新型膝关节假体应用于人工膝关节置换的安全性和有效性:前瞻性、随机、阳性平行对照、非劣效性临床试验

发布时间：2018-05-27 23:47

本文选题：组织工程 + 膝关节　；参考：《中国组织工程研究》2017年23期

【摘要】：背景:人工膝关节假体置换逐渐成为治疗终末期膝关节疾病的主要手段。然而,目前中国临床应用的人工膝关节假体多为国外进口产品,价格昂贵,同时由于人种差异,这些根据西方人解剖设计的假体也无法满足东方人需要。目的:观察新型膝关节假体应用于人工膝关节置换的安全性和有效性。方法:研究为前瞻性、单中心、随机、阳性平行对照、非劣效性临床试验,在中国湖北省,十堰市太和医院完成。招募需要进行膝关节置换的膝关节疾病患者72例,采用区组随机化方法按1∶1的分配比例进行分组,其中试验组和对照组各36例,分别采用武汉医佳宝生物材料有限公司的新研制的膝关节假体及已获得CFDA批准的北京爱康宜诚医疗器材有限公司的膝关节假体进行人工膝关节置换,随访12个月。试验的主要观察指标为置换后12个月(±15 d)膝关节HSS评分的优良率,以评价膝关节功能恢复情况;试验的次要观察指标为置换后12个月患者的生存率,置换前、置换后2周(±5 d)、6周(±15 d)、3个月(±15 d)、6个月(±15 d)、12个月(±15 d)膝关节正侧位X射线形态,置换后2周(±5 d)、6周(±15 d)、3个月(±15 d)、6个月(±15 d)、12个月(±15 d)的不良反应发生率及各种类型不良反应与植入膝关节假体的相关性。试验已在北美临床试验注册中心注册(NCT03184129),并经中国十堰市太和医院伦理委员会批准(2016第(34)号)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者本人对治疗方案和过程均知情同意,并签署知情同意书。讨论:试验于2017年2月开始招募对象,预计2017年9月完成招募,2018年11月完成数据分析。中国武汉医佳宝生物材料有限公司根据中国人膝关节解剖特点,研发出的一套全新的以钴铬钼合金和高交联聚乙烯为主要材料的人工膝关节假体系统,该系统选用钴铬钼对高交联聚乙烯作为活动摩擦界面,具有更加优越的耐磨性能。试验希望验证新型膝关节假体进行人工膝关节置换的有效性及安全性。
[Abstract]:Background: artificial knee prosthesis replacement has gradually become the main treatment of end-stage knee disease. However, at present, most of the prosthetic knee prostheses used in China are imported from abroad, which are expensive, and because of the ethnic differences, these prostheses designed according to the anatomy of Westerners can not meet the needs of the oriental. Objective: to observe the safety and efficacy of new knee prosthesis in knee arthroplasty. Methods: the study was carried out in Taihe Hospital, Shiyan City, Hubei Province, China. 72 patients with knee joint disease who needed knee arthroplasty were recruited and divided into two groups according to the 1:1 distribution ratio by block randomization, including 36 cases in the experimental group and 36 cases in the control group. The knee joint prosthesis of Wuhan Yijiabao Biomaterials Co., Ltd. and the knee joint prosthesis of Beijing Aikang Yicheng Medical equipment Co., Ltd. which has been approved by CFDA were used respectively. The follow-up was 12 months. The main observation index of the experiment was the excellent and good rate of HSS score of knee joint 12 months after replacement (卤15 days) to evaluate the recovery of knee joint function, the second observation index of the trial was survival rate of patients at 12 months after replacement, before replacement. Two weeks after replacement (卤5 days), 6 weeks (卤15 days), 3 months (卤15 days), 6 months (卤15 days), 12 months (卤15 days). The incidence of adverse reactions at 2 weeks (卤5 days) and 6 weeks (卤15 days), 3 months (卤15 days), 6 months (卤15 days), 12 months (卤15 days) and the correlation between various types of adverse reactions and knee prosthesis implantation. The trial has been registered at the North American Clinical trial Registry (NCT03189129) and has been approved by the Ethics Committee of Taihe Hospital of Shiyan City, China. The study meets the requirements of the Helsinki Declaration formulated by the World Medical Association. Participants themselves have informed consent and signed informed consent to the treatment plan and procedure. Discussion: the trial began in February 2017 and is expected to complete recruitment in September 2017 and data analysis in November 2018. According to the anatomical characteristics of the Chinese knee joint, Wuhan Yijiabao Biomaterials Co., Ltd. has developed a new artificial knee prosthesis system with cobalt, chromium, molybdenum alloy and high crosslinked polyethylene as the main materials. The system uses cobalt, chromium and molybdenum as active friction interface to high crosslinked polyethylene, and has better wear resistance. The purpose of this study is to verify the effectiveness and safety of new knee prosthesis.
【作者单位】：十堰市太和医院(湖北医药学院附属医院)骨科1病区;
【分类号】：R687.4

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