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临床试验/NCT06372873
NCT06372873进行中(未招募)不适用

Deep Learning-enabled Ultrasound Classification of Anterior Talofibular Ligament Injury in China: A Retrospective, Multicentre, Diagnostic Study

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,000
试验地点
1
主要终点
To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard

研究概览

简要总结

Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.

The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 18 years old
  • patients who had experienced an first-episode, acute ankle sprain and received US examination within 14 days post injury
  • patients who had a corresponding arthroscopic surgery result for classification of the ATFL injury.

排除标准

  • patients who had a previous history of ankle open trauma or ankle joint surgery
  • there were any soft-tissue or bone tumors in the ankle
  • there was concurrent with any other rheumatoid arthritis
  • the image quality was low or there were severe artifacts (eg, anisotropic artifacts)

结局指标

主要结局

To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard

时间窗: Baseline

The radiologists in our clinical center will re-evaluate whether the US images are in consensus with the classification of ATFL injury of its reference standard

次要结局

未报告次要终点

研究者

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

Zhu Jiaan

Chairman

Peking University People's Hospital

研究点 (1)

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