骨水泥型与生物型髋关节假体置入修复老年不稳定股骨转子间骨折的疗效及安全性:前瞻性、非随机对照临床试验  

Effectiveness and safety of cemented versus cementless hip arthroplasty for senile unstable intertrochanteric fractures: study protocol for a prospective, nonrandomized, controlled clinical trial

作　　者：于铁淼[1] 苗会玲[2] 

机构地区：[1]哈励逊国际和平医院骨病科,河北省衡水市053000 [2]哈励逊国际和平医院体检科,河北省衡水市053000

出　　处：《中国组织工程研究》2017年第15期2308-2313,共6页Chinese Journal of Tissue Engineering Research

基　　金：基金资助:衡水市科技成果(201440076-2)~~

摘　　要：背景:由于不稳定股骨转子间骨折患者的年龄较大,身体功能逐渐退化加之此类疾病的复位固定较为困难,因此人工髋关节置换是治疗老年不稳定股骨转子间骨折的主要外科治疗方法之一。目的:观察骨水泥型与生物型髋关节假体置入修复老年不稳定股骨转子间骨折的疗效及安全性。方法:试验为前瞻性、单中心、非随机对照临床试验,在中国河北省哈励逊国际和平医院完成。选取不稳定股骨转子间骨折老年患者86例,均进行人工髋关节置换,对照组44例采用德国Link公司骨水泥型SPⅡ假体置换,试验组42例采用美国Zimmer公司Wagner生物型假体置换,随访6个月。试验的主要观察指标为以置换后6个月的髋关节Harris评分优良率以评估髋关节功能恢复情况;次要观察指标为置换前,置换后1,3,6个月髋关节Harris评分变化及髋关节X射线形态变化,术中出血量及手术时间,置换后1个月评估置换后输血量、下床活动时间及置换后引流量变化,置换后6个月不良反应发生率评估安全性。目前已获得的部分试验结果显示,试验组患者的置换后输血量及置换后引流量均高于对照组(P<0.05)。置换后6个月,试验组患者的髋关节Harris评分优良率、Harris评分及不良反应发生率与对照组比较差异无显著性意义(P>0.05),对照组出现骨水泥中毒4例。试验经中国河北省哈励逊国际和平医院伦理委员会批准[(院)2013-37)]。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者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2014年1月开始病例收集,预计2017年12月试验结束。目前临床应用于老年患者的髋关节假体主要有骨水泥型与生物型假体2种类型。试验希望明确骨水泥型假体和生物型假体置入修复不稳定股骨转子间骨折老年患者效果的差异,以期为老年不稳定股骨转子间骨折的髋关节BACKGROUND： For elderly patients with unstable intertrochanteric fractures, hip arthroplasty is mainly applied due to the degenerative body function and difficulty in reduction.OBJECTIVE： To investigate the effectiveness and safety of cemented versus cementless hip arthroplasty for senile unstable intertrochanteric fractures.METHODS： We are conducting a prospective, single-center, non-randomized, controlled clinical trial at the Harrison International Peace Hospital, China. Eighty-six elderly patients with unstable intertrochanteric fractures were enrolled and allotted to control （n=44） and experimental （n=42） groups, followed by treated with cemented and cementless hip arthroplasty, respectively. The follow-up time is 6 months. The primary outcome is good and excellent rate according to Harris hip scores at 6 months postoperatively. The secondary outcomes are Harris hip scores and hip morphology on X-ray at 1, 3 and 6 months postoperatively, intraoperative blood loss, operation time, blood transfusion volume,time of off-bed and drainage volume at 1 month postoperatively, as well as the safety based on the incidence of adverse events at 6 months postoperatively. Partial results show that the blood transfusion volume and drainage volume postoperatively in the experimental group were significaintly higher than those in the control group （P 〈 0.05）.There were no significant differences in the good and excellent rate according to Harris hip scores, Harris hip scores and incidence of adverse events between two groups at 6 months postoperatively （P 〉 0.05）. There were four cases of bone cement implantation syndrome in the control group. The study protocol has been approved by the Ethics Committee of Harrison International Peace Hospital of China, approval number 2013-37. 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 mem

关 键 词：组织工程 髋关节 股骨 骨科植入物 人工假体 临床试验 不稳定股骨转子间骨折 骨水泥型假体 生物型假体 老年 疗效 安全性 Harris评分 

分 类 号：R318[医药卫生—生物医学工程]