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临床试验/NCT04455386
NCT04455386招募中不适用

Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Ligament Complex Injury of Ankle

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
1
主要终点
Morphology of ATFL and CFL

研究概览

简要总结

Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle

详细描述

Background: The lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function.

Method and objective: This study is a prospective diagnostic test. By comparing the sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, We aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.

排除标准

  • Acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage IV).

结局指标

主要结局

Morphology of ATFL and CFL

时间窗: before operation

Assess the ATFL and CFL through MRI of the ankle

status of ATFL and CFL

时间窗: during operation

evaluation of ATFL and CFL during operation

anterior talar translation and talar tilt

时间窗: before operation

Assess the instability through stress X ray of the ankle

length of ATFL and CFL in relax and stress position

时间窗: before operation

Assess the instability through Ultrasound of the ankle

次要结局

  • osteophyte(before operation)
  • avulsion fracture(before operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo Qinwei

associated professor

Peking University Third Hospital

研究点 (1)

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