F形空心螺钉内固定术治疗股骨颈骨折有效性和安全性的Meta分析

Clinical outcomes and safety of F-shaped hollow screw internal fixation for treatment of femoral neck fracture:a meta-analysis

目的:系统评价F形空心螺钉内固定术治疗股骨颈骨折(femoral neck fracture,FNF)的有效性和安全性。方法:检索中国知网、万方数据库、维普网、中国生物医学文献服务系统、PubMed、Cochrane Library、Embase、Web of Science中比较F形空心螺钉内固定术(F形固定组)与3枚空心螺钉平行内固定术(平行固定组)治疗FNF有效性和安全性的随机对照试验和非随机对照试验,检索时限均为2011年1月1日至2024年5月1日。由2名研究人员独立筛选文献、提取数据并评价纳入研究的偏倚风险后,采用Stata16.0软件进行Meta分析。结果:共纳入11项研究,其中非随机对照试验7项、随机对照试验4项;共涉及846例患者,其中F形固定组425例、平行固定组421例。Meta分析结果显示,与平行固定组相比,F形固定组住院时间更短[MD=-2.45,95%CI(-3.42,-1.47),P=0.000]、复位满意率更高[OR=3.49,95%CI(1.88,6.48),P=0.000]、骨折愈合更快[MD=-0.72,95%CI(-0.93,-0.50),P=0.000]、末次随访髋部疼痛视觉模拟量表评分更低[MD=-2.07,95%CI(-2.39,-1.74),P=0.000]、末次随访Harris评分更高[MD=7.62,95%CI(3.52,11.71),P=0.000]、股骨头坏死发生率更低[OR=0.32,95%CI(0.17,0.61),P=0.001]、骨折不愈合发生率更低[OR=0.42,95%CI(0.23,0.78),P=0.006]、股骨颈短缩发生率更低[OR=0.40,95%CI(0.23,0.69),P=0.001]、内固定失效发生率更低[OR=0.25,95%CI(0.13,0.51),P=0.000];2组手术时间、术中出血量、术中X线透视时间的差异均无统计学意义。分别采用固定效应模型和随机效应模型对上述结局指标进行Meta分析,所得结果基本相似,表明研究结果稳健可靠。基于末次随访Harris评分进行发表偏倚分析,Egger’s检验结果提示不存在发表偏倚(P=0.114)。结论:现有证据表明,相较于传统的3枚空心螺钉平行内固定术,采用F形空心螺钉内固定术治疗FNF临床疗效更好、安全性更高,且不会增加手术操作难度,也不会对患者造成额外创伤。

Objective:To systematically review the clinical outcomes and safety of F-shaped hollow screw internal fixation in treatment of femoral neck fracture(FNF).Methods:All the randomized controlled trial(RCT)and non-RCT articles about the clinical outcomes and safety of F-shaped hollow screw internal fixation(F-shaped fixation group)versus three hollow screws parallel internal fixation(parallel fixation group)for treatment of FNF included from January 1,2011 to May 1,2024 were retrieved from the China National Knowledge Infrastructure,Wanfang Database,Vip Database,Chinese Biomedical Literature Service System,PubMed,Cochrane Library,Embase and Web of Science.The pertinent articles were screened,the information was extracted and the risk of bias of the included researches was assessed independently by two researchers,and then a Meta-analysis was conducted by using Stata16.0 software.Results:Eleven articles(846 patients)were included in the final analysis,including 7 non-RCT articles,and 4 RCT articles.Four hundred and twenty-five patients in F-shaped fixation group,and 421 ones in parallel fixation group.The results of Meta-analysis revealed that the hospital stay was shorter,the reduction satisfaction rate and the Harris score measured at the last follow-up were higher,the fracture healing was faster,the hip pain visual analogue scale(VAS)score measured at the last follow-up and the incidence rates of femur head necrosis(FHN),fracture nonunion,femoral neck shortening and failed internal fixation were lower in F-shaped fixation group compared to parallel fixation group(MD=-2.45,95%CI(-3.42,-1.47),P=0.000;OR=3.49,95%CI(1.88,6.48),P=0.000;MD=7.62,95%CI(3.52,11.71),P=0.000;MD=-0.72,95%CI(-0.93,-0.50),P=0.000;MD=-2.07,95%CI(-2.39,-1.74),P=0.000;OR=0.32,95%CI(0.17,0.61),P=0.001;OR=0.42,95%CI(0.23,0.78),P=0.006;OR=0.40,95%CI(0.23,0.69),P=0.001;OR=0.25,95%CI(0.13,0.51),P=0.000);while,the differences in operative time,intraoperative blood loss,and intraoperative X-ray exposure were not statistically significant between the 2 groups.A re-evaluation was further performed on the aforementioned outcome indicators by employing a fixed-effect model and a random-effect model,respectively,and the results showcased that no evident change was found in the result of each outcome indicator,suggesting the results of the Meta-analysis in this study were relatively stable and reliable.Moreover,the publication bias was analyzed based on the Harris score measured at the last follow-up,and the result of Bgger’s test showed that there was no publication bias in the included articles(P=0.114).Conclusion:Available evidences suggest that,compared to the traditional parallel internal fixation with three hollow screws,the F-shaped hollow screw internal fixation behaves better in clinical outcomes and safety in the treatment of FNF,without increasing the difficulty of surgical operation or causing additional trauma to the patients.