本文選題：組織工程 + 膝關(guān)節(jié)��； 參考：《中國組織工程研究》2017年23期

【摘要】：背景:人工膝關(guān)節(jié)假體置換逐漸成為治療終末期膝關(guān)節(jié)疾病的主要手段。然而,目前中國臨床應(yīng)用的人工膝關(guān)節(jié)假體多為國外進(jìn)口產(chǎn)品,價(jià)格昂貴,同時(shí)由于人種差異,這些根據(jù)西方人解剖設(shè)計(jì)的假體也無法滿足東方人需要。目的:觀察新型膝關(guān)節(jié)假體應(yīng)用于人工膝關(guān)節(jié)置換的安全性和有效性。方法:研究為前瞻性、單中心、隨機(jī)、陽性平行對(duì)照、非劣效性臨床試驗(yàn),在中國湖北省,十堰市太和醫(yī)院完成。招募需要進(jìn)行膝關(guān)節(jié)置換的膝關(guān)節(jié)疾病患者72例,采用區(qū)組隨機(jī)化方法按1∶1的分配比例進(jìn)行分組,其中試驗(yàn)組和對(duì)照組各36例,分別采用武漢醫(yī)佳寶生物材料有限公司的新研制的膝關(guān)節(jié)假體及已獲得CFDA批準(zhǔn)的北京愛康宜誠醫(yī)療器材有限公司的膝關(guān)節(jié)假體進(jìn)行人工膝關(guān)節(jié)置換,隨訪12個(gè)月。試驗(yàn)的主要觀察指標(biāo)為置換后12個(gè)月(±15 d)膝關(guān)節(jié)HSS評(píng)分的優(yōu)良率,以評(píng)價(jià)膝關(guān)節(jié)功能恢復(fù)情況;試驗(yàn)的次要觀察指標(biāo)為置換后12個(gè)月患者的生存率,置換前、置換后2周(±5 d)、6周(±15 d)、3個(gè)月(±15 d)、6個(gè)月(±15 d)、12個(gè)月(±15 d)膝關(guān)節(jié)正側(cè)位X射線形態(tài),置換后2周(±5 d)、6周(±15 d)、3個(gè)月(±15 d)、6個(gè)月(±15 d)、12個(gè)月(±15 d)的不良反應(yīng)發(fā)生率及各種類型不良反應(yīng)與植入膝關(guān)節(jié)假體的相關(guān)性。試驗(yàn)已在北美臨床試驗(yàn)注冊(cè)中心注冊(cè)(NCT03184129),并經(jīng)中國十堰市太和醫(yī)院倫理委員會(huì)批準(zhǔn)(2016第(34)號(hào))。研究符合世界醫(yī)學(xué)會(huì)制定的《赫爾辛基宣言》的要求。參與者本人對(duì)治療方案和過程均知情同意,并簽署知情同意書。討論:試驗(yàn)于2017年2月開始招募對(duì)象,預(yù)計(jì)2017年9月完成招募,2018年11月完成數(shù)據(jù)分析。中國武漢醫(yī)佳寶生物材料有限公司根據(jù)中國人膝關(guān)節(jié)解剖特點(diǎn),研發(fā)出的一套全新的以鈷鉻鉬合金和高交聯(lián)聚乙烯為主要材料的人工膝關(guān)節(jié)假體系統(tǒng),該系統(tǒng)選用鈷鉻鉬對(duì)高交聯(lián)聚乙烯作為活動(dòng)摩擦界面,具有更加優(yōu)越的耐磨性能。試驗(yàn)希望驗(yàn)證新型膝關(guān)節(jié)假體進(jìn)行人工膝關(guān)節(jié)置換的有效性及安全性。
[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 (鹵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 (鹵5 days), 6 weeks (鹵15 days), 3 months (鹵15 days), 6 months (鹵15 days), 12 months (鹵15 days). The incidence of adverse reactions at 2 weeks (鹵5 days) and 6 weeks (鹵15 days), 3 months (鹵15 days), 6 months (鹵15 days), 12 months (鹵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.
【作者單位】： 十堰市太和醫(yī)院(湖北醫(yī)藥學(xué)院附屬醫(yī)院)骨科1病區(qū);
【分類號(hào)】：R687.4

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