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1 한국공작기계학회지 Vol.18 No pp. 321~327 Journal of the Korean Society of Machine Tool Engineers 자가확장형전방십자인대고정장치의고정특성에대한연구 김종대 +, 김홍건 * ( 논문접수일 , 심사완료일 ) A Study on the Fixation Characteristics of a Self-expansion Type ACL Fixation Device Jong-Dae Kim +, Hong-Gun Kim* Abstract This paper studied the influences of the main design parameter-the expansion angle and the material properties of the self-expansion anterior cruciate ligament fixation device on the contact condition with the bone and the initial stability of the device. Using finite element analysis, the stress distributions of the ring part of the device and the wall of the bone tunnel were calculated. And the micro-migration of the device by the pull-out force was calculated. From the analysis results, it was found that when designing the self-expansion type anterior cruciate ligament fixation device, it is desirable to use the material having higher Young s modulus and to design the fixation device that all wedges uniformly maintain contact with bone to obtain initial stability after operation. Key Words : Anterior cruciate ligament( 전방십자인대 ), ligament fixation device( 인대고정장치 ), micro-migration( 미세이동변위 ), finite element method( 유한요소법 ), bone tunnel( 뼈터널 ) 1. 서론 슬관절 (knee joint) 의안정성과운동을유지시켜주는인체구조물인전방십자인대는손상되었을경우그자체로완전하게재건되지않는것으로보고되어있다 (1). 따라서전방십자인대손상에대해수술적인재건이일반적인치료방법이다. 손상된전방십자인대를재건하기위한이식건으로는골- 슬개건-골과슬건이주로이용되고있다. 골-슬개건-골의장점은높은인장강도와강성그리고간섭나사를이용하여견고한초기고정력을제공하는데있으나공여부의이환율이높고, 시술후통증이나기능적불안정을유발시킬수있는단점을가지고있어슬건의이용이증가되고있다 (2). 슬건은공여부의이환율이골-슬개건-골보다낮고, 여러겹으로접어서사용할경우보다큰인장강 + 전주대학교기계자동차공학과 * 교신저자, 전주대학교기계자동차공학과 (hkim@jj.ac.kr) 주소 : 전주시완산구효자동 3가

2 김종대 김홍건 도와강성을갖는것으로보고되어있다. 그러나슬건은골- 슬개건-골과같은뼈블록을가지고있지않아치유기간이길어진다는단점을가지고있다 (3). 슬건을대퇴골터널에고정하기위해여러종류의고정장치들이개발되어왔다. 금속재질및생분해성재질의간섭나사는좋은고정강도를제공하지만터널축과의틀어짐으로인한고정강도저하, 이식건의빠짐이나찢김등의문제가발생한다 (4). 슬건을고정하는또다른방법으로는이식건을버튼이나봉에매달아고정시키는방법이있다. 이고정장치들은초기고정강도가매우높고, 이식건과뼈가원주방향으로접해있어, 생물학적인결합을용이할수있다는장점이있다 (5). 그러나이러한장치들은이식건이대퇴골터널내에서길이 (longitudinal) 방향과세로 (sagittal) 방향으로움직이므로시술부위의치유기간을지연시킬수있다 (3). 전방십자인대재건시술후재활치료에대한최근의경향은 Shelbourne과 Nitz가제안한가속재활훈련 (accelerated rehabilitation) 을채택하는추세이다. 이방법은수술직후관절운동과체중부하를강조하고있다 (6). 이훈련을수행하기위해전방십자인대재건에이용되는고정장치는최소 500N의 pull-out force에저항할수있어야한다 (7). 유한요소해석은공학분야에서광범위하게이용되고있으며, 생체역학분야에서도예외는아니다 (8). 최근 Kim 등은자가확장형전방십자인대고정장치를제안하였으며, 주요설계변수인고정장치의벌어진각도와링부위두께가뼈터널과접촉하는양상및초기고정안정성에미치는연구를수행하였다 (9). 이연구에서고정장치는재질이 Ti6Al4V인것으로가정되었으며다른재료에대해서는연구되지않았다. 임플란트용금속재료인 316L 스테인리스강이나 CoCr 합금은우수한기계적강도와탄성 (10) 으로인해자가확장형고정장치의재료로이용하는것이가능하다. 따라서본연구에서는티타늄합금외에임플란트용금속으로널리이용되는 316L 스테인리스강과 CoCr 합금을자가확장형인대고정장치에적용하여고정장치의뼈터널에의접촉특성및초기고정안정성을평가하고자한다. 2. 자가확장형전방십자인대고정장치구조 Fig. 1은자가확장형전방십자인대고정장치의모식도이다 (9). 이고정장치는그기능상크게 3부위로구분된다. Fig. 1의 A 부분은접선방향으로탄성변형이가능한링부위이다. 이부위의탄성변형은접선방향의탄성력을제공하여 코일스프링역할을수행할수있도록한다. Fig. 1의 B 부분은고정장치가대퇴골터널벽에접촉하는부분으로나사형태가아닌원주방향으로웨지형상의날카로운산을가지고있다. Fig. 1의 C 부분은인대를걸기위한고리부분이다. Fig. 2는고정장치의성능에영향을미치는주요설계변수와대퇴골터널에삽입하기위해움켜주는하중및초기안정성평가를위해적용하는 pull-out 하중을가하는지점을보여준다. Fig. 2에서와같이고정장치는시술전에는일정한각도로벌어져있다가대퇴골터널에삽입할때힘 F를가하여고정장치를움켜쥔다. 그다음대퇴골터널에삽입한다. 삽입후에움켜쥐었던힘을제거하면고정장치는탄성변형되었던링형상의 Fig. 1 A 부위가접선방향으로다시벌어지게된다. 이러한방식으로시술후에웨지형상의날카로운산이뼈과접촉하게된다. 이접촉력이수술후초기에인대를고정하는역할을수행한다. Coronal plane Sagittal plane Fig. 1 A three-dimensional view of a self-expansion type anterior cruciate ligament fixation device F θ P Fig. 2 Main design parameters and applied forces t R Wedge 1 Wedge 2 Wedge 3 Wedge 4 Wedge 5 F A B C 322

3 한국공작기계학회지 Vol.18 No 연구방법 본연구의목적은고정장치의링부위두계 t R 이 1.0mm인경우에대해초기벌어진각도와재료의기계적특성이고정장치의대퇴골터널과의접촉및초기고정안정성에미치는영향을유한요소해석을통해살펴보는것이다. Fig. 1의고정장치의링부위 A와웨지부위 B는기하학적으로각각세로평면 (sagittal plane) 과가로평면 (coronal plane) 에대해대칭이다. 또한고정장치는대퇴골모델의내부망상골 (cancellous bone) 에터널을형성하여삽입하는것으로가정하였다. 그러므로고정장치에의해역학적으로영향을받는부위만을고려하면고정장치가삽입된대퇴골터널부위는축대칭으로생각할수있다. 따라서본논문에서는고정장치와대퇴골의 1/4 유한요소모델을구성하여유한요소해석을수행하였다. 고정장치가삽입되는대퇴골의기하학적모델은인터넷에제공되는 3차원대퇴골모델을이용하였다 (11). 고정장치와뼈의유한요소모델링과해석은 ABAQUS 6.7-1을사용하였다. Fig. 3은고정장치와대퇴골의 1/4 유한요소모델을보여준다. 고정장치의웨지부위유한요소모델링에는 20-node quadratic brick(c3d20) 요소를사용하였고, 링부위와고리부위의유한요소모델링에는 10-node quadratic tetrahedron (C3D10) 요소를사용하였다. 뼈의경우고정장치웨지와접촉하는부위의유한요소모델링에는 20-node quadratic brick (C3D20) 요소를사용하였고, 나머지부위의유한요소모델링에는 10-node quadratic tetrahedron(c3d10) 요소를사용하였다. 고정장치모델링에는약 6,400개의요소를사용하였고, 대퇴골모델링에는약 8,300개의요소를사용하였다. 고정장치는각각 CoCr 합금과 316L 스테인리스강으로제작된 다고가정하였다. 고정장치의탄성계수와푸와송비 (Poisson s ratio) 는 CoCr 합금의경우각각 220GPa와 0.3으로그리고 316L 스테인리스강의경우 196GPa와 0.28로하였다 (12,13). 대퇴골모델의망상골에대한탄성계수는 2130MPa으로푸와송비는 0.3으로하였다 (14). 뼈와고정장치사이에정의되는마찰계수는고정장치의 pull-out 저항력에많은영향을미친다. 그러나이같은마찰계수를정하는것은쉽지않다. 통상적으로뼈와임플란트사이의마찰계수는실험값과모의실험값을비교하여정하거나임의로마찰계수를정하여해석을수행하였다 (15). 본논문에서는마찰계수 5.0을선정하여연구를수행하였다. 모의시험은실제시술을모사하기위한 3가지경우에대해수행되었다. 첫번째모의시험은고정장치웨지가대퇴골터널벽에닿지않을정도로고정장치를움켜쥐어고정장치의링부위에걸리는응력을해석하기위한것이다. 두번째모의시험은고정장치를움켜쥐었던힘을제거하였을때고정장치웨지가본터널벽에접촉하는양상을살펴보기위한것이다. 세번째모의시험은접촉이완료된고정장치에 pull-out force를적용하여초기고정안정성을살펴보기위한것이다. 첫번째모의시험에서는고정장치부위인 Fig. 3의 E와 F 변위를각각 1, 2, 3방향과 1방향에대해구속시켰다. 그리고뼈부위인 Fig. 3의 A는 1, 2, 3 방향의변위를구속하였고, Fig. 3의 B는 2방향의변위만을구속하였다. 그리고 Fig. 3의 C는 1방향의변위만을구속하였다. 두번째모의시험에서는첫번째모의시험에서와동일한경계조건을적용하였다. 세번째모의시험에서는뼈터널의중심축방향 (3방향) 으로 pull-out force를가하였다. 따라서고정장치부위인 Fig. 3의 E는 1과 2 방향에변위만을구속을하였다. 그리고 Fig. 3의 F부위와뼈에대해서는첫번째모의시험과동일한경계조건을적용하였다. B A E 4. 결과및고찰 Table 1 은모의시험시고정장치를대퇴골터널에삽입하 A Fig. 3 The quarter finite element model of fixation device and femur C F Table 1 Maximum Mises stresses on the ring part (MPa) θ Materials CoCr alloy L stainless steel

4 김종대 김홍건 Fig. 4 Stress distribution of the bone tunnel wall; the first wedge and θ=6 Fig. 5 Stress distribution of the bone tunnel wall; the third wedge and θ=6 Fig. 6 Stress distribution of the bone tunnel wall; the fifth wedge and θ=6 Fig. 7 Stress distribution of the bone tunnel wall; the first wedge and θ=10 Fig. 8 Stress distribution of the bone tunnel wall; the third wedge and θ=10 Fig. 9 Stress distribution of the bone tunnel wall; the fifth wedge and θ=10 324

5 한국공작기계학회지 Vol.18 No 기위해움켜쥐었을때링부위에걸리는최대 Mises 응력을보여준다. 316L 스테인리스강보다는 CoCr 합금이고정장치의벌어진각도 θ가커짐에따라최대응력이커짐을알수있다. 본연구에서고정장치의재질로가정한 CoCr 합금과 316L 스테인리스강의항복강도는각각 720MPa (13) 와 690MPa (11) 이다. Table 1로부터고정장치의벌어진각도가 6 에대해서는두재료의경우모두링부위응력이항복강도를넘지않았다. 그러나고정장치의벌어진각도가 10 인경우링부위의최대응력이두재료의항복강도를넘는것으로나타났다. Fig. 4-9는고정장치의 1번째, 3번째, 5번째웨지가대퇴골터널과접촉하는양상및대퇴골터널벽에발생하는응력분포를보여준다. Fig. 4-9에서가로축은대퇴골터널과고정장치웨지가접촉하기시작하는부위를원점으로하고전체둘레의길이를 1로정규화하여나타내었다. Table 2는 Fig. 4-9에서얻은대퇴골터널벽에서발생하는최대응력값을정리한것이다. 벌어진각도가 6 에서최대응력은다섯번째웨지에서발생하였으며, 10 에서는첫번째웨지에서발생하였다. 본논문에서는고정장치웨지와접촉하는대퇴터널의응력이 1MPa 이하인지점에서고정장치와대퇴터널벽과의접촉을잃는것으로간주하였다. Fig 는 Fig. 4-9로부터고정장치의첫번째, 세번째, 다섯번째웨지와대퇴터널과의접촉부위응력이 1MPa 이하로나타나기시작하는점을정규화된거리로나타낸것이다. Fig. 4-9와 Fig 로부터각재료에서벌어진각도가 6 인경우웨지번호가증가할수록웨지와접촉하는대퇴터널응력의최대값과접촉길이가증가하였다. 응력최대값과접촉길이는 CoCr 합금이약간더큰것으로나타났다. 그러나벌어진각도가 10 인경우웨지가아래로내려갈수록접촉응력과접촉길이가줄어들었다. 특히, 다섯번째웨지의경우고정장치와대퇴터널벽과의접촉길이가급격하게줄어들었다. 또한 6 의경우와는달리 316L 스테인리 스강이접촉길이가약간크게나타났다. 따라서고정장치의설계변수인벌어진각도 θ와재료의선정에따라다섯개웨지모두가고정안정성에제역할하지못할수도있을 Fig. 10 Contact length between the first wedge and bone tunnel wall Fig. 11 Contact length between the third wedge and bone tunnel wall Table 2 Maximum Mises stresses on the bone tunnel wall(mpa) θ Materials CoCr alloy L stainless steel Fig. 12 Contact length between the fifth wedge and bone tunnel wall 325

6 김종대 김홍건 Fig. 13 Migrations as according to the pull-out force applied to the fixation device 것으로생각된다. 이와같은결과는재료의탄성계수의차이에기인한것으로여겨진다. 탄성계수가보다큰 CoCr 합금이링부위의탄성력을크게만들어보다강하게접촉하므로써접촉력및접촉길이가보다크게나타나는것으로판단된다. 고정장치의벌어진각도와재료의특성이시술후초기안정성에미치는영향을살펴보기위해 pull-out force인 500N을적용하여미세이동변위를모의실험을통하여살펴보았다. Fig. 13은 pull-out 모의시험을통해구한미세이동변위를보여준다. Fig. 13에서같이벌어진각도가커짐에따라고정장치의미세이동변위가증가함을알수있다. 또한 CoCr 합금의경우가 316L 스테인리스강에비해미세이동변위가약간작음을알수있다. 이같이벌어진각도가커질수록미세이동변위가증가한것은각도가 6 인경우다섯번째웨지도뼈와접촉을유지하여 pull-out force에저항하였으나, 10 인경우다섯번째웨지와뼈는상대적으로적은양이접촉되어 (Fig. 12) pull-out force에충분히저항하지못한것으로판단된다. 또한 CoCr 합금의고정장치미세이동변위가상대적으로더작은것은고정장치의접촉형태에서와같이 CoCr 합금의탄성계수가 316L 스테인리스강보다높아접촉력이더큰것에기인한것으로생각된다. 5. 결론 본논문에서는자가확장형전방십자인대고정장치의링부위두께가 1.0mm인경우에대해, 벌어진각도가 6 와 10 인경우그리고재료가 CoCr 합금, 316L 스테인리스강인 경우고정장치의대퇴터널과의접촉양상및초기고정안정성에미치는영향을유한요소해석을통해살펴보았다. 이를위해고정장치와대퇴골터널의 3차원유한요소모델을개발하였다. 고정장치를움켜쥐었을때링부위최대응력을파악하기위한해석에서각도가 6 일때각재료의항복응력이하의응력이발생됨을알수있었다. 고정장치의웨지가대퇴골터널에접촉하였을때터널벽에발생하는응력분포의해석을통해벌어진각도변화가접촉양상을크게변화시킬수있음을알수있었다. 또한재활훈련시요구되는 500N의 pull-out force 적용에따른미세이동변위해석을통해고정장치재료의물성과설계변수값의변화에따라다섯개웨지모두가시술후초기안정성에제역할하지못할수도있음을알수있었다. 따라서자가확장형인대고정장치설계시탄성계수가보다큰재료를이용하고모든웨지에서뼈와일정한접촉을유지하도록고정장치를설계하는것이시술후초기안정성에바람직할것임을보여주었다. 참고문헌 (1) Hefti, F. L., Kress, A., Fasel, J., and Morscher, E. W., 1992, Healing of the Transected Anterior Cruciate Ligament in the Rabbit, Journal of bone and joint surgery, Vol. 73-A, No. 3, pp. 373~383. (2) Aglietti, P., Buzzi, R., Zaccherotti G., and De Biase, D. P., 1994, Patellar tendon versus doubled semitendinosus and gracilis tendons for anterior cruciate ligament reconstruction, The American Journal of Sports Medicine, Vol. 22, No. 2, pp. 211~218. (3) Brand, J., Weiler, A., Caborn, D. N., Brown, C. H. Jr., and Johnson, D. L., 2000, Graft Fixation in Cruciate Ligament Reconstruction, The American Journal of Sports Medicine, Vol. 28, No. 5, pp. 761~774. (4) A. Weiler, Hoffmann, R. F. G., Bail, H. J., Rehm, O., and Südkamp, N. P., 2002, Tendon healing in a bone tunnel: Part II: Histological analysis after biodegradable interference fit fixation in a model of anterior cruciate ligament reconstruction, Arthroscopy: The Journal of Arthroscopic & Related Surgery, Vol. 18, No. 2, pp. 124~125. (5) Robbe, R. and Paletta, G. A. Jr., 2004, Soft-Tissue Graft in Anterior Cruciate Ligament Reconstruction, 326

7 한국공작기계학회지 Vol.18 No Operative Techniques in Sports Medicine, Vol. 12, No. 4, pp. 188~194. (6) Shelbourne, K. D. and Nitz, P., 1990, Accerated rehabilitation after anterior cruciate ligament reconstruction, The American Journal of Sports Medicine, Vol. 18, No. 3, pp. 292~299. (7) Magen, H. E., Howell, S. M., and Hull, M. L., 1999, Structural properties of six tibial fixation methods for anterior cruciate ligament soft tissue grafts, The American Journal of Sports Medicine, Vol. 27, No. 1, pp. 35~43. (8) Park, J. S., Seo, T. I., Bae, J. S., and Yoon, G. S., 2006, Development and Evaluation for the Micro- Movement Structure of Interspinous, The Korea Society of Machine Tool Engineers, Vol. 15, No. 3, pp. 127~132. (9) Kim, J. D., Oh, C. Y., and Kim, C. S., 2008, The influence on the contact condition and initial fixation stability of the main design parameters of a selfexpansion type anterior cruciate ligament fixation device, Journal of Mechanical Science and Technology, Vol. 22, No. 12, pp. 2301~2309. (10) Park, J. B. and Bronzino, J. D., 2003, Biomaterials : Principles and applications, CRC Press, Boca Raton, pp. 1~9. (11) Pacific Research Labs, Vashon Island, WA, 2006, Third generation composite femur, < tecno.ior.it/vrlab/researchers/repository/bel_rep ository,html#std2_3>. (12) Kayabasi, O. and Erzincanli, F., 2006, Finite element modelling and analysis of a new cemented hip prosthesis, Advances in engineering software, Vol. 37, No. 7, pp. 477~483. (13) Song, J., Gelin, J. C., Barriere, T., and Liu, B., 2006, Experiments and numerical modelling of solid state sintering for 316L stainless steel components, Journal of materials processing technology, Vol. 177, No. 1/3, pp. 352~355. (14) Norman, T. L., Thyagarajan, G., Saligrama, V. C., Gruen T. A., and Blaha, J. D., 2001, Stem surface roughness alters creep induced subsidence and taper-lock in a cemented femoral hip prothesis, Journal of Biomechanics, Vol. 34, No. 10, pp. 1325~1333. (15) Zhong, Z. C., Wei, S. H., Wang, J. P., Feng, C. K., Chen, C. S., and Yu, C. H., Finite element analysis of the lumber spine with a new cage using a topology optimization method, Medical Engineering & Physics, Vol. 28, No. 1, pp. 90~

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