Diagnostic Efficacy Study of AI System in Screening Infants With Developmental Dysplasia of the Hip
NCT ID: NCT06803004
Last Updated: 2025-08-28
Study Results
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Basic Information
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COMPLETED
NA
1789 participants
INTERVENTIONAL
2025-07-18
2025-08-20
Brief Summary
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Detailed Description
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The data in the ultrasound screening sequence database in this part of the study were mainly from Renji Hospital and the Sixth People's Hospital in Shanghai between August 2014 and December 2021. Renji Hospital, the Sixth People's Hospital, and the Pediatric Hospital Affiliated to Fudan University, three top-three hospitals in Shanghai, started Graf ultrasound examination earlier, with an average history of more than 10 years. And they are responsible for providing expert sonographers with more than 5-10 years of DDH ultrasound diagnosis experience, and pediatric orthopedic experts with 5-10 years of DDH diagnosis experience to participate in the study. However, several other primary or remote medical institutions with late DDH ultrasound screening and insufficient diagnostic experience were mainly responsible for providing primary sonographers to participate in the study. Before the study, the sonographers involved in this study will be evaluated uniformly and quantitatively through examination papers.
2. Research process:
One week before the start of the study, the sonographers registered in the study received uniform training of the latest DDH ultrasound diagnosis in the form of PPT, video, literature study, and offline instruction.
For the included cases in the ultrasound screening sequence database, they would appear in different control groups in a random form, such as the AI model, the Expert sonographer group, the primary sonographer group, and the primary sonographer with AI 'aid group. All cases in the ultrasound screening sequence database were stratified and block-randomized into the above four groups (primary, experts, AI-independent, AI-assisted primary).
In the AI-assisted group, each sonographer was asked to choose whether to modify or confirm the diagnosis according to the measurement marks, diagnostic angles and typing results provided by the AI device. However, in the Expert sonographer group and junior sonographer unassisted group, the dedicated research assistant will turn off the AI display function to ensure that no additional information is provided to the sonographer. The consensus of two pediatric orthopedic expert with 5-10 years of experience in DDH ultrasound diagnosis was used as the gold standard. In case of disagreement, a third pediatric expert will evaluate the diagnosis results of DDH. The final consensus was used as the gold standard.
Then, the pediatric orthopedic expert group were given the initial annotations diagnosis results of DDH in the above four groups, including diagnostic images, diagnostic measurement marks, diagnostic angles and diagnostic types. And by reviewing the initial annotations, selecting "confirm" or "modify" the initial annotations, the final annotations are made again for those who need to be modified, and the final report results are obtained.
Finally, the operation results of the above different groups were summarized and analyzed by independent research assistants, including α Angle, β Angle, typing results, and the specific follow-up experience of the case including follow-up times, diagnosis time, Bang's index, proportion of studies the annotation is changed, proportion of studies the DDH type is changed in final report, and mean change in alpha angle between preliminary and final report.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Junior Sonographer Annotation
Participants will not receive visual cues from the DeepDDH system. Junior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.
Junior sonographer measurement of DDH
Participants will not receive visual cues from the DeepDDH system. Junior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.
Senior Sonographer Annotation
Participants will not receive visual cues from the DeepDDH system. Senior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.
Senior sonographer measurement of DDH
Participants will not receive visual cues from the DeepDDH system. Senior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.
DeepDDH system Annotation
Through randomization, a subset of the preliminary interpretations will be conducted by AI technology, and the study team will evaluate the degree of divergence between these AI-generated preliminary interpretations and the final interpretations.
Automated annotation of the DDH measurement through deep learning
Through randomization, a subset of the preliminary interpretations will be conducted by AI technology, and the study team will evaluate the degree of divergence between these AI-generated preliminary interpretations and the final interpretations.
DeepDDH-assist Junior Sonographer Annotation
Participants will receive visual cues from the DeepDDH system.
AI-assisted junior sonographer measurement of DDH
Participants will receive visual cues from the DeepDDH system.
Interventions
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Junior sonographer measurement of DDH
Participants will not receive visual cues from the DeepDDH system. Junior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.
Senior sonographer measurement of DDH
Participants will not receive visual cues from the DeepDDH system. Senior sonographer technicians will offer preliminary interpretations before these are subjected to validation and subsequent review by expert's team.
Automated annotation of the DDH measurement through deep learning
Through randomization, a subset of the preliminary interpretations will be conducted by AI technology, and the study team will evaluate the degree of divergence between these AI-generated preliminary interpretations and the final interpretations.
AI-assisted junior sonographer measurement of DDH
Participants will receive visual cues from the DeepDDH system.
Eligibility Criteria
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Inclusion Criteria
* Infants aged 28 days to 6 months.
Exclusion Criteria
* Infants with poor image quality, including non-compliance with anatomical identification and usability check.
* Infants with hip dysplasia caused by other diseases.
28 Days
6 Months
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Lixin Jiang
Director of Department of ultrasound in medicine, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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LY2025-004-C
Identifier Type: -
Identifier Source: org_study_id
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