Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury
Deep Learning-enabled Ultrasound Classification of Anterior Talofibular Ligament Injury in China: A Prospective, Multicentre, Diagnostic Study
1 other identifier
observational
400
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedStudy Start
First participant enrolled
April 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedApril 18, 2024
April 1, 2024
1 month
April 15, 2024
April 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
classification of ATFL injury
ultrasound classification of ATFL injury versus surgery results
Baseline
Study Arms (1)
Experimental group
Interventions
The investigators made ultrasound examinations to the participants to test whether the model could improve their diagnostic accuracy
Eligibility Criteria
As mentioned above
You may qualify if:
- age\> 18 years old
- patients who underwent an acute ankle sprain
- patients with a surgery results of the sprained ankle
You may not qualify if:
- age\< 18 years old
- patients with a previous history of ankle surgery
- patients with ankle tumors
- patients with a previous history of rheumatoid arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100032, China
Related Publications (2)
Gribble PA, Bleakley CM, Caulfield BM, Docherty CL, Fourchet F, Fong DT, Hertel J, Hiller CE, Kaminski TW, McKeon PO, Refshauge KM, Verhagen EA, Vicenzino BT, Wikstrom EA, Delahunt E. Evidence review for the 2016 International Ankle Consortium consensus statement on the prevalence, impact and long-term consequences of lateral ankle sprains. Br J Sports Med. 2016 Dec;50(24):1496-1505. doi: 10.1136/bjsports-2016-096189. Epub 2016 Jun 3.
PMID: 27259753BACKGROUNDKramer Z, Woo Lee Y, Sherrick R. Acute Ankle Sprains. Clin Podiatr Med Surg. 2023 Jan;40(1):117-138. doi: 10.1016/j.cpm.2022.07.008.
PMID: 36368838BACKGROUND
Study Officials
- STUDY CHAIR
Jiaan Zhu, Dr
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 18, 2024
Study Start
April 20, 2024
Primary Completion
May 30, 2024
Study Completion
December 30, 2025
Last Updated
April 18, 2024
Record last verified: 2024-04