置入碳纤维增强聚醚醚酮股骨头假体稳定性的生物力学分析
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摘要
背景:在关节置换领域里,金属合金材料始终处于主导地位,但这种材料的最大缺陷是弹性模量高,由此产生应力遮挡,进而引起骨吸收、骨萎缩甚至假体松动等一系列并发症。碳纤维增强聚醚醚酮复合材料是各向异性材料,可以达到低弹高强,应用于制备人工假体有许多优势。目的:探讨碳纤维增强聚醚醚酮复合材料的血液相容性,并比较了碳纤维增强聚醚醚酮复合材料股骨头假体和钴铬钼合金股骨头假体置换后的生物力学特性。方法:(1)以溶血实验评价碳纤维增强聚醚醚酮复合材料的血液相容性;(2)收集8对新鲜成人尸体股骨标本,随机分为碳纤维增强聚醚醚酮假体组和钴铬钼合金假体组进行相应假体置换,测量加载200,400,600,800,1 000 N负荷下假体与骨之间的微动量,并检测假体置换后的抗扭转强度。结果与结论:(1)以碳纤维增强聚醚醚酮复合材料的溶血率为3.23%<5%,符合国家医疗器械生物学评价标准;(2)2组假体远端微动均明显小于近端(P<0.05);不同负荷下钴铬钼合金假体组远端、近端的微动量均显著大于碳纤维增强聚醚醚酮假体组(P<0.05);(3)碳纤维增强聚醚醚酮假体组不同负荷下的载荷-扭角均显著小于钴铬钼合金假体组(P<0.05),抗扭刚度均显著大于钴铬钼合金假体组(P<0.05);(4)结果说明碳纤维增强聚醚醚酮复合材料血液相容性较好,具有较好的稳定性,可用于假体置换。
BACKGROUND: Metal implants have been extensively applied in joint arthoplasty, but the stress shielding effect caused by its high elastic modulus results in a series of complications, such as bone resorption, bone atrophy and prosthesis loosening. Carbon fiber-reinforced polyetheretherketone(CF-PEEK) composites are anisotropic and exhibit more advantages used for prosthesis due to its low elastic modulus and high intensity.OBJECTIVE: To investigate the blood compatibility of CF-PEEK composites, and compare the biomechanical properties after arthroplasty between CF-PEEK composites and Co-Cr-Mo used for femoral head prosthesis. METHODS:(1) The blood compatibility of CF-PEEK composites was evaluated through hemolysis test.(2) Femoral samples from eight fresh cadavers were collected and randomly divided into two groups, followed by subjected to CF-PEEK and Co-Cr-Mo prosthesis replacement, respectively. The displacement between the prosthesis and bone was measured under loading 200, 400, 600, 800 and 1 000 N, and the torsional strength after arthroplasty was detected. RESULTS AND CONCLUSION:(1) The hemolysis rate of the CF-PEEK composites was 3.23% < 5%, which was in line with the national standards for biological evaluation of medical devices.(2) The micromovement in distal prosthesis was significantly less than that of proximal prosthesis under different loads in both two groups(P < 0.05).(3) The torsion angle under different loads in the CF-PEEK group was significantly less than that in the Co-Cr-Mo group(P < 0.05), and the torsion stiffness in the CF-PEEK group was significantly higher than that in the Co-Cr-Mo group(P < 0.05).(4) To conclude, the CF-PEEK composites possess good blood compatibility and stability, which can be used as a prosthesis material.
BACKGROUND: Metal implants have been extensively applied in joint arthoplasty, but the stress shielding effect caused by its high elastic modulus results in a series of complications, such as bone resorption, bone atrophy and prosthesis loosening. Carbon fiber-reinforced polyetheretherketone(CF-PEEK) composites are anisotropic and exhibit more advantages used for prosthesis due to its low elastic modulus and high intensity.OBJECTIVE: To investigate the blood compatibility of CF-PEEK composites, and compare the biomechanical properties after arthroplasty between CF-PEEK composites and Co-Cr-Mo used for femoral head prosthesis. METHODS:(1) The blood compatibility of CF-PEEK composites was evaluated through hemolysis test.(2) Femoral samples from eight fresh cadavers were collected and randomly divided into two groups, followed by subjected to CF-PEEK and Co-Cr-Mo prosthesis replacement, respectively. The displacement between the prosthesis and bone was measured under loading 200, 400, 600, 800 and 1 000 N, and the torsional strength after arthroplasty was detected. RESULTS AND CONCLUSION:(1) The hemolysis rate of the CF-PEEK composites was 3.23% < 5%, which was in line with the national standards for biological evaluation of medical devices.(2) The micromovement in distal prosthesis was significantly less than that of proximal prosthesis under different loads in both two groups(P < 0.05).(3) The torsion angle under different loads in the CF-PEEK group was significantly less than that in the Co-Cr-Mo group(P < 0.05), and the torsion stiffness in the CF-PEEK group was significantly higher than that in the Co-Cr-Mo group(P < 0.05).(4) To conclude, the CF-PEEK composites possess good blood compatibility and stability, which can be used as a prosthesis material.
引文
[1]俞能宝,董天华,孙俊英.复合材料股骨头假体三维有限元分析[J].医用生物力学,2001,16(3):155-159.
[2]Wallis JA,Taylor NF.Pre-operative interventions(non-surgical and non-pharmacological)for patients with hip or knee osteoarthritis awaiting joint replacement surgery--a systematic review and meta-analysis.Osteoarthritis Cartilage.2011;19(12):1381-1395.
[3]白艳杰.钛铌合金生物相容性评价与植入实验研究[D].重庆:重庆医科大学,2012.
[4]吕厚山.人工关节的新进展[J].首都医药,2001,8(4):36-38.
[5]Martin Ihle,Sabine Mai,Werner E.Siebert,等.陶瓷球头和金属球头配伍聚乙烯臼杯的20年长期对比磨损研究[J].中华关节外科杂志(电子版),2010,4(3):392-396.
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[7]彭慧明,翁习生.聚醚醚酮材料在骨科植入物的应用进展[J].中华骨科杂志,2011,31(3):265-269.
[8]贾庆卫,汤亭亭,戴克戎.碳增强聚醚醚酮人工关节假体材料的磨损性能研究[J].生物骨科材料与临床研究,2004,1(2):1-4.
[9]俞能宝,董天华,孙俊英.复合材料股骨头的假体生物力学评价[J].中国矫形外科杂志,2001,8(12):1157-1159.
[10]张正廉,孙俊英,孙康.碳纤维增强聚醚醚酮股骨头假体置换术后的即刻稳定性[J].中华创伤骨科杂志,2005,7(10):939-942.
[11]张正廉.CF/PEEK全髋股骨头假体的研制与生物力学实验研究[D].苏州:苏州大学,2004.
[12]奚廷斐.医疗器械生物学评价标准[M].北京:中国标准出版社,2012.
[13]俞能宝.复合材料全髋股骨头假体研制与生物力学实验研究[D].苏州:苏州医学院,1998.
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[16]Mahmood SS,Mukka SS,Crnalic S,et al.Association between changes in global femoral offset after total hip arthroplasty and function,quality of life,and abductor muscle strength.A prospective cohort study of 222 patients.Acta Orthop.2016;87(1):36-41.
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[18]伍骥,苏斌,吴迪,等.金属对金属人工髋关节假体需要关注的问题[J].中华关节外科杂志:电子版,2010,4(5):671-674.
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[20]Wang L,Lei P,Xie J,et al.Medium-term outcomes of cemented prostheses and cementless modular prostheses in revision total hip arthroplasty.Sci Rep.2013;3:2796.
[21]Pui CM,Bostrom MP,Westrich GH,et al.Increased complication rate following conversion total hip arthroplasty after cephalomedullary fixation for intertrochanteric hip fractures:a multi-center study.J Arthroplasty.2013;28(8 Suppl):45-47.
[22]Romagnoli S,Zacchetti S,Perazzo P,et al.Simultaneous bilateral total hip arthroplasties do not lead to higher complication or allogeneic transfusion rates compared to unilateral procedures.Int Orthop.2013;37(11):2125-2130.
[23]Sadoghi P,Liebensteiner M,Agreiter M,et al.Revision surgery after total joint arthroplasty:a complication-based analysis using worldwide arthroplasty registers.J Arthroplasty.2013;28(8):1329-1332.
[24]Langton DJ,Sprowson AP,Joyce TJ,et al.Blood metal ion concentrations after hip resurfacing arthroplasty:a comparative study of articular surface replacement and Birmingham Hip Resurfacing arthroplasties.J Bone Joint Surg Br.2009;91(10):1287-1295.
[25]曹俊奎,黄智华.聚醚醚酮分子结构对流动性和热性能的影响[J].高分子学报,1994,1(1):27-33.
[26]Kawamura T,Kurashiki T,Nakai H,et al.Study on a Stiffness Design Method of Femoral Prosthesis Stem Using Fiber Reinforced Composites.Key Eng Mater.2007;334-335:1257-1260.
[27]Murakami N,Saito N,Takahashi J,et al.Repair of a proximal femoral bone defect in dogs using a porous surfaced prosthesis in combination with recombinant BMP-2 and a synthetic polymer carrier.Biomaterials.2003;24(13):2153-2159.
[28]Brockett CL,Carbone S,Fisher J,et al.PEEK and CFR-PEEK as alternative bearing materials to UHMWPE in a fixed bearing total knee replacement:An experimental wear study.Wear.2017;374-375:86-91.
[29]Stratton-Powell AA,Pasko KM,Brockett CL,et al.The Biologic Response to Polyetheretherketone(PEEK)Wear Particles in Total Joint Replacement:A Systematic Review.Clin Orthop Relat Res.2016;474(11):2394-2404.
[30]Anguiano-Sanchez J,Martinez-Romero O,Siller HR,et al.Influence of PEEK Coating on Hip Implant Stress Shielding:A Finite Element Analysis.Comput Math Methods Med.2016;2016:6183679.
[31]Rezaei F,Hassani K,Solhjoei N,et al.Carbon/PEEK composite materials as an alternative for stainless steel/titanium hip prosthesis:a finite element study.Australas Phys Eng Sci Med.2015;38(4):569-580.
[32]Nakahara I,Takao M,Bandoh S,et al.Fixation strength of taper connection at head-neck junction in retrieved carbon fiber-reinforced PEEK hip stems.J Artif Organs.2014;17(4):358-363.
[33]Brown T,Bao QB,Agrawal CM,et al.An in vitro assessment of wear particulate generated from NUBAC:a PEEK-on-PEEK articulating nucleus replacement device:methodology and results from a series of wear tests using different motion profiles,test frequencies,and environmental conditions.Spine(Phila Pa 1976).2011;36(26):E1675-1685.
[34]Pace N,Marinelli M,Spurio S.Technical and histologic analysis of a retrieved carbon fiber-reinforced poly-ether-ether-ketone composite alumina-bearing liner 28months after implantation.J Arthroplasty.2008;23(1):151-155.
[35]贾庆卫,孙俊英,江宏卫,等.碳增强的聚醚醚酮作为髋臼假体材料的实验研究[J].中国矫形外科杂志,2003,11(3):210-213.
[36]Takatori Y,Moro T,Kamogawa M,et al.Poly(2-methacryloyloxyethyl phosphorylcholine)-grafted highly cross-linked polyethylene liner in primary total hip replacement:one-year results of a prospective cohort study.J Artif Organs.2013;16(2):170-175.
[37]Seibert R,Marcellin-Little DJ,Roe SC,et al.Comparison of body weight distribution,peak vertical force,and vertical impulse as measures of hip joint pain and efficacy of total hip replacement.Vet Surg.2012;41(4):443-447.
[38]Gossec L,Paternotte S,Maillefert JF,et al.The role of pain and functional impairment in the decision to recommend total joint replacement in hip and knee osteoarthritis:an international cross-sectional study of 1909 patients.Report of the OARSI-OMERACT Task Force on total joint replacement.Osteoarthritis Cartilage.2011;19(2):147-154.
[39]康鹏德,沈彬,裴福兴.全髋关节置换术中第二代金属-金属负重界面假体的应用[J].中华骨科杂志,2012,32(2):185-190.
[40]吴荣寰,林向进.髋关节置换后假体无菌性松动机制研究[J].国际骨科学杂志,2007,28(2):122-124.
[41]宋剑,王松,廖振华,等.聚醚醚酮及其改性的人工关节材料的摩擦磨损性能研究进展[J].功能材料,2014,45(23):23010-23015,23019.
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[46]Saidi K,Ben-Lulu O,Tsuji M,et al.Supracondylar periprosthetic fractures of the knee in the elderly patients:a comparison of treatment using allograft-implant composites,standard revision components,distal femoral replacement prosthesis.J Arthroplasty.2014;29(1):110-114.
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[50]吴欣鑫.碳纤维增强聚醚醚酮复合材料及其摩擦磨损性能研究[D].南京:南京理工大学,2012.
[2]Wallis JA,Taylor NF.Pre-operative interventions(non-surgical and non-pharmacological)for patients with hip or knee osteoarthritis awaiting joint replacement surgery--a systematic review and meta-analysis.Osteoarthritis Cartilage.2011;19(12):1381-1395.
[3]白艳杰.钛铌合金生物相容性评价与植入实验研究[D].重庆:重庆医科大学,2012.
[4]吕厚山.人工关节的新进展[J].首都医药,2001,8(4):36-38.
[5]Martin Ihle,Sabine Mai,Werner E.Siebert,等.陶瓷球头和金属球头配伍聚乙烯臼杯的20年长期对比磨损研究[J].中华关节外科杂志(电子版),2010,4(3):392-396.
[6]Zimmerma S,Hawkes WG,Hudson JI,et al.Outcomes of surgical management of total HIP replacement in patients aged 65 years and older:cemented versus cementless femoral components and lateral or anterolateral versus posterior anatomical approach.J Orthop Res.2002;20(2):182-191.
[7]彭慧明,翁习生.聚醚醚酮材料在骨科植入物的应用进展[J].中华骨科杂志,2011,31(3):265-269.
[8]贾庆卫,汤亭亭,戴克戎.碳增强聚醚醚酮人工关节假体材料的磨损性能研究[J].生物骨科材料与临床研究,2004,1(2):1-4.
[9]俞能宝,董天华,孙俊英.复合材料股骨头的假体生物力学评价[J].中国矫形外科杂志,2001,8(12):1157-1159.
[10]张正廉,孙俊英,孙康.碳纤维增强聚醚醚酮股骨头假体置换术后的即刻稳定性[J].中华创伤骨科杂志,2005,7(10):939-942.
[11]张正廉.CF/PEEK全髋股骨头假体的研制与生物力学实验研究[D].苏州:苏州大学,2004.
[12]奚廷斐.医疗器械生物学评价标准[M].北京:中国标准出版社,2012.
[13]俞能宝.复合材料全髋股骨头假体研制与生物力学实验研究[D].苏州:苏州医学院,1998.
[14]Tilbury C,Holtslag MJ,Tordoir RL,et al.Outcome of total hip arthroplasty,but not of total knee arthroplasty,is related to the preoperative radiographic severity of osteoarthritis.A prospective cohort study of 573 patients.Acta Orthop.2016;87(1):67-71.
[15]Sirka A,Clauss M,Tarasevicius S,et al.Excellent long-term results of the Müller acetabular reinforcement ring in primary total hip arthroplasty:A prospective study on radiology and survival of 321 hips with a mean follow-up of 11 years.Acta Orthop.2016;87(2):100-105.
[16]Mahmood SS,Mukka SS,Crnalic S,et al.Association between changes in global femoral offset after total hip arthroplasty and function,quality of life,and abductor muscle strength.A prospective cohort study of 222 patients.Acta Orthop.2016;87(1):36-41.
[17]Hjorth MH,Stilling M,Soballe K,et al.No association between pseudotumors,high serum metal-ion levels and metal hypersensitivity in large-head metal-on-metal total hip arthroplasty at 5-7-year follow-up.Skeletal Radiol.2016;45(1):115-125.
[18]伍骥,苏斌,吴迪,等.金属对金属人工髋关节假体需要关注的问题[J].中华关节外科杂志:电子版,2010,4(5):671-674.
[19]Mazonakis M,Berris T,Lyraraki E,et al.Cancer risk estimates from radiation therapy for heterotopic ossification prophylaxis after total hip arthroplasty.Med Phys.2013;40(10):101702.
[20]Wang L,Lei P,Xie J,et al.Medium-term outcomes of cemented prostheses and cementless modular prostheses in revision total hip arthroplasty.Sci Rep.2013;3:2796.
[21]Pui CM,Bostrom MP,Westrich GH,et al.Increased complication rate following conversion total hip arthroplasty after cephalomedullary fixation for intertrochanteric hip fractures:a multi-center study.J Arthroplasty.2013;28(8 Suppl):45-47.
[22]Romagnoli S,Zacchetti S,Perazzo P,et al.Simultaneous bilateral total hip arthroplasties do not lead to higher complication or allogeneic transfusion rates compared to unilateral procedures.Int Orthop.2013;37(11):2125-2130.
[23]Sadoghi P,Liebensteiner M,Agreiter M,et al.Revision surgery after total joint arthroplasty:a complication-based analysis using worldwide arthroplasty registers.J Arthroplasty.2013;28(8):1329-1332.
[24]Langton DJ,Sprowson AP,Joyce TJ,et al.Blood metal ion concentrations after hip resurfacing arthroplasty:a comparative study of articular surface replacement and Birmingham Hip Resurfacing arthroplasties.J Bone Joint Surg Br.2009;91(10):1287-1295.
[25]曹俊奎,黄智华.聚醚醚酮分子结构对流动性和热性能的影响[J].高分子学报,1994,1(1):27-33.
[26]Kawamura T,Kurashiki T,Nakai H,et al.Study on a Stiffness Design Method of Femoral Prosthesis Stem Using Fiber Reinforced Composites.Key Eng Mater.2007;334-335:1257-1260.
[27]Murakami N,Saito N,Takahashi J,et al.Repair of a proximal femoral bone defect in dogs using a porous surfaced prosthesis in combination with recombinant BMP-2 and a synthetic polymer carrier.Biomaterials.2003;24(13):2153-2159.
[28]Brockett CL,Carbone S,Fisher J,et al.PEEK and CFR-PEEK as alternative bearing materials to UHMWPE in a fixed bearing total knee replacement:An experimental wear study.Wear.2017;374-375:86-91.
[29]Stratton-Powell AA,Pasko KM,Brockett CL,et al.The Biologic Response to Polyetheretherketone(PEEK)Wear Particles in Total Joint Replacement:A Systematic Review.Clin Orthop Relat Res.2016;474(11):2394-2404.
[30]Anguiano-Sanchez J,Martinez-Romero O,Siller HR,et al.Influence of PEEK Coating on Hip Implant Stress Shielding:A Finite Element Analysis.Comput Math Methods Med.2016;2016:6183679.
[31]Rezaei F,Hassani K,Solhjoei N,et al.Carbon/PEEK composite materials as an alternative for stainless steel/titanium hip prosthesis:a finite element study.Australas Phys Eng Sci Med.2015;38(4):569-580.
[32]Nakahara I,Takao M,Bandoh S,et al.Fixation strength of taper connection at head-neck junction in retrieved carbon fiber-reinforced PEEK hip stems.J Artif Organs.2014;17(4):358-363.
[33]Brown T,Bao QB,Agrawal CM,et al.An in vitro assessment of wear particulate generated from NUBAC:a PEEK-on-PEEK articulating nucleus replacement device:methodology and results from a series of wear tests using different motion profiles,test frequencies,and environmental conditions.Spine(Phila Pa 1976).2011;36(26):E1675-1685.
[34]Pace N,Marinelli M,Spurio S.Technical and histologic analysis of a retrieved carbon fiber-reinforced poly-ether-ether-ketone composite alumina-bearing liner 28months after implantation.J Arthroplasty.2008;23(1):151-155.
[35]贾庆卫,孙俊英,江宏卫,等.碳增强的聚醚醚酮作为髋臼假体材料的实验研究[J].中国矫形外科杂志,2003,11(3):210-213.
[36]Takatori Y,Moro T,Kamogawa M,et al.Poly(2-methacryloyloxyethyl phosphorylcholine)-grafted highly cross-linked polyethylene liner in primary total hip replacement:one-year results of a prospective cohort study.J Artif Organs.2013;16(2):170-175.
[37]Seibert R,Marcellin-Little DJ,Roe SC,et al.Comparison of body weight distribution,peak vertical force,and vertical impulse as measures of hip joint pain and efficacy of total hip replacement.Vet Surg.2012;41(4):443-447.
[38]Gossec L,Paternotte S,Maillefert JF,et al.The role of pain and functional impairment in the decision to recommend total joint replacement in hip and knee osteoarthritis:an international cross-sectional study of 1909 patients.Report of the OARSI-OMERACT Task Force on total joint replacement.Osteoarthritis Cartilage.2011;19(2):147-154.
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