跳至主要内容
临床试验/NCT03541122
NCT03541122Unknown不适用

Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia: a Self-controlled, Diagnostic Trial

Hebei Medical University Third Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
The sensitivity of offshoring index (OFI)

研究概览

简要总结

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. Herein, the investigators describe the protocol 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 the investigators expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.

详细描述

Acetabular dysplasia is a developmental malformation of the hip joint where the acetabulum become shallow and cannot fully cover the femoral head and the centre of the hip joint moves outward, resulting in an increased risk for joint subluxation or dislocation.

Current diagnosis of acetabular dysplasia mainly depends on the pelvic anteroposterior X-ray film to understand whether there is dislocation of the hip joint, whether the concentricity of the femoral head and acetabulum is consistent, and whether there is secondary osteoarthritis or other hip diseases, such as femoral head ischemic necrosis, hip joint tuberculosis, and rheumatoid arthritis. The commonly used measurement indicators include centre-edge (CE) angle, acetabular angle (Sharp angle), and acetabular head index (AHI). Moreover, some differences exist in the measurement results between male and female patients. Acetabular dysplasia often accompanies by acetabular bone hyperplasia and necrosis of the femoral head, which have a greater impact on radiographic measurements, especially when measured with angles. It is difficult to determine the radiological landmark for the lateral edge of the acetabular roof due to the existence of bone hyperplasia, which produces a great influence on the accuracy of the measurement of the centre-edge angle and Sharp angle.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No experience in hip replacement, pelvic fixation or external fixation, and proximal femoral surgery;
  • No marked pelvic tilt;
  • No hip dislocation;
  • No obvious hip deformity, such as significant collapse of the femoral head and severe hip traumatic arthritis;
  • No significant lesions in the pelvis or proximal femur;
  • Aged over 16 years;
  • Provision of written informed consent.

排除标准

  • Those with advanced osteoarthritis;
  • Those with osteoarthritis secondary to acetabular dysplasia;
  • Those with ankylosing spondylitis involving the hip joint;
  • Those with rheumatoid arthritis;
  • Those with inflammatory inflammation of the hip joint;
  • Those with tumor lesions in the hip joint.

结局指标

主要结局

The sensitivity of offshoring index (OFI)

时间窗: One day after hospitalization

The sensitivity represents the percentage of actual patients who are correctly diagnosed with a disease. A higher sensitivity indicates a higher rate of correct diagnosis for acetabular dysplasia.

次要结局

  • The specificity of OFI,MUI and TBOI(One day after hospitalization)
  • The positive predictive value of OFI,MUI and TBOI(One day after hospitalization)
  • The negative predictive value of OFI,MUI and TBOI(One day after hospitalization)
  • The positive likelihood ratio of OFI,MUI and TBOI(One day after hospitalization)
  • The negative likelihood ratio of OFI,MUI and TBOI(One day after hospitalization)

研究者

发起方
Hebei Medical University Third Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Di Qin

Principal Investigator

Hebei Medical University Third Hospital

研究点 (1)

Loading locations...

相似试验