中国组织工程研究

中国组织工程研究 ›› 2018, Vol. 22 ›› Issue (19): 3039-3043.doi: 10.3969/j.issn.2095-4344.0284

• 骨与关节生物力学 bone and joint biomechanics • 上一篇    下一篇

股骨头外移、上移及泪滴基线外移指数对成人髋臼发育不良的诊断价值：自身对照，诊断性试验及预试验结果

秦 迪，胡世伟，李会杰，何丽英，吴啸波，吴 涛，马文辉，韩永台   

  1. 河北医科大学第三医院，河北省石家庄市  050051
  • 出版日期:2018-07-08 发布日期:2018-07-08
  • 通讯作者: 韩永台，硕士，主任医师，教授，硕士生导师。
  • 作者简介:秦迪，男，1982年生，湖北省人，汉族，2009年毕业于河北医科大学，硕士，主治医师。
  • 基金资助:

    河北省医学科学研究重点课题计划项目(20180457)

Offshoring index, moving up index and teardrop baseline offshoring index of the femoral head for diagnosis of adult acetabular dysplasia: study protocol for a self-controlled, diagnostic trial and preliminary results  

Qin Di, Hu Shi-wei, Li Hui-jie, He Li-ying, Wu Xiao-bo, Wu Tao, Ma Wen-hui, Han Yong-tai   

  1. the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
  • Online:2018-07-08 Published:2018-07-08
  • Contact: Han Yong-tai, Master, Chief physician, Professor, Master’s supervisor, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
  • About author:Qin Di, Master, Attending physician, the Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
  • Supported by:

    the Hebei Provincial Key Project of Medical Science Research in China, No. 20180457

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摘要：

文章快速阅读：




文题释义：
泪滴基线外移指数：即股骨头中心点与髋臼外上缘点分别到泪滴的垂直距离的比值×100%。
头臼指数：从股骨头内侧缘到髋臼外缘点的距离 A 与股骨头的横径 B 的比值，表示股骨头的大小与髋臼深度不相称的状态。
 
摘要
背景：髋臼发育不良患者常合并髋臼骨质增生、股骨头坏死，会使股骨头中心点位置发生改变，这样在使用骨盆X射线成像测量影像学诊断指标——中心边缘角、髋臼角、头臼指数时就会存在误差，从而影响髋臼发育不良诊断的准确性。
目的：试验提出了3种新的X射线指标测量方法，分别测量股骨头外移指数、上移指数、泪滴基线外移指数的变化，这些结果指标均用相对比值表示，可规避测量角度带来诊断成人髋臼发育不良导致的误差，以期对髋臼发育不良做出更准确的诊断。
方法：试验在中国河北省，河北医科大学第三医院完成。纳入行骨盆正位X射线片检查的成人患者200例，男女各100例，采用Photoshop CS5软件对X射线图像进行健侧及患侧影像学指标测量及分析。试验的主要观察指标为股骨头外移指数对成人髋臼发育不良诊断的敏感度；次要观察指标为股骨头外移指数对成人髋臼发育不良诊断的特异度、阳性预测值、阴性预测值、阳性似然比、阴性似然比及诊断正确率，股骨头上移指数、泪滴基线外移指数对成人髋臼发育不良诊断的敏感度特异度，特异、阳性预测值、阴性预测值、阳性似然比、阴性似然比及诊断正确率，股骨头外移指数、上移指数、泪滴基线外移指数与中心边缘角、髋臼角、头臼指数的相关性，影响髋关节功能的危险因素Logistic回归分析结果。目前试验已得到241例骨盆正位X射线检查的男性患者的数据结果，显示患侧外移指数、上移指数、泪滴基线外移指数分别为(86.8±0.6)%，(75.8±2.0)%及(76.2±0.5)%，此3个指数与髋关节CE角、Sharp 角及头臼指数具有一定相关性。试验经中国河北医科大学第三医院伦理委员会批准(批准单位：河北医科大学第三医院，批准号：KE2016-011-1)。研究符合世界医学会制定的《赫尔辛基宣言》的要求。参与者对试验方案和过程均知情同意，并签署知情同意书。文章结果将以科学会议报告，或在同行评议的期刊上发表传播。试验已在中国临床试验注册中心注册(注册号：ChiCTR1800016375)，注册方案版本号1.0。
讨论：试验结果旨在证实采用3种新的X射线指标(股骨头外移指数、上移指数、泪滴基线外移指数)的测量方法，与单纯指标测量中心边缘角、髋臼角，头臼指数相比较，可提高成人髋臼发育不良的诊断准确率，有效避免诊断误差。

关键词: 髋臼发育不良, 成人, 股骨头外移指数, 股骨头上移指数, 股骨头泪滴基线外移指数, 中心边缘角, 髋臼角, 头臼指数, 髋关节Harris评分, 诊断性试验, 敏感性, 特异性, 临床试验

Abstract:

BACKGROUND: Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head. Thus, measurement errors will be generated on the anteroposterior radiographs of the adult pelvis involving centre-edge angle, acetabular angle (Sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia.

OBJECTIVE: To verify three novel X-ray indicators, including offshoring index (OFI), moving up index (MUI) and teardrop baseline offshoring index (TBOI) of the femoral head. All data will be expressed as relative ratios, as we expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.
METHODS: A trial will be conducted at the Third Hospital of Hebei Medical University in China. Two hundred adult patients (100 females and 100 males) undergoing pelvic X-ray examinations will be enrolled as the study population. X-ray images of the affected and healthy pelvic sides will be measured and analyzed using Photoshop CS5 software. Primary outcome measure is the sensitivity of OFI of the femoral head for diagnosing adult acetabular dysplasia. Secondary outcome measures include the specificity, positive and negative predictive values, and positive and negative likelihood ratios of OFI of the femoral head for diagnosing adult acetabular dysplasia as well as the rate of correct diagnosis; specificity and sensitivity, positive and negative predictive values, and positive and negative likelihood ratios of MUI of the femoral head for diagnosis of adult acetabular dysplasia as well as the rate of correct diagnosis; specificity and sensitivity, positive and negative predictive values, and positive and negative likelihood ratios of TBOI of the femoral head for diagnosis of adult acetabular dysplasia as well as the rate of correct diagnosis; correlation of OFI, MUI and TBOI to centre-edge angle, Sharp angle and acetabular head index; and risk factors for hip function as analyzed by logistic regression analyses. In our pre-tests, pelvic X-ray data from 241 male patients showed that the OFI, MUI and TBOI were (86.8±0.6)%, (75.8±2.0)% and (76.2±0.5)%, which were certainly correlated to centre-edge angle, Sharp angle and acetabular head index. This trial has been approved by the Medical Ethics Committee of Third Hospital of Hebei Medical University of China (approval number: KE2016-011-1). The study protocol will be performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR1800016375). Protocol version (1.0).
DISCUSSION: This study is designed to verify that three new X-ray indicators, OFI, MUI and TBOI, as diagnostic indicators for adult acetabular dysplasia can increase diagnostic accuracy and effectively avoid diagnostic errors in comparison with the centre-edge angle, Sharp angle and acetabular head index.

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, Hip Joint, Femur Head Necrosis

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