Clinical trial NCT06803004: Diagnostic Efficacy Study of AI System in Screening Infants with Developmental Dysplasia of the Hip
Official title: Blinded Randomized Control Trail of Artificial Intelligence-Assisted Ultrasound Screening for Neonatal Hip Dysplasia in a Clinical Cohort
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Dysplasia, Developmental
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 1976
Sex: ALL
Minimum age (years): 28
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average diagnostic accuracy
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Average diagnostic sensitivity
timeFrame: up to 4 weeks
measure: Average diagnostic specificity
timeFrame: up to 4 weeks
measure: Average times of follow-up visits
timeFrame: up to 4 weeks
measure: Diagnosis time
timeFrame: up to 4 weeks
measure: Bang's index
timeFrame: up to 4 weeks
measure: Frequency pediatrician adjusts preliminary annotation
timeFrame: up to 4 weeks
measure: Frequency pediatrician adjusts preliminary DDH type
timeFrame: up to 4 weeks
measure: Mean change in alpha angle between preliminary and final report
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: