中国组织工程研究

中国组织工程研究 ›› 2017, Vol. 21 ›› Issue (23): 3609-3615.doi: 10.3969/j.issn.2095-4344.2017.23.001

• 人工假体 artificial prosthesis •    下一篇

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

李治锋，孙景东，张 江，龚泰芳   

  1. 十堰市太和医院(湖北医药学院附属医院)骨科1病区，湖北省十堰市 442000
  • 出版日期:2017-08-18 发布日期:2017-09-01
  • 通讯作者: 龚泰芳，博士，主任医师，教授。十堰市太和医院(湖北医药学院附属医院)骨科1病区，湖北省十堰市 442000
  • 作者简介:李治锋，男，1985年生，湖北省十堰市人，汉族，硕士，医师。

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

Li Zhi-feng, Sun Jing-dong, Zhang Jiang, Gong Tai-fang   

  1. First Orthopedics Ward, Shiyan Taihe Hospital & the Affiliated Hospital of Hubei University of Medicine, Shiyan 442000, Hubei Province, China
  • Online:2017-08-18 Published:2017-09-01
  • Contact: Gong Tai-fang, M.D., Chief physician, Professor, First Orthopedics Ward, Shiyan Taihe Hospital & the Affiliated Hospital of Hubei University of Medicine, Shiyan 442000, Hubei Province, China
  • About author:Li Zhi-feng, Master, Physician, First Orthopedics Ward, Shiyan Taihe Hospital & the Affiliated Hospital of Hubei University of Medicine, Shiyan 442000, Hubei Province, China

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摘要：

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文题释义：
人工膝关节置换：是在近代人工髋关节成功应用于患者后逐渐发展起来的一种治疗膝关节疾病的新技术，它能非常有效地根除晚期膝关节病痛，极大地提高患者的生活质量。
深静脉血栓形成：是指血液在深静脉不正常的凝结，好发于下肢，在急性阶段不能得到及时诊断和处理，一些血栓可能会脱落，造成患者的肺、脑等重要脏器的栓塞而导致死亡。
 
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。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程
ORCID: 0000-0003-1838-9459(龚泰芳)

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, 钴铬钼合金, 高交联聚乙烯, 非劣效性临床试验, 临床试验

Abstract:

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 Yijiabao 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 ClinicalTrials.gov (identifier: 03184129). The study protocol has been approved by the Ethics Committee of Taihe Hospital of China (approval number: 2016 (34)). All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki. Written informed consent was provided by each patient and their family members after they indicated that they fully understood the treatment plan.
DISCUSSION: Participant recruitment began in February 2017 and will be finished in September 2017. Data analysis will be completed in November 2018. Wuhan Yijiabao Biomaterial Co., Ltd. has developed a new knee prosthesis system. This system uses cobalt-chrome-molybdenum and high cross-linked polyethylene as the active friction interface, which has excellent wear resistance. This trial is designed to verify the efficacy and safety of this novel knee prosthesis in total knee arthroplasty.

 
中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Knee Joint, Vitallium

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