- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950036
Research on Acetabular Labrum Injury Based on MR: Multi-angle Deep Learning Model
June 29, 2021 updated by: Peking University Third Hospital
The purpose of this study is to study the MRI images of acetabular labrum injury by deep learning method, and try to establish a combination model of axial and coronal serial images, and compare with the diagnostic accuracy of radiologists, to establish a deep learning method for accurate identification and classification of acetabular labrum injury.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Detection of acetabular labrum images based on CNN: axial and coronal T2-fs images were used, and all images were corrected and standardized. CNN is applied to recognize and learn the images with acetabular labrum to select the images with acetabular labrum structure from the complete sequence and delete the images without acetabular labrum structure. 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 acetabular labrum based on Densenet: using Densenet to recognize and learn the acetabular labrum from the selected images. LabelImg was used to locate the acetabular labrum coordinates manually and then input them into Python for recognition learning. All the data were divided into a training set (70%, and then 30% in the training set was selected as the verification set), and 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. Finally, input the result to the next step.
- Identification and grading of acetabular labrum injury based on 3D-CNN: the input data were identified and graded by the 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 were divided into a training set (70%, and then 30% of the training set was selected as the verification set), and the remaining 30% was used as the test set to evaluate the classification accuracy to identify the injury of the labrum and classify the cases with injury.
- Combination model: according to the above process (1-3), after the models are established for the axial and coronal images respectively, according to the output characteristics of the CNN classification model, the probabilities of different grades are predicted before the output results, and the output results are based on these probabilities to select the expression form of the maximum possible probability. Our combination model averages the probabilities of these different classifications, calculates the final prediction probability, and then obtains the final model. The test set of the third step (including the mixed data of axial and coronal images) was used to verify the model.
- Comparison of radiologists and deep learning: List the test set cases in the above step 3 and ask two MSK professional radiologists to classify whether there is damage and the degree of damage, and compared with the results with artificial diagnosis (both doctors read the images independently and obtained the diagnosis results by simulating the normal state of writing the report without any prompt). Finally, the accuracy of artificial diagnosis was compared with that of the combination model obtained in the fourth step.
Study Type
Observational
Enrollment (Actual)
1261
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From September 2018 to September 2020, MRI was performed in the Department of Radiology, the Third Hospital of Peking University.
Description
Inclusion Criteria:
- Without any treatment before imaging examination;
- MR of the hip joint was performed within three 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 hip 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 hip was normal, and the labrum 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 hip showed labrum 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 hip revealed partial or complete loss of labrum.
|
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 |
|---|---|---|
|
Research on acetabular labrum injury based on MR: multi-angle deep learning model
Time Frame: 2020.12.01-2021.05.30
|
The model of deep learning was obtained for diagnosis and grading of labrum injury and compared with the doctors of different stages.
|
2020.12.01-2021.05.30
|
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)
December 1, 2020
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
May 30, 2021
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 2, 2021
Study Record Updates
Last Update Posted (Actual)
July 2, 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
- M2020459
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.
Clinical Trials on Labrum Injury of the Hip Joint
-
University of Missouri-ColumbiaRecruitingHip Arthroscopy | Femoroacetabular Impingement Syndrome | Labrum Injury of the Hip JointUnited States
-
Move Up SASRecruitingRotator Cuff Tears of the Shoulder | Labrum InjuryFrance
-
University of AarhusCompleted
-
ArthroBiologix Inc.RecruitingOsteoarthritis | Femoroacetabular Impingement Syndrome | Labrum Injury of the Hip JointCanada
-
Smith & Nephew, Inc.Active, not recruitingAdvanced Degeneration of the Hip Joint | Revision of the Hip JointUnited States, Australia, Canada, Hong Kong
-
The Hawkins FoundationCompletedAcetabular Labrum Tear | Hip Dysplasia | Femoroacetabular ImpingementUnited States
-
Washington University School of MedicineNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedAcetabular Labrum Tear | Rehabilitation | Femoroacetabular Impingement | Hip Pain | Acetabular DysplasiaUnited States
-
Hadassah Medical OrganizationUnknown
-
Hongwen XuTongji Hospital; Wuhan Union Hospital, China; Hunan Children's Hospital; Shenzhen... and other collaboratorsNot yet recruitingReduction | Developmental Dislocation of the Hip | Congenital Dislocation of Hip | Residual Deformity
-
The Fuzhou No 2 HospitalCompletedDevelopmental Dislocation of the Hip | Reduction Deformity of Limb
Clinical Trials on Diagnostic Test
-
Hospital Clínica KennedyCompletedStroke | Insomnia | Ischemic Heart Disease | Sleep-disordered Breathing | HypersomniaEcuador
-
Hospices Civils de LyonCompleted
-
Istanbul UniversityRecruitingCleft Lip and Palate | Dental Age EstimationTurkey
-
Hospital St. Joseph, Marseille, FranceCompleted
-
Peking Union Medical College HospitalRecruitingPheochromocytoma/Paraganglioma (PPGL)China
-
Neptune MedicalH-T. Centrum Medyczne Sp. z o.o. sp. k; KCRINot yet recruitingColorectal Neoplasms | Colonoscopy | Gastrointestinal Endoscopy | Colorectal Cancer ScreeningPoland
-
Technical University of MunichCharite University, Berlin, Germany; University Hospital Erlangen; Max-Planck...Not yet recruiting
-
Suleyman Demirel UniversityRecruiting
-
Institute of Cardiometabolism and Nutrition, FranceEnrolling by invitationInduced Pluripotent Stem CellsFrance
-
CDx DiagnosticsCompletedBarrett Esophagus | Esophageal Adenocarcinoma | Esophageal DysplasiaBelgium