保留股骨颈型髋关节假体置换中假体周围骨折对髋关节功能恢复的影响:前瞻性、单中心、自身对照、2年随访临床试验  

Effect of periprosthetic fracture on hip function after femoral neck-preserving total hip arthroplasty: study protocol for a prospective, single-center, self-controlled trial with 2-year follow-up

作　　者：秦迪[1] 韩永台[1] 李会杰[1] 

机构地区：[1]河北医科大学第三医院骨病科,河北省石家庄市050051

出　　处：《中国组织工程研究》2016年第53期7985-7991,共7页Chinese Journal of Tissue Engineering Research

基　　金：河北省医学科学研究重点课题计划项目(20150267)~~

摘　　要：背景:研究表明,保留股骨颈型髋关节置换可降低髋关节置换患者置换后并发症,为远期翻修保留更多骨量,但在术中易出现股骨假体周围骨折,严重影响患者置换后髋关节功能恢复。目的:试验采用前瞻性分析方法,分析保留股骨颈型髋关节置换中发生假体周围骨折的危险因素,提出预防措施,以期降低该并发症的发生率。方法:研究为前瞻性、单中心、自身对照、2年随访、开放性临床试验方案,在中国河北省石家庄市,河北医科大学第三医院骨病科完成。纳入保留股骨颈型髋关节置换中假体周围骨折患者25例,对其置换前及置换后的X射线片和CT检测影像学指标参数进行分析。试验的主要观察指标为置换前和置换后6,12,24个月的髋关节功能Harris评分评估患者置换后髋关节功能恢复情况。试验的次要观察指标为关节置换中患者AAOS假体周围骨折分型结果,评估患者股骨假体周围骨折严重程度;置换前和置换后6,12,24个月患者影像学指标参数评估骨折愈合情况,包括中近端股骨骨折髓腔参数:小转子中点上方20 mm髓腔宽度、小转子中点髓腔宽度、小转子中点下方20 mm髓腔宽度、骨折线髓腔及对应假体宽度,转子间窝距离,股骨颈干角,前倾角,股骨颈长度,患者假体末端与髓腔间距冠状径之比、股骨距高度;试验的其他观察指标为影响保留股骨颈型髋关节置换中发生假体周围骨折患者髋关节功能恢复危险因素的多元Logistic回归分析结果及置换后24个月的不良反应发生率。试验于2016年11月24日在北美临床试验注册中心注册(NCT02981823);试验经中国河北省石家庄市河北医科大学第三医院伦理委员会批准(KE2016-011-1),研究方案中项目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:试验详细分析保留股骨颈型髋关节BACKGROUND： Total hip replacement with a collum femoris preserving（CFP） short stem prosthesis can reportedly reduce postoperative complications and preserve maximum bone tissue for long-term revision. However, CFP replacement has a relatively high risk of intraoperative periprosthetic fractures that can seriously harm hip function recovery.OBJECTIVE： To analyze risk factors for periprosthetic fractures and develop preventive measures to reduce postoperative complications. METHODS： A prospective, single-center, self-controlled, open-label clinical study with 2-year follow-up will be carried out at the Department of Orthopedics, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. We will analyze imaging data from 25 patients who undergo total hip replacement with the CFP prosthesis. Primary outcome measure is hip function recovery as assessed by Harris hip score preoperatively and 6, 12, and 24 months postoperatively. Secondary outcome measures include fracture severity as assessed by periprosthetic fracture classification according to the American Academy of Orthopaedic Surgeons guidelines, and bone healing as assessed by CT and radiographic findings preoperatively and 6, 12, and 24 months postoperatively, including parameters of the proximal and mesal medullary cavity of the fractured femur（width of the medullary cavity at the point 20 mm above the midpoint of the small trochanter, at the midpoint of the small trochanter, at the point 20 mm below the midpoint of the small trochanter, and at the fracture line; width of the corresponding prostheses）, intertrochanteric width, femoral neck-stem angle, femoral neck anteversion, femoral neck length, ratio of the distal end of the prosthesis to the medullary space, and height of the femoral calcar. Other outcome measures are multiple logistic regression analysis results of risk factors for periprosthetic fracture during hip replacement, and the incidence of adverse events within 24 months postoperatively. This study was registe

关 键 词：组织工程 关节成形术 置换 髋 髋臼 骨科植入物 骨植入物 临床试验 髋关节置换 X射线 CT检查 多元LOGISTIC回归分析 髋关节功能Harris评分髓腔 危险因素 不良反应 自身对照试验 

分 类 号：R318[医药卫生—生物医学工程]