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NCT06373029 Clinical Trial

Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury

Ultrasound Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06373029
Other study ID # 2023PHB211-001(2)
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date December 30, 2025

Study information
Verified date April 2024
Source Peking University People's Hospital
Contact Jiaan Zhu, Dr
Phone +8613581902236
Email canzhujia@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date December 30, 2025
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Ultrasound examination
The investigators made ultrasound examinations to the participants to test whether the model could improve their diagnostic accuracy

Locations
Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Kramer 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. Erratum In: Clin Podiatr Med Surg. 2023 Apr;40(2):xi. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary classification of ATFL injury ultrasound classification of ATFL injury versus surgery results Baseline
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