- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04955067
Deep Learning of Anterior Talofibular Ligament: Comparison of Different Models
June 29, 2021 updated by: Peking University Third Hospital
The purpose of this study is to study the injury of the anterior talofibular ligament by deep learning method and compare a variety of different deep learning models to establish a deep learning method that can accurately identify and grade the injury of anterior talofibular ligament, and obtain a model with better recognition and grading effect.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- Recognition and segmentation of anterior talofibular ligament based on DenseNet. Densenet was used to recognize the axial T2-fs image, and the image level was the most typical one. The labelimg program based on Python was used to locate the coordinates of the anterior talofibular ligament and then imported into Python for learning. All the data were divided into a training set (70%, and then 30% of the training set was selected as the verification set). The remaining 30% was used as the test set to evaluate the accuracy of model recognition. After identifying the anterior talofibular ligament, the local clipping and amplification are carried out to remove the redundant information. Finally, input the result to the next step.
- Establishment and comparison of various deep learning models: four deep learning models were established and compared in this study, namely VGG19, AlexNet, CapsNet, and GoogleNet. The models using image fitting alone and those combining with clinical physical examination data were compared for each deep learning model. The diagnostic efficiency between models was expressed by the ROC curve, including AUC, F1 score, etc. the ROC curve was further analyzed by t-test, Delong test, and other statistical methods. In this study, the data were divided into a training set (70%, 30% in the training set as the validation set), and the remaining 30% as the test set to evaluate the classification accuracy.
Study Type
Observational
Enrollment (Anticipated)
1000
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
- Name: huishu Yuan, MD
- Phone Number: 15810245738
- Email: huishuy@bjmu.edu.cn
Study Contact Backup
- Name: Ming Ni, MD
- Phone Number: 13884794867
- Email: sdyingxiang2017@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 010
- Recruiting
- Peking University Third Hospital
-
Contact:
- Huishu Yuan, Dr
- Email: huishuy@bjmu.edu.cn
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From September 2018 to September 2020, patients underwent ankle MRI examination in the Department of Radiology, the Third Hospital of Peking University.
Description
Inclusion Criteria:
- Without any treatment before imaging examination;
- MR of ankle joint was performed within 3 months before operation and the image quality was good;
- Arthroscopic operation was performed in our hospital and the operation records were complete.
Exclusion Criteria:
- history of ankle surgery, history of cancer or previous fractures.
- Unclear image, serious artifact or incomplete clinical data.
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 |
|---|---|
|
Normal control group-Grade 0
Arthroscopic examination of the ankle joint was normal, and the ligament was intact without injury or tear.
|
The results of hip arthroscopy were taken as the gold standard, and MRI examination was taken as the research object
|
|
Ligament injury -Grade 1
Arthroscopic examination of the ankle joint showed ligament degeneration or injury, but no local or complete tear.
|
The results of hip arthroscopy were taken as the gold standard, and MRI examination was taken as the research object
|
|
Ligament tear-Grade 2
Arthroscopy of the ankle joint revealed partial or complete loss of ligaments.
|
The results of hip arthroscopy were taken as the gold standard, and MRI examination was taken as the research object
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Deep Learning of Anterior Talofibular Ligament: Comparison of Different Models
Time Frame: 2021.1-2022.3.1
|
The model of deep learning was obtained for diagnosis and grading of anterior fibular ligament and compared with the doctors of different grades.
|
2021.1-2022.3.1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: huishu Yuan, MD, Peking University Third Hospital
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 (Actual)
January 1, 2021
Primary Completion (Anticipated)
December 30, 2021
Study Completion (Anticipated)
March 30, 2022
Study Registration Dates
First Submitted
June 28, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
July 8, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- M2020460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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