可降解高纯镁骨钉在体降解分析
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摘要
目的通过动物实验研究两种高纯镁骨钉的在体降解速率,为高纯镁骨钉的结构设计提供建议。方法将有、无螺纹的高纯镁骨钉分别植入新西兰大白兔左、右侧股骨髁处。24只实验兔随机分为3组,分别在术后8、12、16周被执行安乐死。通过micro-CT扫描及Skyscan CT-analyser软件分析,比较两种不同形状骨钉的在体降解速率,并分析骨钉降解过程中的应力变化。结果有螺纹骨钉的初始表面积[(31.70±0.06) mm~2]显著大于无螺纹骨钉的初始表面积[(29.56±0.22) mm~2]。两种高纯镁骨钉植入8、12、16周后,有螺纹骨钉的降解体积比依次为(26.01±3.44)%、(33.35±5.05)%、(36.84±6.99)%,无螺纹骨钉的降解体积比依次为(22.53±4.78)%、(31.12±6.59)%、(43.22±9.31)%,在相同时间点,两种骨钉的降解体积比之间不存在明显差异。在骨钉植入的16周内,无螺纹骨钉的降解体积与植入时间呈线性关系,有螺纹骨钉的降解体积随植入时间的增加逐渐减小。结论在低承力环境下,高纯镁骨钉的不同形状设计对其在体降解速率的影响不明显。
Objective To compare the in vivo degradation rates of two different kinds of high purity magnesium bone screws by animal experiments, so as to make some suggestions on structural design of high purity magnesium bone screws. Methods High purity magnesium bone screws with threads and without threads were implanted into femoral condyles of New Zealand rabbits separately. Twenty-four rabbits were randomly divided into 3 groups. They were euthanized at 8, 12 and 16 weeks after operation, respectively. The in vivo degradation rates of bone screws with two different shapes were compared through micro-CT scanning and Skyscan CT-analyser software, and the stress changes during the progress of bone screw degradation were analyzed. Results The initial surface area of threaded screws [(31.70±0.06) mm~2] was significantly greater than that of the non-threaded ones [(29.56±0.22) mm~2]. After 8, 12 and 16 weeks, the volume loss ratios of the threaded screws were(26.01±3.44)%,(33.35±5.05)%,(36.84±6.99)%, respectively, and the volume loss ratios of the non-threaded screws were(22.53±4.78)%,(31.12±6.59)%,(43.22±9.31)%, respectively. At the same time point, there were no significant differences in the volume loss ratio between two kinds of screws. The relationship between the volume reduction and the implantation time was linear for non-threaded screws and gradually decreasing for threaded screws. Conclusions Under the low-bearing condition, different structural design for high purity magnesium screws has no obvious effect on their degradation rate in vivo.
Objective To compare the in vivo degradation rates of two different kinds of high purity magnesium bone screws by animal experiments, so as to make some suggestions on structural design of high purity magnesium bone screws. Methods High purity magnesium bone screws with threads and without threads were implanted into femoral condyles of New Zealand rabbits separately. Twenty-four rabbits were randomly divided into 3 groups. They were euthanized at 8, 12 and 16 weeks after operation, respectively. The in vivo degradation rates of bone screws with two different shapes were compared through micro-CT scanning and Skyscan CT-analyser software, and the stress changes during the progress of bone screw degradation were analyzed. Results The initial surface area of threaded screws [(31.70±0.06) mm~2] was significantly greater than that of the non-threaded ones [(29.56±0.22) mm~2]. After 8, 12 and 16 weeks, the volume loss ratios of the threaded screws were(26.01±3.44)%,(33.35±5.05)%,(36.84±6.99)%, respectively, and the volume loss ratios of the non-threaded screws were(22.53±4.78)%,(31.12±6.59)%,(43.22±9.31)%, respectively. At the same time point, there were no significant differences in the volume loss ratio between two kinds of screws. The relationship between the volume reduction and the implantation time was linear for non-threaded screws and gradually decreasing for threaded screws. Conclusions Under the low-bearing condition, different structural design for high purity magnesium screws has no obvious effect on their degradation rate in vivo.
引文
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[11] ISHIKAWA A, TAMURA J, AKAHORI T, et al. Biodegradation of pure magnesium and bone tissue reaction in rabbit femur 1 year results of 3D micro-CT monitoring and histological observation [J]. Mater Trans, 2017, 58(1): 118-122.
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[13] 邱贵兴. 骨科植入物在临床上的应用及其不良反应事件 [J]. 中国医疗器械信息, 2006, 12(7): 1-3.
[14] GUAN H, STADEN RCV, JOHNSON NW, et al. Dynamic modelling and simulation of dental implant insertion process-A finite element study [J]. Finite Elem Anal Des, 2011, 47(8): 886-897.
[15] FRANKLYN M, FIELD B. Experimental and finite element analysis of tibial stress fractures using a rabbit model [J]. World J Orthop, 2013, 4(4): 267-278.
[16] GROVER DM, CHEN AA, HAZELWOOD SJ. Biomechanics of the rabbit knee and ankle: Muscle, ligament, and joint contact force predictions [J]. J Biomech, 2007, 40(12): 2816-2821.
[17] ZENG R, DIETZEL W, WITTE F, et al. Progress and challenge for magnesium alloys as biomaterials [J]. Adv Eng Mater, 2008, 10(8): B3-B14.
[18] SCHINHAMMER M, HOFSTETTER J, WEGMANN C, et al. On the immersion testing of degradable implant materials in simulated body fluid: active pH regulation using CO2 [J]. Adv Eng Mater, 2013, 15(6): 434-441.
[19] KOO Y, LEE HB, DONG Z, et al. The effects of static and dynamic loading on biodegradable magnesium pins in vitro and in vivo [J]. Sci Rep, 2017, 7(14710):1-9.
[20] SANCHEZ AHM, LUTHRINGER BJC, FEYERABEND F, et al. Mg and Mg alloys: How comparable are in vitro and in vivo corrosion rates? A review [J]. Acta Biomater, 2015, 13: 16-31.
[21] SONG G. Control of biodegradation of biocompatable magnesium alloys [J]. Corros Sci, 2007, 49(4): 1696-1701.
[22] WANG H, SHI Z. In vitro biodegradation behavior of magnesium and magnesium alloy [J]. J Biomed Mater Res, 2011, 98B(2): 203-209.
[23] CHAYA A, YOSHIZAWA S, VERDELIS K, et al. In vivo study of magnesium plate and screw degradation and bone fracture healing [J]. Acta Biomater, 2015, 18: 262-269.
[24] ZHAO D, HUANG S, LU F, et al. Vascularized bone grafting fixed by biodegradable magnesium screw for treating osteonecrosis of the femoral head [J]. Biomaterials, 2016, 81: 84-92.
[25] 漆伟, 雷伟, 严亚波. 椎弓根螺钉长度变化对螺钉-骨复合体模型应力影响的三维有限元分析研究 [J]. 医用生物力学, 2010, 25(3): 206-211.QI W, LEI W, YAN YB. Three dimensional finite element analysis of stress distribution on continuously varying of length of pedicle screw [J]. J Med Biomech, 2010, 25(3): 206-211.
[26] TSUANG FY, CHEN CH, WU LC, et al. Biomechanical arrangement of threaded and unthreaded portions providing holding power of transpedicular screw fixation [J]. Clin Biomech, 2016, 39: 71-76.
[27] GASTALDI D, SASSI V, PETRINI L, et al. Continuum damage model for bioresorbable magnesium alloy devices-Application to coronary stents [J]. J Mech Behav Biomed Mater, 2011, 4(3): 352-365.
[28] ZHENG Y, LI Y, CHEN J, et al. Effects of tensile and compressive deformation on corrosion behaviour of a Mg-Zn alloy [J]. Corros Sci, 2015, 90: 445-450.
[29] HAN P, CHENG P, ZHANG S, et al. In vitro and in vivo studies on the degradation of high-purity Mg (99.99wt.%) screw with femoral intracondylar fractured rabbit model [J]. Biomaterials, 2015, 64: 57-69.
[2] STAIGER MP, PIETAK AM, HUADMAI J, et al. Magnesium and its alloys as orthopedic biomaterials: A review [J]. Biomaterials, 2006, 27(9): 1728-1734.
[3] GALLI S, STOCCHERO M, ANDERSSON M, et al. The effect of magnesium on early osseointegration in osteoporotic bone: A histological and gene expression investigation [J]. Osteoporosis Int, 2017, 28(7): 2195-2205.
[4] WANG J, XU J, SONG B, et al. Magnesium (Mg) based interference screws developed for promoting tendon graft incorporation in bone tunnel in rabbits [J]. Acta Biomater, 2017, 63: 393-410.
[5] ZHANG Y, XU J, RUAN YC, et al. Implant-derived magnesium induces local neuronal production of CGRP to improve bone-fracture healing in rats [J]. Nat Med, 2016, 22(10): 1160-1169.
[6] 郑玉峰, 顾雪楠, 李楠, 等. 生物可降解镁合金的发展现状与展望 [J]. 中国材料进展, 2011, 30(4): 30-43.
[7] WITTE F, FISCHER J, NELLESEN J, et al. In vitro and in vivo corrosion measurements of magnesium alloys [J]. Biomaterials, 2006, 27(7): 1013-1018.
[8] SCHALLER B, SAULACIC N, IMWINKELRIED T, et al. In vivo degradation of magnesium plate/screw osteosynthesis implant systems: Soft and hard tissue response in a calvarial model in miniature pigs [J]. J Craniomaxillofac Surg, 2016, 44(3): 309-317.
[9] CHENG P, ZHAO C, HAN P, et al. Site-dependent osseointegration of biodegradable high-purity magnesium for orthopedic implants in femoral shaft and femoral condyle of New Zealand rabbits [J]. J Mater Sci Technol, 2016, 32(9): 883-888.
[10] HAN P, CHENG P, ZHAO C, et al. Comparative study about degradation of high-purity magnesium screw in intact femoral intracondyle and in fixation of femoral intracondylar fracture [J]. J Mater Sci Technol, 2017, 33(3): 305-310.
[11] ISHIKAWA A, TAMURA J, AKAHORI T, et al. Biodegradation of pure magnesium and bone tissue reaction in rabbit femur 1 year results of 3D micro-CT monitoring and histological observation [J]. Mater Trans, 2017, 58(1): 118-122.
[12] NINA VDH, BORMANN D, LUCAS A, et al. Comparison of the in vivo degradation progress of solid magnesium alloy cylinders and screw-shaped magnesium alloy cylinders in a rabbit model [J]. Mater Sci Forum, 2010, 638-642: 742-747.
[13] 邱贵兴. 骨科植入物在临床上的应用及其不良反应事件 [J]. 中国医疗器械信息, 2006, 12(7): 1-3.
[14] GUAN H, STADEN RCV, JOHNSON NW, et al. Dynamic modelling and simulation of dental implant insertion process-A finite element study [J]. Finite Elem Anal Des, 2011, 47(8): 886-897.
[15] FRANKLYN M, FIELD B. Experimental and finite element analysis of tibial stress fractures using a rabbit model [J]. World J Orthop, 2013, 4(4): 267-278.
[16] GROVER DM, CHEN AA, HAZELWOOD SJ. Biomechanics of the rabbit knee and ankle: Muscle, ligament, and joint contact force predictions [J]. J Biomech, 2007, 40(12): 2816-2821.
[17] ZENG R, DIETZEL W, WITTE F, et al. Progress and challenge for magnesium alloys as biomaterials [J]. Adv Eng Mater, 2008, 10(8): B3-B14.
[18] SCHINHAMMER M, HOFSTETTER J, WEGMANN C, et al. On the immersion testing of degradable implant materials in simulated body fluid: active pH regulation using CO2 [J]. Adv Eng Mater, 2013, 15(6): 434-441.
[19] KOO Y, LEE HB, DONG Z, et al. The effects of static and dynamic loading on biodegradable magnesium pins in vitro and in vivo [J]. Sci Rep, 2017, 7(14710):1-9.
[20] SANCHEZ AHM, LUTHRINGER BJC, FEYERABEND F, et al. Mg and Mg alloys: How comparable are in vitro and in vivo corrosion rates? A review [J]. Acta Biomater, 2015, 13: 16-31.
[21] SONG G. Control of biodegradation of biocompatable magnesium alloys [J]. Corros Sci, 2007, 49(4): 1696-1701.
[22] WANG H, SHI Z. In vitro biodegradation behavior of magnesium and magnesium alloy [J]. J Biomed Mater Res, 2011, 98B(2): 203-209.
[23] CHAYA A, YOSHIZAWA S, VERDELIS K, et al. In vivo study of magnesium plate and screw degradation and bone fracture healing [J]. Acta Biomater, 2015, 18: 262-269.
[24] ZHAO D, HUANG S, LU F, et al. Vascularized bone grafting fixed by biodegradable magnesium screw for treating osteonecrosis of the femoral head [J]. Biomaterials, 2016, 81: 84-92.
[25] 漆伟, 雷伟, 严亚波. 椎弓根螺钉长度变化对螺钉-骨复合体模型应力影响的三维有限元分析研究 [J]. 医用生物力学, 2010, 25(3): 206-211.QI W, LEI W, YAN YB. Three dimensional finite element analysis of stress distribution on continuously varying of length of pedicle screw [J]. J Med Biomech, 2010, 25(3): 206-211.
[26] TSUANG FY, CHEN CH, WU LC, et al. Biomechanical arrangement of threaded and unthreaded portions providing holding power of transpedicular screw fixation [J]. Clin Biomech, 2016, 39: 71-76.
[27] GASTALDI D, SASSI V, PETRINI L, et al. Continuum damage model for bioresorbable magnesium alloy devices-Application to coronary stents [J]. J Mech Behav Biomed Mater, 2011, 4(3): 352-365.
[28] ZHENG Y, LI Y, CHEN J, et al. Effects of tensile and compressive deformation on corrosion behaviour of a Mg-Zn alloy [J]. Corros Sci, 2015, 90: 445-450.
[29] HAN P, CHENG P, ZHANG S, et al. In vitro and in vivo studies on the degradation of high-purity Mg (99.99wt.%) screw with femoral intracondylar fractured rabbit model [J]. Biomaterials, 2015, 64: 57-69.