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  

Safety and efficacy of a novel knee prosthesis for knee arthroplasty: study protocol for a prospective, randomized, positive parallel controlled, non-inferiority, clinical trial

作　　者：李治锋[1] 孙景东[1] 张江[1] 龚泰芳[1] 

机构地区：[1]十堰市太和医院(北医药学院附属医院)科1区,湖北省十堰市442000

出　　处：《中国组织工程研究》2017年第23期3609-3615,共7页Chinese Journal of Tissue Engineering Research

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�BACKGROUND： Total knee arthroplasty is the main treatment for end-stage knee disease. However, knee prostheses are mostly imported from overseas, making the price expensive. Furthermore, ethnic differences mean that these prostheses designed for westerners are not designed to meet the needs of Orientals. OBJECTIVE： To verify the efficacy and safety of this novel knee prosthesis in total knee arthroplasty. METHODS： We propose to conduct a prospective, single-center, randomized, positive parallel controlled, non-inferiority, clinical trial at Shiyan Taihe Hospital, China. Seventy-two patients with knee disease who are scheduled to undergo knee arthroplasty will be equally randomized into the trial group or the control group using a randomized block design. The trial and control groups will undergo knee arthroplasty with knee prostheses purchased from Wuhan ~ijiabao Biomaterial Co., Ltd., Wuhan, China （newly developed） and Beijing AKEC Medical Co., Ltd., Beijing, China （approved by the China Food and Drug Administration）, respectively. All patients will be followed up for 12 months. The primary outcome will be the recovery of knee function as assessed by the rate of excellent and good Hospital for Special Surgery knee scores at postoperative 12 months （＋ 15 days）. The secondary outcomes will be： the morphology of the knee as revealed by anteroposterior and lateral radiographic views taken preoperatively, and at postoperative 2 weeks （＋ 5 days）, 6 weeks （＋ 15 days）, 3 months （＋ 15 days）, 6 months （＋ 15 days）, and 12 months （＋ 15 days）; the incidence of adverse reactions at postoperative 2 weeks （＋ 5 days）, 6 weeks （＋ 15 days）, 3 months （＋ 15 days）, 6 months （＋ 15 days）, and 12 months （＋ 15 days）; and the correlation between various types of adverse reactions and each knee prosthesis type. This trial has been registered at ClinicaITrials.gov （identifier： 03184129）. The study protocol has been approved by the Ethics Committee of Tai

关 键 词：骨科植入物 人工假体 膝关节假体 人工膝关节置换 安全性 有效性 不良反应 铺铬钼合金 高交联聚乙烯 非劣效性临床试验 临床试验 

分 类 号：R318[医药卫生—生物医学工程]