Chinese Journal of Tissue Engineering Research ›› 2018, Vol. 22 ›› Issue (19): 3039-3043.doi: 10.3969/j.issn.2095-4344.0284

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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

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

CLC Number: