Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury

April 15, 2024 updated by: Zhu Jiaan, Peking University People's Hospital

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

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. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

As mentioned above

Description

Inclusion Criteria:

  • age> 18 years old
  • patients who underwent an acute ankle sprain
  • patients with a surgery results of the sprained ankle

Exclusion Criteria:

  • age< 18 years old
  • patients with a previous history of ankle surgery
  • patients with ankle tumors
  • patients with a previous history of rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental group
Other: Ultrasound examination
The investigators made ultrasound examinations to the participants to test whether the model could improve their diagnostic accuracy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
classification of ATFL injury
Time Frame: Baseline
ultrasound classification of ATFL injury versus surgery results
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Chair: Jiaan Zhu, Dr, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2024

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023PHB211-001(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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