早期实现完全负重。