A meta-analysis of repair materials used in cranioplasty

doi:10.3969/j.issn.2095-4344.0938

Abstract

Abstract:

BACKGROUND: With the development of tissue engineering technology, there are an increasing number of materials available for cranioplasty. However, there is still a lack of higher evidence-based research to explore the difference in postoperative complications of common materials.

OBJECTIVE: To compare adverse events after cranioplasty with four commonly used materials and to present a review for the newest methods and materials for skull repair.

METHODS: Relevant literatures published from January 2012 to August 2017 were extensively reviewed. We included and analyzed retrospective studies and randomized controlled trials concerning adverse events after repair with four commonly used materials, included concerning four commonly used materials, including polymethyl methacrylate (PMMA), polyether-ether-ketone (PEEK), custom-made/ intraoperative titanium mesh, and autologous bone.

RESULTS AND CONCLUSION: Eleven eligible papers from published literatures were enrolled, containing 2 191 surgical procedures involving the four materials mentioned above. According to the outcome of Meta-analysis, postoperative complications resulting from synthetic materials are significantly less than that of autologous bone (odds ratio (OR)=0.336, 95% confidence interval (CI): 0.151-0.784, P=0.008). The higher absorption of autologous bone compared with PMMA (OR=0.034, 95% CI: 0.002-0.624, P=0.023) often results in a second surgery. Intraoperative titanium mesh that causes a high rate of exposure has been gradually replaced by custom-made titanium mesh. PMMA, PEEK and custom-made titanium mesh have no statistical difference in postoperative complications. Moreover, these three kinds of artificial materials can induce less complications compared with the autologous bone that has limited use due to a high risk of absorption and limited sources. Intraoperative titanium mesh has been gradually eliminated due to the high exposure rate. Generally, the autologous bone is not the first choice for the cranioplasty, and artificial materials mentioned above can be used in combination with price and surgeon’s habits.

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: Tissue Engineering, Skull, Postoperative Complications

CLC Number:

R318

Chen Zhi-qian, Mu Xiong-zheng. A meta-analysis of repair materials used in cranioplasty[J]. Chinese Journal of Tissue Engineering Research, 2018, 22(30): 4913-4920.

Figures/Tables 13

2.3.2 预制钛网和自体骨术后不良反应比较术后感染：共有3个研究报告了预制钛网与自体骨术后感染的情况(图3)[13-14，21]，各研究间无明显异质性(P=0.631，I2=0.0%)，采用固定效应模型分析；Meta分析结果显示：定制3D钛网和自体骨修补颅骨术后感染发生情况差异无显著性意义(OR=0.751，95%CI：0.343-1.647，P=0.475)。术后癫痫：共3个研究报告了预制钛网和自体骨术后癫痫发作的情况(图4)[13-14，21]，各研究间无明显异质性(P=0.495，I2=0.0%)，采用固定效应模型分析；Meta分析结果显示：定制3D钛网和自体骨修补颅骨术后癫痫发生的差异无显著性意义(OR=0.929，95%CI：0.318-2.712，P= 0.892)。术后外观缺陷：共3个研究报告了预制钛网和自体骨术后癫痫发作的情况(图5)[13-14，21]，各研究间存在异质性(P=0.013，I2=77.2%)，采用随机效应模型分析；Meta分析结果显示：定制3D钛网和自体骨修补颅骨术后外观缺陷发生的差异无显著性意义(OR=0.217，95%CI：0.011- 4.337，P=0.317)。 2.3.3 PMMA和自体骨术后不良反应比较术后感染：共4个研究报告了PMMA和自体骨术后癫痫发作的情况(图6)[1，16，18，22]，各研究间无明显异质性(P=0.955，I2=0.0%)，采用固定效应模型分析；Meta分析结果显示：PMMA和自体骨修补颅骨术后感染发生的差异无显著性意义(OR=0.885，95%CI：0.446-1.757，P=0.727)。术后血肿(包括硬膜外血肿、硬膜下血肿、颅内血肿)：共4个研究报告了PMMA和自体骨术后血肿发生的情况(图7)[1，16，18，22]，各研究间无明显异质性(P=0.206，I2=34.3%)，采用固定效应模型分析；Meta分析结果显示：PMMA和自体骨修补颅骨术后血肿发生的差异无显著性意义(OR=1.189，95%CI：0.563-2.512，P=0.650)。术后骨吸收：共3个研究报告了PMMA和自体骨术后骨吸收的情况(图8)[16，18，22]，各研究间存在异质性(P=0.055，I2=65.6%)，采用随机效应模型分析；Meta分析结果显示：PMMA和自体骨修补颅骨术后骨吸收发生的差异有显著性意义(OR=0.034，95%CI：0.002-0.624，P=0.023)；结果提示自体骨术后吸收率较高。术后移植物移位或愈合不佳：共4个研究报告了PMMA和自体骨术后移植物移位或者愈合不佳的情况(图9)[1，16，18，22]，各研究间无明显异质性(P=0.298，I2=18.4%)，采用固定效应模型分析；Meta分析结果显示：PMMA和自体骨修补颅骨术后血肿发生的差异无显著性意义(OR=0.471，95%CI：0.144-1.536，P=0.212)。 2.3.4 PEEK和自体骨术后不良反应 3个研究报道了PEEK与自体骨术后不良反应的比较(包括感染、骨吸收、材料暴露等不良反应)(图10)[15，19-20]；各研究间存在异质性(P=0.090，I2=58.5%)，故采用随机效应模型分析；Meta分析结果显示：PEEK和自体骨修补颅骨缺损术后不良反应的发生的差异无显著性意义(OR=0.591，95%CI：0.077-4.566，P=0.614)。 2.3.5 术中塑形钛网和PEEK术后不良反应比较共2个研究报道了术中塑形钛网与PEEK术后材料暴露的比较(图11)[15，17]；各研究间无明显异质性(P=0.249，I2=24.7%)，故采用固定效应模型分析；Meta分析结果显示：PEEK和自体骨修补颅骨缺损术后(材料暴露)的发生差异无显著性意义(OR=4.196，95%CI：0.460-38.313，P=0.204)。虽然结果提示无显著性意义，但是仔细分析数据发现两组的PEEK组均无材料暴露，而两组的术中塑形钛网材料暴露率分别为40.00%和5.96%，说明术中塑形钛网由于难以完全与颅骨贴合，暴露率较高。 2.3.6 对森林图的解读 OR为比值比，图中菱形表示合并后比值比区间，若其与OR=1相交，则两组之间差异无显著性意义；若在OR=1的左侧，表示实验组比对照组并发症少；反之，则结论相反。 2.4 发表偏倚分析总体发表偏倚漏斗图见图12，所纳入研究较为集中于漏斗图顶端，且较为对称，可见该系统评价质量总体较高，发表偏倚较小。"

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