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1 Vol. 34, No. 3, (2021) DOI: ISSN (Print), ISSN (Online) Paper 티타늄과탄소섬유강화 PEEK 로구성된요추유합술용연결봉의의공학적영향에대한비교분석 서혜성 * 강해성 * 전흥재 * Comparative Analysis of Biomechanical Behaviors on Lumbar with Titanium and Carbon Fiber Reinforced PEEK Connecting Rods for Fusion Surgery Hye-Sung Seo*, Hae-Seong Kang*, Houng-Jae Chun* ABSTRACT: The lumbar spinal fusion is a treatment performed to restore the stability of the degenerated lumbar. In this study, the intervertebral discs between two or more segments are removed and a bone graft is inserted to harden the segments. The pedicle screw system is inserted to vertebral bodies to fix two or more segments so that they can be firmly fused. In this study, a total of 7 patient-specific lumbar finite element models were created and pedicle screw systems were installed. The connecting rods made of titanium and CFR-PEEK was inserted to the generated models. Finite element analysis was conducted for four representative spine behaviors and statistical analysis was performed to investigate the biomechanical effects by the material properties of connecting rods. The intradiscal pressure of adjacent segments and the range of motion of the joints of each segment were investigated. In the subjects who used CFR- PEEK instead of Ti for connecting rods, the intradiscal pressure of adjacent segments tend to decrease and the range of motion of each segment tend to increase. However, no statistically significant difference in tendency was observed under all loading conditions. 초록 : 요추에퇴행이발생하였을때이를치료하기위해요추유합술이시행된다. 유합술은척추체사이의추간판을제거하고뼈그래프트등을삽입하여굳혀하나이상의분절을완전히고정시켜척추의안정성을복원한다. 둘이상의척추체가단단히유합될수있게끔척추체를고정하는수단으로척추경나사못과연결봉이환자의체내에삽입된다. 본연구에서는중증요추퇴행성질환의치료에쓰이는척추유합술에서사용하는척추경나사못구조물이적용된총 7개의환자맞춤형요추유한요소모델을생성하였다. 생성한모델에각각티타늄과 CFR- PEEK로구성된연결봉을구성하였다. 척추의 4가지대표적거동에대해유한요소해석과통계적분석을진행하여연결봉의재질이척추상태에미치는의공학적영향을조사하였다. 인접분절의추간판내압력과각분절의관절구동범위가의공학적영향을확인하기위한지표로사용되었다. 연결봉에 CFR-PEEK를사용한경우 Ti 연결봉에비해인접분절의추간판내압력은감소하였고각분절의관절구동범위는증가하였다. 그러나모든하중조건에서통계학적으로유의미한경향성차이는관찰되지않았다. Key Words: 복합재료 (Composite Material), 척주유합술 (Lumbar Fusion), 탄소섬유보강 PEEK(Carbon Fiber Reinforced PEEK), 통계해석 (Statistical Analysis), 유한요소해석 (Finite Element Analysis) Received 14 October 2020, received in revised form 27 April 2021, accepted 27 April 2021 * Department of Mechanical Engineering, Yonsei University, Seoul, Korea * Department of Mechanical Engineering, Yonsei University, Seoul, Korea, Corresponding author ( hjchun@yonsei.ac.kr)

2 Comparative Analysis of Biomechanical Behaviors on Lumbar with Titanium and Carbon Fiber Reinforced PEEK 서론 척추유합술이란추간판탈출증으로추간판이정상위치를벗어나척추관을압박하여극심한통증을유발하게된다 [1,2]. 통증이심한환자들을치료하기위한수술이다. 우선퇴행한요추분절의추간판을적출해내고그자리에유합체와케이지를삽입한다. 케이지는척추체간에접촉이일어나지않게하면서유합이될공간을확보해준다 [3]. 그후후방뼈에척추경나사못과유합술용연결봉을이용하여유합분절을고정한다. 그러나척추유합술은인접분절에새로운부하를발생시켜인접분절퇴행을유발하기도한다 [4]. 이는인접분절에극심한통증과운동기능의감소를야기하고심할경우유합분절외에도인접분절에추가적인수술적치료를필요로하게된다. 따라서척추유합술에서유합분절의유합률뿐만아니라인접분절에서의수술후변화역시중요한고려사항이되었다 [5]. 기존연구에서인접분절에서의압력변화와척추유합술용연결봉의물성간에상관관계를확인한바있다 [4,6]. 이러한연구들의결과에따르면티타늄은피질골보다 20배가량큰강성값을가지고있어유합분절에안정성을제공한다. 최근기술의발달과더불어환자개개인에맞는의료기기에대한관심역시많아지고있다. X-Ray 촬영뿐만아니라 CT 촬영과골밀도검사등으로환자에대한더욱자세한검진이가능해져과거보다더욱정밀하게환자의상태를파악할수있게되었다. 기존티타늄재질같이강성이큰재질의척추유합술용연결봉들은수술후유합분절에높은안정성을보장하였으나이렇게강성이큰연결봉의사용은유합분절의역학상태에정상상태에비하여극도로큰변화를발생시켜장기적으로인접분절퇴행을유발할수있다. 따라서최근에는강성이큰연결봉의사용에서생기는부작용들 (Adverse effect) 을줄이면서후방고정술을대체할수있는방법들을찾기위한연구들이진행되고있다. 그중연결봉의과도한강성으로인한운동성제한을완화하기위해유연한재료로제작한연결봉으로기존티타늄재료를대체하는연구들이진행된바있다 [7-10]. 이런유연한재질의연결봉을활용한연결봉은기존티타늄연결봉보다유연한분절들의움직임을제공하였고척추에서기존의응력집중현상들을줄여더욱균일하중전달을가능하게하였다. 티타늄보다유연한니티놀 (Nitinol) 및 polyetheretherketone (PEEK) 재질의연결봉의응력차단현상들을줄이며더욱균일한하중전달을가능하게하였다. PEEK 연결봉을사용한 in-vivo 연구에서티타늄연결봉들에비해실제인체역학적인하중상황에서더나은유연성을확인할수있었다. 그러나순수 PEEK 재질은강성이피질골보다약하기 에장기간적관점에서완전한대체물이라고보기에는어렵다. 이러한단점을보완하기위해 PEEK를탄소섬유를통해강화한탄소섬유강화 PEEK(Carbon fiber reinforced PEEK, CFR-PEEK) 가현재주목을받고있다. CFR-PEEK는 PEEK와마찬가지로인체에적합하지만 PEEK 보다강성과강도에서보다우수한성능을보인다. 본연구에서는우선대상이되는정상인 7명의 CT 사진을기반으로제작한척추전산모델에척추경나사못과연결봉을삽입하여수술후의척추모델을만들고티타늄과 CFR-PEEK 를연결봉재질로설정한다. 이후유한요소해석을통해획득한결과에서연결봉재질에따른통계적차이를분석하고자한다. 2. 모델구축및해석 2.1 정상모델구축요추전산모델제작을위해병리학적으로이상이없는 7명의피험자로부터 CT 사진을획득하였다. CT 사진을기반으로 Mimics 프로그램을사용하여 CT 사진을제자리에배열하는과정으로 Model Extraction, Model Selection, Model Modifying을수행하여요추 L3-L5의 3D 전산모델을제작하고 Mesh 및해석작업을진행하였다. Fig. 1. Intact finite element model of L3-L5 2.2 물성본연구에서각요소에사용된물성은기존연구에서얻은값으로부터설정되었다 [5,11-14]. 사용된물성은다음과같다.

3 188 Hye-Sung Seo, Hae-Seong Kang, Houng-Jae Chun Table 1. Material Properties Component Cortical Cancellous Young's Modulus [MPa] Ex=11,300, Ey=11,300, Ez=22,800 Gx=3800, Gy=5400, Gz=5400 Ex=11,300, Ey=11,300, Ez=22,800 Gx=3800, Gy=5400, Gz=5400 Poisson's ratio vxy=0.484 vxz=0.203 vyz=0.203 vxy=0.484 vxz=0.203 vyz=0.203 Posterior Nucleus pulposus Annulus fibrosus (Ground substance) Annulus fiber Facet Anterior longitudinal 7.8 (<12%), 20 (>12%) 0.3 Posterior longitudinal 10 (<11%), 20 (>11%) 0.3 Ligamentum flavum 15 (<6.2%), 19.5 (>6.2%) 0.3 Capsular 7.5 (<25%), 32.9 (>25%) 0.3 Interspinous 10 (<14%), 11.6 (>14%) 0.3 Supra spinous 8 (<20%), 15 (>20%) 0.3 Intertransverse 10 (<18%), 58.7 (>18%) 요추유합수술후모델구축수술후상태의구현을위해구축한정상인요추모델을기반으로유합술이적용된모델을제작하였다. L4-L5 사이의 Supraspinous, Interspinous, Flavum, Posterior Longitudinal 인대를제거하였다. 두척추체사이의추간판이완전히제거되었으며 PEEK제케이지가삽입되었다. 해면골의혈액이 Bonegraft와척추체사이의유합을촉진하므로실제수술과같이 L4 밑면의종판과 L5 윗면의종판을제거하였다. 척추경나사못은후방골에 Sagittal plane에서 10 o 방향의각을이루도록삽입하였다. 척추경나사못의나사산은못형태처럼단순화하였다. 척추경나사못와척추체사이완벽한 Bony fusion을구현하기위해척추체의나사구멍표면의노드들과척추경나사못의접촉면에서의노드들을 Node sharing을통해일치시켰다. 척추경나사못의직경은 5.0 mm, 길이는 40 mm이며척추경나사못 Head 의직경은 6.5 mm이고 10 mm이다. 척추경나사못의재료는기존의연구처럼티타늄으로하였다. 연결봉은티타늄과 CFR-PEEK를각각적용하였다. CFR-PEEK는체적비 30% 의단섬유를사용하였다. 피질골과척추체종판은 8노드 3차원연속체요소 (C3D8) 를사용하여제작되었다. 인대는 2노드 3차원트러스요소 (T3D2) 를통해생성하였으며, 인장하중에만작용하게끔설 Fig. 2. Finite element model of treated lumbar; (a) Cage with bonegraft inside (b) Pedical screw, (c) The spinal fixation rod made of Ti 정하였다. 해면골과후방골은 4노드사면체요소 (C3D4) 로구성하였으며추간판은 4노드사변형 (SFM3D4), 하이브리드 8노드 3차원연속체 (C3D8H) 요소를통해구현되었다. Hypermesh 2017을사용해요추유한요소모델을생성하였다. 모든모델은 Abaqus를통해유한요소해석을진행하였다. 2.4 경계조건및하중조건수술전후모델양측에동일한하중및경계조건을부과하여유한요소해석을진행하였다. 경계조건으로 L5 하부종판의하단면의모든노드의 6개변위를완전히구속하였다. 하중조건은운동에따른모멘트와상체하중에의한하중을동시에적용하였다. 척추체 L3 상부종판에있는노드들을커플링노드로지정하여 Reference point를만들고커플링노드들과연결해주었다. 이를통해 Reference point에가해지는 Moment는커플링요소들로전달된다. 7.5 Nm의 Fig. 3. Loading conditions used in this study; (a) Flexion (b) Extension (c) Lateral (d) Axial

4 Comparative Analysis of Biomechanical Behaviors on Lumbar with Titanium and Carbon Fiber Reinforced PEEK Flexion, 7.5 Nm 의 Extension, 7.5 Nm 의 Lateral bending 그리고 7.5 Nm 의 Torsion 이가해진다. 상체의무게를표현하기위하여 400 N 의수직하중을가하였다. 수직하중은 L3- L5 각척추체의각무게중심에작성된 Reference point 를따라 Following load 로설정하였다. 2.5 결과분석본연구에서유한요소모델은 7명에대하여티타늄연결봉적용모델, CFR-PEEK 연결봉적용모델 3 종류로총 14개가작성되었다. 그룹간의통계적으로유의미한차이를조사하기위해 Mann Whitney U-test 통계분석을실시하였다. 이는표본크기가작고모집단에대한정보가부족한경우에실시되는방법이다. 수술을진행한 L3-L4, L4-L5 두분절에대하여증가할경우요추추간판탈출증 (Herniation of intervertebral disk) 및퇴행성추간판의발생확률이증가할수있는추간판내압력 (Intradiscal pressure, IDP) 와특정관절또는신체부위주변의운동량을측정하는분절운동성 (Range of motion, ROM) 을각각조사하고통계적으로유의미한차이가있는지를분석하였다. Table 2. Changes of IDP and ROM of segments under Flexion Table 3. Changes of IDP and ROM of segments under Extension Table 4. Changes of IDP and ROM of segments under Bending Table 5. Changes of IDP and ROM of segments under Torsion Fig. 4. Geometric parameters in Lumbar; (a) Upper width, (b) Lower width, (c) Upper depth, (d) Lower depth, (e) Anterior height, (f) Posterior height, (g) anterior disc height, (h) posterior disc height 3. 결과 대부분환자에서유합술연결봉의재질이 CFR-PEEK일때 Ti인경우에비해 L3-L4 분절의 IDP는감소하였고분절에서 ROM은증가하였다. 다음은 7명의환자에대하여각분절에서 IDP 및 ROM의변화량을백분율로나타낸것이다. 비교이후위값에대하여통계적으로유의미성을분석하였다. 다음 Table 6는하중조건에따른 IDP 및 ROM 2종에대하여 Mann-Whitney U-test를실시한결과다 통계적분석을실시한결과모든조건에서유의확률은 0.05 이상이었다. 이결과는 Ti 재질의 Rod를 CFR-PEEK로교체하는것이 IDP 및 ROM에서보다나은경향을보임에도통계적으로유의미한변화를발생하지는않음을의미한다.

5 190 Hye-Sung Seo, Hae-Seong Kang, Houng-Jae Chun Table 6. Changes of IDP and ROM of segments under loading conditions Case Significance probability 4. 결론 본연구에서는척추경나사못체계가삽입된 7개의환자맞춤형요추유한요소모델을생성하고연결봉재질로 Ti 와 CFR-PEEK를각각적용한후유한요소해석을진행하여척추경나사못재질이요추에미치는의공학적영향을조사하였다. 이후통계적기법을활용한비교를통해재질에따른유의미한영향의여부를분석하였다. 강성이낮은 CFR-PEEK 연결봉을사용한환자들은 Ti에비해인접분절 IDP값은낮아지고모든분절에서 ROM값은높아지는경향이있었다. 그러나 Mann-whitney U-test 결과두그룹사이의귀무가설은기각되지않아 CFR-PEEK 재질의사용에따른의공학적효과가통계적인수준에서유의미한것은아님을확인하였다. 기존연구들에서나타났듯이연결봉의강성이낮아지는경우인접분절퇴행에영향을줄수있는주요한의공학적지표들이개선되는경향을확인할수있었다. 그럼에도불구하고 Ti 재질이 CFR-PEEK로교체되는경우의의공학적개선이통계학적으로유의미한수준에는이르지못하였으므로보다유의미한수준의차이를얻기위해연결봉에적합한재질에대하여후속연구가필요할수있다. 선행연구사례에따르면유한요소해석이임상의사결정을용이하게할수있으며, 기계적특성과뼈의구조를정밀하게결정하고보다현실적인하중예측을통해유한요소법결과를환자치료및고정체설계개발에효과적으로활용할수있다고보여진다 [15,16]. 후 Flexion Extension Lateral bending Torsion 기 L3-L4 IDP L3-L4 ROM L4-L5 ROM L3-L4 IDP L3-L4 ROM L4-L5 ROM L3-L4 IDP L3-L4 ROM L4-L5 ROM L3-L4 IDP L3-L4 ROM L4-L5 ROM 이연구는 2016 년도정부의재원으로한국연구재단의지원을받아수행된기초연구사업입니다 (No.2016R1A2B ). REFERENCES 1. Qi, L., Li, M., Zhang, S., Xue, J., and Si, H., Comparative Effectiveness of PEEK Rods Versus Titanium Alloy Rods in Lumbar Fusion: A Preliminary Report, Acta Neurochirurgica, Vol. 155, No. 7, 2013, pp Chen, F., Ou, H., Gatea, S., and Long, H., Hot Tensile Fracture Characteristics and Constitutive Modelling of Polyether-etherketone (PEEK), Polymer Testing, Vol. 63, 2017, pp Niinomi, M., and Nakai, M., Titanium-based Biomaterials for Preventing Stress Shielding between Implant Devices and Bone, International Journal of Biomaterials, Vol. 2011, No. 1-2, Kim, H.J., Kang, K.T., Chun, H.J., Lee, C.K., Chang, B.S., and Yeom, J.S., The Influence of Intrinsic Disc Degeneration of the Adjacent Segments on Its Stress Distribution after One-level Lumbar Fusion, European Spine Journal, Vol. 24, No. 4, 2015, pp Castro-Mateos, I., Pozo, J.M., Lazary, A., and Frangi, A.F., Automatic Construction of Patient-specific Finite-element Mesh of the Spine from IVDs and Vertebra Segmentations.In Medical Imaging 2016: Biomedical Applications in Molecular, Structural, and Functional Imaging, International Society for Optics and Photonics, Vol. 9788, 2016, pp U. 6. Hak, D.J., Mauffrey, C., Seligson, D., and Lindeque, B., Use of Carbon-fiber-reinforced Composite Implants in Orthopedic Surgery, Orthopedics, Vol. 37, No. 12, 2014, pp Shirazi-Adl, S.A., Shrivastava, S.C., and Ahmed, A.M., Stress Analysis of the Lumbar Disc-body Unit in Compression.A Three-dimensional Nonlinear Finite Element Study, Spine, Vol. 9, No. 2, 1984, pp Pintar, F.A., Yoganandan, N., Myers, T., Elhagediab, A., and Sances, A. Jr., Biomechanical Properties of Human Lumbar Spine Ligaments, Journal of Biomechanics, Vol. 25, No. 11, 1992, pp Wu, H.C., and Yao, R.F., Mechanical Behavior of the Human Annulus Fibrosus, Journal of Biomechanics, Vol. 9, No. 1, 1976, pp Lu, Y., Rosenau, E., Paetzold, H., Klein, A., Püschel, K., Morlock, M.M., and Huber, G., Strain Changes on the Cortical Shell of Vertebral Bodies due to Spine Ageing: A Parametric Study Using a Finite Element Model Evaluated by Strain Measurements, Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, Vol. 227, No. 12, 2013, pp Wilkowska, W., Gaul, S., and Ziefle, M., In Symposium of the Austrian HCI and Usability Engineering Group, Springer, Berlin, Heidelberg, 2010, pp Ziefle, M., and Schaar, A.K., Gender Differences in Acceptance and Attitudes Towards an Invasive Medical Stent, Electronic Journal of Health Informatics, Vol. 6, No. 2, 2011, pp Modic, M.T., Obuchowski, N.A., Ross, J.S., Brant-Zawadzki, M.N., Grooff, P.N., Mazanec, D.J., and Benzel, E.C., Acute Low Back Pain and Radiculopathy: MR Imaging Findings and Their Prognostic Role and Effect on Outcome, Neuroradiology,

6 Comparative Analysis of Biomechanical Behaviors on Lumbar with Titanium and Carbon Fiber Reinforced PEEK Vol. 237, No. 2, 2005, pp Atlas, S.J., Keller, R.B., Chang, Y.C., Deyo, R.A., and Singer, D.E., Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation: Five-Year Outcomes from the Maine Lumbar Spine Study, Spine, Vol. 26, No. 10, 2001, pp Liu, Y., Wang, Z., Liu, M., Yin, X., Liu, J., Zhao, J., and Liu, P., Biomechanical Influence of the Surgical Approaches, Implant Length and Density in Stabilizing Ankylosing Spondylitis Cervical Spine Fracture, Scientific Reports, Vol. 11, Article No. 6023, Parashar, S.K., and Sharma, J.K., A Review on Application of Finite Elementmodelling in Bone Biomechanics, Perspectives in Science, Vol. 8, 2016, pp

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