悬吊固定与交叉钉固定在重建前交叉韧带股骨侧固定方式优劣的Meta分析

Suspensory versus Cross-pin Femoral Fixation in an ACL Reconstruction:a Meta-analysis

背景膝关节前交叉韧带重建中,股骨端固定方式按照固定点和关节线的距离可将其分为远离关节面的间接悬吊固定和近关节面的交叉钉直接固定,目前对于股骨侧采用何种固定方式更加优越还没有共识。目的以Meta分析的方法评价悬吊固定和交叉钉固定在重建前交叉韧带在股骨侧固定方式的优劣。方法计算机检索中国知网(CNKI)、万方数据知识服务平台、维普网、中国生物医学文献数据库(CBM)、PubMed、EMBase、Cochrane Library等数据库,以主题词联合自由词、关键词进行综合检索,检索时间为建库至2017-12-01。选取试验组股骨侧固定方式为悬吊固定,对照组股骨侧固定方式为交叉钉固定的随机对照试验,进行文献质量评价,应用RevMan 5.3软件进行Meta分析。结果共纳入15篇文献,961例患者,其中试验组482例,对照组479例。采用英国牛津证据分级进行预评价:1b级证据7篇,2b级证据8篇。Meta分析结果显示,两组术后1年Lysholm评分、术后1年KT1000关节动度仪测量结果、术后2年KT1000关节动度仪测量结果比较,差异均无统计学意义〔均数差(MD)=-0.42,95%CI(-1.09,0.25),P=0.22;MD=-0.22,95%CI(-0.51,0.08),P=0.15;MD=0,95%CI(-0.36,0.36),P=1.00〕。两组国际膝关节文献委员会膝关节评估表(IKDC)正常级别、接近正常级别、异常级别、严重异常级别所占比例比较,差异均无统计学意义〔比值比(OR)=0.93,95%CI(0.61,1.42),P=0.73;OR=0.91,95%CI(0.60,1.38),P=0.65;OR=1.35,95%CI(0.66,2.73),P=0.41;OR=4.05,95%CI(0.44,37.70),P=0.22〕。由于各研究间测量骨道增宽的方法和统计学结果不尽相同,故采用描述性分析。在有限的证据下得出:在骨道增宽程度中,试验组高于对照组。两组并发症发生率比较,差异无统计学意义〔OR=0.80,95%CI(0.39,1.64),P=0.55〕。以术后IKDC等级为例进行漏斗图分析,结果显示纳入文献均落在漏斗图中,且两侧相对均匀分布,说明发表偏倚可能性较低。结论与交叉钉固定相比,重建前交叉韧带在股骨端使用悬吊固定对骨道增宽程度影响更大,但在术后Lysholm评分、术后KT1000关节动度仪测量结果、术后IKDC等级以及术后并发症方面,两组无差异。虽然重建前交叉韧带股骨端使用交叉钉固定能减少移植物在隧道内产生的滑移增宽,术后临床指标两者类似,临床上应综合各方面因素而选择最佳的手术方式。

Background Femoral fixation methods for an anterior cruciate ligament(ACL) reconstruction,can be divided into suspensory fixation(indirect fixation) away from the joint and cross-pin fixation(direct fixation) near the joint surface,according to the distance between the fixed point and the joint line.But there is no consensus on which fixation method is more superior.Objective To perform a comparative meta-analysis of the advantages and disadvantages of suspensory versus cross-pin femoral fixation in an ACL reconstruction.Methods We systematically retrieved the databases of CNKI,Wanfang Data Knowledge Service Platform,VIP,CBM,PubMed,EMBase and Cochrane Library for RCTs regarding ACLreconstructed patients with suspensory femoral fixation(experimental group) compared with those with cross-pin femoral fixation(control group) using subject headings combined with free words and key words as of December 1,2017.Quality assessment was conducted on eligible RCTs.Meta-analysis was performed using RevMan 5.3 software.Results A total of 15 RCTs were included,and 7 of them were initially rated as 1 b and other 8 were 2 b by the Oxford Centre for Evidence-based Medicine Levels of Evidence,involving 961 cases,of whom 482 with suspensory femoral fixation,and other 479 with cross-pin femoral fixation.Meta-analysis showed that both groups had no significant differences in Lysholm knee score at 12 months after surgery 〔MD=-0.42,95%CI(-1.09,0.25),P=0.22〕,KT1000 arthrometer measurements 〔MD=-0.22,95%CI(-0.51,0.08),P=0.15〕 at 12 months after surgery,and KT1000 arthrometer measurements 〔MD=0,95%CI(-0.36,0.36),P=1.00〕 at 24 months after surgery.Moreover,both groups also showed no significant differences in the percentages of normal,nearly normal,abnormal and severely abnormal IKDC scores 〔OR=0.93,95%CI(0.61,1.42),P=0.73;OR=0.91,95%CI(0.60,1.38),P=0.65;OR=1.35,95%CI(0.66,2.73),P=0.41;OR=4.05,95%CI(0.44,37.70),P=0.22〕.In terms of bone tunnel enlargement,descriptive analysis(this method was used due to methods for measuring bone tunnel and statistical results in the RCTs were different) found that,the experimental group had greater enlargement than the control group.And the incidence of complications was similar in both groups〔OR=0.80,95%CI(0.39,1.64),P=0.55〕.Results of postsurgical IKDC score from all studies scattered in the funnel plot,which showed a symmetrical shape,indicating the level of publication bias was low.Conclusion Suspensory and cross-pin femoral fixation have similar postsurgical outcomes evaluated by indicators such as Lysholm knee score at 12 months after surgery,KT1000 arthrometer measurements at 12 and 24 months after surgery,and IKDC scores as well as the incidence of complications,except the latter produces a greater impact on reducing bone tunnel enlargement due to the movement of graft.In view of the above-mentioned aspects,femoral fixation method should be selected based on an overall consideration of various factors.