Department of Mechanical Engineering, University of Colorado Denver, Denver, CO, USA.
Parker H. Petit Institute for Bioengineering & Bioscience, Georgia Institute of Technology, Atlanta, GA, USA; George W. Woodruff School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.
J Mech Behav Biomed Mater. 2018 Apr;80:68-76. doi: 10.1016/j.jmbbm.2018.01.017.
Osseointegration of load-bearing orthopaedic implants, including interbody fusion devices, is critical to long-term biomechanical functionality. Mechanical loads are a key regulator of bone tissue remodeling and maintenance, and stress-shielding due to metal orthopaedic implants being much stiffer than bone has been implicated in clinical observations of long-term bone loss in tissue adjacent to implants. Porous features that accommodate bone ingrowth have improved implant fixation in the short term, but long-term retrieval studies have sometimes demonstrated limited, superficial ingrowth into the pore layer of metal implants and aseptic loosening remains a problem for a subset of patients. Polyether-ether-ketone (PEEK) is a widely used orthopaedic material with an elastic modulus more similar to bone than metals, and a manufacturing process to form porous PEEK was recently developed to allow bone ingrowth while preserving strength for load-bearing applications. To investigate the biomechanical implications of porous PEEK compared to porous metals, we analyzed finite element (FE) models of the pore structure-bone interface using two clinically available implants with high (> 60%) porosity, one being constructed from PEEK and the other from electron beam 3D-printed titanium (Ti). The objective of this study was to investigate how porous PEEK and porous Ti mechanical properties affect load sharing with bone within the porous architectures over time. Porous PEEK substantially increased the load share transferred to ingrown bone compared to porous Ti under compression (i.e. at 4 weeks: PEEK = 66%; Ti = 13%), tension (PEEK = 71%; Ti = 12%), and shear (PEEK = 68%; Ti = 9%) at all time points of simulated bone ingrowth. Applying PEEK mechanical properties to the Ti implant geometry and vice versa demonstrated that the observed increases in load sharing with PEEK were primarily due to differences in intrinsic elastic modulus and not pore architecture (i.e. 4 weeks, compression: PEEK material/Ti geometry = 53%; Ti material/PEEK geometry = 12%). Additionally, local tissue energy effective strains on bone tissue adjacent to the implant under spinal load magnitudes were over two-fold higher with porous PEEK than porous Ti (i.e. 4 weeks, compression: PEEK = 784 ± 351 microstrain; Ti = 180 ± 300 microstrain; and 12 weeks, compression: PEEK = 298 ± 88 microstrain; Ti = 121 ± 49 microstrain). The higher local strains on bone tissue in the PEEK pore structure were below previously established thresholds for bone damage but in the range necessary for physiological bone maintenance and adaptation. Placing these strain magnitudes in the context of literature on bone adaptation to mechanical loads, this study suggests that porous PEEK structures may provide a more favorable mechanical environment for bone formation and maintenance under spinal load magnitudes than currently available porous 3D-printed Ti, regardless of the level of bone ingrowth.
承重骨科植入物(包括椎间融合器)的骨整合对于长期生物力学功能至关重要。机械负荷是骨组织重塑和维持的关键调节剂,由于金属骨科植入物比骨硬得多,因此导致的应力屏蔽已在长期观察到的植入物周围组织骨丢失的临床观察中得到证实。具有容纳骨长入的多孔特征可在短期内改善植入物固定,但长期检索研究有时表明金属植入物的孔层中仅有限的、表面的长入,并且对于一部分患者来说,无菌性松动仍然是一个问题。聚醚醚酮(PEEK)是一种广泛使用的骨科材料,其弹性模量比金属更接近骨骼,并且最近开发了一种用于形成多孔 PEEK 的制造工艺,该工艺允许骨长入,同时保持用于承重应用的强度。为了研究与多孔金属相比,多孔 PEEK 的生物力学意义,我们使用两种具有高(>60%)孔隙率的临床可用植入物分析了孔结构-骨界面的有限元(FE)模型,一种是由 PEEK 制成,另一种是由电子束 3D 打印钛(Ti)制成。本研究的目的是研究多孔 PEEK 和多孔 Ti 机械性能如何随着时间的推移在多孔结构中影响与骨的载荷分担。与多孔 Ti 相比,在压缩(即 4 周:PEEK = 66%;Ti = 13%)、张力(PEEK = 71%;Ti = 12%)和剪切(PEEK = 68%;Ti = 9%)下,多孔 PEEK 可大大增加向植入物内长入骨的载荷分担。在模拟骨长入的所有时间点,将 PEEK 机械性能应用于 Ti 植入物几何形状和反之亦然,这表明观察到的 PEEK 载荷分担增加主要是由于固有弹性模量的差异而不是孔结构(即 4 周,压缩:PEEK 材料/Ti 几何形状 = 53%;Ti 材料/PEEK 几何形状 = 12%)。此外,在脊柱负荷下,与多孔 Ti 相比,植入物周围骨组织上的局部组织能量有效应变高出两倍以上(即 4 周,压缩:PEEK = 784 ± 351 微应变;Ti = 180 ± 300 微应变;和 12 周,压缩:PEEK = 298 ± 88 微应变;Ti = 121 ± 49 微应变)。PEEK 孔结构中骨组织上的较高局部应变低于先前建立的骨损伤阈值,但在生理骨维持和适应所需的范围内。将这些应变幅度置于关于骨对机械负荷适应的文献背景下,本研究表明,与目前可用的多孔 3D 打印 Ti 相比,多孔 PEEK 结构在脊柱负荷下可能为骨形成和维持提供更有利的机械环境,无论骨长入程度如何。