- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04527029
Early Intelligent Diagnosis of Limb Deformity in Children by AI and Clinic Application
April 10, 2022 updated by: Children's Hospital of Fudan University
The Studies of Early Intelligent Diagnosis of Limb Deformity in Children by AI and Clinic Application
The limb deformity in children include congenital limb malformations or acquired from the damage of epiphyseal plate which caused by tumor, inflammation and trauma.
Due to the complexity of the disease itself, rapid dynamic development and the characteristics of children's growth and development, the deformities are constantly changing.
In addition, the serious lack of clinical diagnosis and treatment resources in the Department of Pediatric Orthopedics has led to the misdiagnosis and improper treatment of children's limb deformities.
Thus, its necessary to find an intelligent way to help doctor to early diagnosis of limb deformity and provide a proper treatment in children.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The extraction and application of big data of children's limb deformities, intelligent labeling of image data, precise positioning, and perfecting the anatomical data of children's limb deformities.Improve the positioning accuracy of key points in X-ray images of children's limb deformities by means of step-by-step supervision to improve the accuracy of diagnosis.Realize an intelligent report generation system that combines patient background information, establish an end-to-end auxiliary diagnosis and treatment suggestion demonstration application system; realize a full set of artificial intelligence solutions for children's skeletal deformities, early screening and diagnosis of children, and forming an intelligent referral system of children's limb deformities.
Study Type
Observational
Enrollment (Anticipated)
9000
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: Bo Ning, PhD
- Phone Number: +86 13585700275
- Email: ningbo@fudan.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
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children with limb deformity
Description
Inclusion Criteria:
Children with limb deformity
Exclusion Criteria:
Children without limb deformity
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 |
---|---|
limb deformity children
the imaging of limb deformity diagnosis by AI
|
It is an observational study.
No interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Deformity detection
Time Frame: At enrollment
|
It is a binary variable (1/0).
The radiographic features of children would be evaluated by artificial Intelligence.
If the deformity was detected, variable would be setted into 1.
|
At enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bo Ning, PhD, Children's Hospital of Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jamaludin A, Lootus M, Kadir T, Zisserman A, Urban J, Battie MC, Fairbank J, McCall I; Genodisc Consortium. ISSLS PRIZE IN BIOENGINEERING SCIENCE 2017: Automation of reading of radiological features from magnetic resonance images (MRIs) of the lumbar spine without human intervention is comparable with an expert radiologist. Eur Spine J. 2017 May;26(5):1374-1383. doi: 10.1007/s00586-017-4956-3. Epub 2017 Feb 6.
- Mirskaia NB, Kolomenskaia AN, Siniakina AD. [Prevalence and medical and social importance of disorders and diseases of the musculoskeletal systems in children and adolescents (review of literature)]. Gig Sanit. 2015 Jan-Feb;94(1):97-104. Russian.
- Theofilatos K, Pavlopoulou N, Papasavvas C, Likothanassis S, Dimitrakopoulos C, Georgopoulos E, Moschopoulos C, Mavroudi S. Predicting protein complexes from weighted protein-protein interaction graphs with a novel unsupervised methodology: Evolutionary enhanced Markov clustering. Artif Intell Med. 2015 Mar;63(3):181-9. doi: 10.1016/j.artmed.2014.12.012. Epub 2015 Feb 18.
- Silverman BG, Hanrahan N, Bharathy G, Gordon K, Johnson D. A systems approach to healthcare: agent-based modeling, community mental health, and population well-being. Artif Intell Med. 2015 Feb;63(2):61-71. doi: 10.1016/j.artmed.2014.08.006. Epub 2014 Sep 11.
- Ravi D, Wong C, Deligianni F, Berthelot M, Andreu-Perez J, Lo B, Yang GZ. Deep Learning for Health Informatics. IEEE J Biomed Health Inform. 2017 Jan;21(1):4-21. doi: 10.1109/JBHI.2016.2636665. Epub 2016 Dec 29.
- Rahmathulla G, Nottmeier EW, Pirris SM, Deen HG, Pichelmann MA. Intraoperative image-guided spinal navigation: technical pitfalls and their avoidance. Neurosurg Focus. 2014 Mar;36(3):E3. doi: 10.3171/2014.1.FOCUS13516.
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)
December 1, 2022
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
August 22, 2020
First Submitted That Met QC Criteria
August 22, 2020
First Posted (Actual)
August 26, 2020
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 10, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ningbo1528
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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