- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04953026
SLAP Injury of the Shoulder Joint: Application Value of Deep Learning in Diagnosis
June 29, 2021 updated by: Peking University Third Hospital
This study intends to study the shoulder SLAP injury through deep learning technology and establish a deep learning model through the combination of axial and oblique coronal images to establish a deep learning method that can accurately identify and grade shoulder SLAP injury.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
- Recognition of labrum images based on LeNet: axial and oblique coronal T2-fs images were used, and all images were corrected and standardized. LeNet identified the images with labrum of the shoulder joint, and the images with labrum structure of shoulder joint were selected from the complete sequence. In contrast, the images without labrum structure were deleted. All the data are divided into a training set (70%, 30% in training set as verification set), and the remaining 30% as a test set to evaluate the accuracy of model recognition. Enter the obtained results into the next step.
- Recognition and segmentation of glenoid lip of shoulder joint based on DenseNet: the labrum is recognized by DenseNet in the selected image. The labelimg software based on Python was used to locate the labrum coordinates and then input them into Python for recognition learning. All the data were divided into a training set (70% and 30% of the training set were selected as the verification set). The remaining 30% was used as the test set to evaluate the accuracy of model recognition. After identifying the labrum structure, the labrum structure is locally cut and enlarged to remove the redundant information and improve the recognition efficiency and accuracy. Finally, input the result to the next step.
- Recognition and grading of shoulder SLAP injury based on 3D-CNN: recognition and grading of input data through 3D-CNN model. 3D-CNN is divided into eight layers: input layer, hard wire layer H1, convolution layer C2, downsampling layer S3, convolution layer C4, downsampling layer S5, convolution layer C6 and output layer. 3D-CNN constructs a cube by stacking multiple consecutive frames and then uses a 3D convolution kernel in the cube. Through this structure, the feature images in the convolution layer will be connected with multiple adjacent frames in the previous layer to realize the information acquisition of continuous images. Similarly, the data is divided into a training set (70%, and then 30% of the training set is selected as the verification set), and the remaining 30% is used as the test set to evaluate the classification accuracy to identify whether there is labrum injury and grade the image with injury.
- Establish CNN combined model: after establishing the model for the axial and oblique coronal view according to the above process (1-3), according to the output characteristics of the CNN classification model, predict the probability of different grades before the output results, and the output results are based on these probabilities to select the expression form of the maximum possible probability. Our combined model averages the probabilities of these different classifications, calculates the final prediction probability, and then obtains the final joint model. The test set of the third step (including the mixed data of axial and coronal images) was used to verify the joint model.
Study Type
Observational
Enrollment (Anticipated)
800
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: +8613884794867
- Email: sdyingxiang2017@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 010
- Peking University Third 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Collect and analyze patients who underwent shoulder MR examinations in the Department of Radiology, Peking University Third Hospital from September 2018 to September 2020.
Description
Inclusion Criteria:
- Without any treatment before imaging examination;
- MR of the shoulder joint was performed within 3 months before the operation and the image quality was good;
- Arthroscopic operation was performed in our hospital, and the operation records were complete.
Exclusion Criteria:
- History of shoulder surgery, tumor, or previous fracture;
- 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
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Normal control group-Grade 0
Arthroscopic examination of the labrum was normal, and the labrum was intact without injury or tear.
|
The results of shoulder arthroscopy were taken as the gold standard, and MRI examination was taken as the research object.
|
|
Ligament injury -Grade 1
Arthroscopic examination of the shoulder showed labrum degeneration or injury, but no local or complete tear.
|
The results of shoulder arthroscopy were taken as the gold standard, and MRI examination was taken as the research object.
|
|
Ligament tear-Grade 2
Arthroscopy of the shoulder revealed partial or complete loss of labrum.
|
The results of shoulder 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 |
|---|---|---|
|
SLAP Injury of the Shoulder Joint: Application Value of Deep Learning in Diagnosis
Time Frame: 2021.10.1-2022.7.1
|
The model of deep learning was obtained for diagnosis and grading of SLAP injury and compared with the radiologists of different stages.
|
2021.10.1-2022.7.1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
October 1, 2021
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 7, 2021
Study Record Updates
Last Update Posted (Actual)
July 7, 2021
Last Update Submitted That Met QC Criteria
June 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2020458
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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