Application of degradable implants in fracture fixation

doi:10.3969/j.issn.2095-4344.0638

Abstract

Abstract:

BACKGROUND: Degradable implants have good biocompatibility and bone conductivity, which have been gradually applied in surgical craniofacial reconstruction, anterior cruciate ligament reconstruction, meniscus repair, ankle joint fracture treatment, tibia and fibula fracture treatment.

OBJECTIVE: To summarize advantages and disadvantages of degradable implants and put forward our own opinions by comparing degradable and non-degradable implants in orthopedic fractures.

METHODS: CNKI, WanFang and Web of Science databases were retrieved for relevant articles on the application of biodegradable implants in orthopedics published from 1960 to 2017. The keywords were “biodegradable screw, biodegradable plate, orthopedics, fractures” in Chinese and English, respectively. Finally, 65 eligible articles were included in result analysis.

RESULTS AND CONCLUSION: Both magnesium alloy and polylactic acid implants have good therapeutic effects in the treatment of orthopedic fractures. However, degradable implants have their own drawbacks. Too fast degradation of the screws will lead to the rapid loss of initial strength. How to control the degradation rate of degradable screws to match the bone growth rate is still an urgent problem to be solved. Therefore, future investigations on how to slow down the degradation rate, enhance anti-wear resistance and develop degradable implants with non-toxicity and carrying multi nutrient elements are warranted.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Absorbable Implants, Fractures, Bone, Tissue Engineering

CLC Number:

R318

Li Junwei, Du Chengfei, Yuchi Chenxi, Zhang Chunqiu. Application of degradable implants in fracture fixation[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(34): 5526-5533.

Figures/Tables 9

内消旋乳酸：采用内消旋乳酸与DL-聚乳酸螺钉、接骨板治疗下颌骨骨折，均可在满足生物力学的原则上促进骨愈合，然而DL-聚乳酸的结晶度高，降解时间长，容易引发异物反应；内消旋乳酸的亲水性较好，具有较高的机械强度，降低了降解时间，提高了骨折固定的安全性。此外，采用内消旋乳酸固定的下颌骨，术后8周新生骨小梁已将骨折断面之间的缝隙充满[13]。采用内消旋乳酸植入物进行固定下颌骨骨折，能够提供与钛螺钉固定下颌骨同等的固定强度，术后患者恢复良好[14-15]。此外，临床也报道了采用内消旋乳酸板和螺钉对281例面部骨折患者进行治疗，术后16例患者产生并发症，总体治疗效果良好[16]。Tiihonen等[17]尝试采用内消旋乳酸植入物对软组织缺陷及骨质缺损患者进行治疗，虽然内消旋乳酸植入物能够为患者减轻疼痛，但不能使患者恢复到术前状态，术后患者恢复效果较差，因而对于患有软组织缺陷及骨质缺损患者不宜采用内消旋乳酸植入物进行治疗。左旋聚乳酸：1966年左旋聚乳酸缝合线第1次作为内植入物应用到动物体内，发现左旋聚乳酸缝合线无毒且可逐渐降解[18]。Eppley等[19]回顾性分析了采用左旋聚乳酸-聚乙交酯植入物进行颅面重建患者的临床疗效，术后植入物对患处起到稳定的固定，在降解过程中引发的异物反应很低，患者恢复良好，见图1。对于前交叉韧带损伤患者，由于软骨组织、滑膜及关节腔内韧带分泌的基质金属蛋白酶变化促进了关节液中基质金属蛋白酶2的升高，阻碍了前交叉韧带自身愈合[20]。前交叉韧带损伤，一旦未及时治疗可能导致膝关节过早退变[21]。动物实验表明，采用左旋聚乳酸/羟基磷灰石/α-Fe2O3与左旋聚乳酸-聚乙二醇/羟基磷灰石螺钉进行前交叉韧带重建，未出现移植物断裂及固定装置失效，提供了足够的力学性能[22]。前交叉韧带重建后骨隧道扩大会导致手术的复杂化。Arama等[23]分别采用左旋聚乳酸-羟基磷灰石螺钉与钛螺钉进行前交叉韧带重建，术后二者提供的力学性能无统计学差异，但采用左旋聚乳酸-羟基磷灰石螺钉治疗的患者，不仅降低了手术并发症发生概率，而且未引起骨隧道扩大。Robinson等[24]进一步证明采用左旋聚乳酸-羟基磷灰石螺钉进行前交叉韧带重建，能有效地降低骨隧道扩大发生的概率。此外，前交叉韧带重建过程中最薄弱的一个环节，为移植物在胫骨处的固定。采用左旋聚乳酸-羟基磷灰石螺钉对移植物进行固定，术后螺钉对移植物起到了稳定固定作用[25]。踝关节由距骨、胫骨下端和腓骨下端组成，其损伤在骨科非常常见，每年10万骨折患者中约有187例为踝关节骨折[26]。Rangdal等[27]对采用左旋聚乳酸螺钉治疗踝关节骨折患者进行随访，术后14周1例患者出现局部疼痛和肿胀，服用抗生素后并无大碍，其余患者恢复良好。临床也报道了采用左旋聚乳酸螺钉修复半月板损伤，可有效降低神经血管损伤风险[28]。通过前路减压和左旋聚乳酸螺钉进行骨移植固定可有效治疗颈椎病，术后植入物与相邻椎骨融合良好，螺钉按预期的时间降解且并发症较少[29]。Wendelstein等[30]对34例采用左旋聚乳酸螺钉矫正小脚趾畸形患者进行了为期3年的随访，术后84.6%的患者愈合良好，3例患者术后出现脚趾排列不齐，2例患者畸形复发。"

2.1.2 镁合金植入物镁合金作为骨科内植入物具有如下优点：镁是人体内必需的元素(含量21-25 g)，约53%在骨骼中，27%在肌肉，19%在软组织，0.5%在红细胞，0.3%在血清；镁可促进新骨形成及骨组织的代谢；镁的弹性模量接近于人骨，避免了应力遮挡效应；镁合金在体内具有良好的生物相容性、骨传导性和可降解特性，其可降解特性避免了二次手术取出内植入物；镁在自然界的含量较丰富。因而镁合金植入物常被用于治疗骨折患者。常用的镁合金植入物材料主要为高纯度镁合金、MgCa0.8合金、MgYREZr合金及AZ系列镁合金等。高纯度镁合金：高纯度镁合金避免了第二相杂质所产生的微电偶腐蚀，因而具有无毒、低降解率等优点。浸渍实验、细胞毒性及生物活性测试表明，高纯度镁螺钉在体外表现出均匀腐蚀行为，可提高细胞活性、骨组织的碱性磷酸酶活性及与成骨分化相关基因(如碱性磷酸酶、骨桥蛋白、人骨髓间充质干细胞RUNX2等信使核糖核酸)的表达[34]。动物体内实验表明，高纯度镁螺钉显示出了良好的骨整合性能，增加了骨量和骨密度，不但不会影响骨折部位的愈合，而且可促进新骨形成[34-37]，使骨折愈合之后达到和正常骨接近的抗弯性能[36]。高纯度镁还能通过刺激骨形成蛋白2和血管内皮生长因子的表达，促进前交叉韧带重建[38]。此外，临床上也报道了高纯度镁螺钉固定后的带血管蒂骨移植，可明显改善骨股头坏死患者髋关节功能，降低骨瓣产生位移的概率[39]。 MgCa0.8合金：将MgCa0.8螺钉植入兔胫骨，术后螺钉在体内表现出良好的耐受性以及生物相容性，但其降解速率过快，可能导致其力学性能不足(图2)[40]。Thomann等[41]将采用MgF2进行表面涂层处理的MgCa0.8植入到新西兰白兔胫骨骨髓腔，术后植入物在兔体内耐受性良好且能有效减缓其降解速率，与未涂层植入物相比，6个月后涂层植入物的强度高于未涂层植入物的强度。此外，Adam等[42]通过动物实验进一步证明MgCa0.8作为内植入物应用到动物体内无毒性。"

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