两种PEEK界面螺钉和带袢钢板在关节镜下前交叉韧带重建的非劣效性研究

A non-inferiority study of two types of PEEK interface screws and EndoButton for anterior cruciate ligament reconstruction under arthroscopy

目的 :评估Delta Medical公司的聚醚醚酮(PEEK)界面螺钉和带袢钢板(EndoButton)与Smith&Nephew公司的PEEK界面螺钉和带袢钢板在关节镜下前交叉韧带重建患者中的临床疗效。方法 :选取2017年11月―2019年7月在湖南省人民医院(湖南师范大学附属第一医院)接受关节镜下前交叉韧带(ACL)重建术的16例ACL损伤患者,随机分为两组(观察组和对照组),每组8例。观察组术中采用德美公司的PEEK界面螺钉和带袢钢板;对照组采用施乐辉公司的PEEK界面螺钉和带袢钢板。术前和术后评估患者改良Lysholm膝关节评分、临床有效率、松弛度、活动度、MRI(核磁共振)检查结果、并发症发生率。结果 :两组患者术后膝关节功能评分均有显著改善。在功能评分、临床有效率、松弛度和活动度方面没有观察到差异。没有观察到重大的术中或术后并发症,例如感染、血管或神经损伤。结论 :两组的膝关节功能评分均在前交叉韧带重建术后得到改善。两组的功能评分和活动度差异不显著。与施乐辉公司相比,德美公司的PEEK界面螺钉和带袢钢板具有非劣效性。德美公司的PEEK界面螺钉和带袢钢板适用于关节镜下前交叉韧带重建。

Objective To evaluate the clinical efficacy of Delta Medical's PEEK(polyether ether ketone)interface screws and EndoButton compared to Smith&Nephew's PEEK interface screws and EndoButton in patients undergoing arthroscopic anterior cruciate ligament(ACL)reconstruction.Methods Sixteen patients with ACL injury who underwent arthroscopic ACL reconstruction at Hunan Provincial People's Hospital(the First Affiliated Hospital of Hunan Normal University)between November 2017 and July 2019 were randomly assigned to two groups of 8 patients each.The observation group used Delta Medical's PEEK interface screws and EndoButton,while the control group used Smith&Nephew's PEEK interface screws and EndoButton.The patients were evaluated before and after surgery for Lysholm knee joint score,clinical efficacy rate,laxity,activity,MRI examination results,and incidence of complications.Results The knee joint function scores improved significantly in both groups after surgery.No differences were observed in functional scores,clinical efficacy rates,laxity,and activity.There were no major intraoperative or postoperative complications,such as infection,vascular or nerve injury.Conclusion The knee joint function scores improved after anterior cruciate ligament reconstruction in both groups.There was no significant difference in functional scores and activity between the two groups.Compared with Smith&Nephew,Delta Medical's PEEK interface screws and EndoButton demonstrated non-inferiority.Delta Medical's PEEK interface screws and EndoButton are suitable for arthroscopic anterior cruciate ligament reconstruction.