Diagnostic Efficacy Study of AI System in Screening Infants with Developmental Dysplasia of the Hip

Not Applicable

Not yet recruiting

• Conditions: Hip Dysplasia, Developmental

• Registration Number: NCT06803004
• Lead Sponsor: RenJi Hospital

Brief Summary

To ascertain the efficacy of the DeepDDH system, a deep learning framework, in enhancing diagnostic accuracy and curtailing follow-up intervals for infants undergoing screening for developmental dysplasia of the hip (DDH), the researchers are executing a blinded, randomized controlled trial. This trial juxtaposes AI-only and AI-assisted assessments of DDH against sonographer interpretations across various proficiency levels in the preliminary analysis of ultrasound images.

Detailed Description

1. Participating centers and doctors:

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study Start: 2025-01-30
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1976

Inclusion Criteria

• Infants underwent DDH ultrasound examinations.
• Infants aged 28 days to 6 months.

Exclusion Criteria

• Infants with lacking or incomplete ultrasound images.
• Infants with poor image quality, including non-compliance with anatomical identification and usability check.
• Infants with hip dysplasia caused by other diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average diagnostic accuracy	up to 4 weeks	It is calculated by dividing the number of preliminary interpretations that are consistent with the expert team's grading by the total number of cases that should be diagnosed.

Secondary Outcome Measures

Name	Time	Method
Average diagnostic sensitivity	up to 4 weeks	It is calculated by dividing the number of true positive cases by the sum of true positive cases and false negative cases.
Average diagnostic specificity	up to 4 weeks	It is calculated by dividing the number of true negative cases by the sum of true negative cases and false positive cases.
Average times of follow-up visits	up to 4 weeks	The average number of follow-up visits for each group is obtained by dividing the total number of follow-up visits for each participating infant within the group by the number of participating infants in that group.
Diagnosis time	up to 4 weeks	Time taken to make ultrasound diagnosis in each group
Bang's index	up to 4 weeks	Bang's index is used to evaluate whether the blind method is implemented successfully
Frequency pediatrician adjusts preliminary annotation	up to 4 weeks	Proportion of studies the annotation is changed
Frequency pediatrician adjusts preliminary DDH type	up to 4 weeks	Proportion of studies the DDH type is changed in final report
Mean change in alpha angle between preliminary and final report	up to 4 weeks	Average change in alpha angle between preliminary and final report

Trial Locations

Locations (1)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China