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Clinical Trials in China / NCT06765525
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Efficacy Study of DeepDDH System in Screening Infants with Developmental Dysplasia of the Hip (DDH)

NCT06765525 · tracked via the Priya Life Science China tracker
Sponsor
RenJi Hospital
Phase
Not applicable
Started
2025-01-15
Last updated
2025-01-09

Condition(s) studied

Hip Dysplasia, Developmental

Investigational drug(s) / intervention(s)

Junior sonographer measurement of DDHSenior sonographer measurement of DDHAutomated annotation of the DDH measurement through deep learningAI-assisted junior sonographer meaturement of DDH

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.

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 meaturement of DDH: Participants will receive visual cues from the DeepDDH system.

Study 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.

Eligibility

Sex
ALL
Min age
28 Days
Max age
6 Months
Healthy volunteers
No
Inclusion Criteria: * Infants aged 28 days to 6 months who underwent DDH ultrasound examination in Renji Hospital, Shanghai Jiaotong University School of Medicine and the Sixth People's Hospital, Shanghai Jiaotong University School of Medicine between August 2014 and December 2021 Exclusion Criteria: * Patients lacking or incomplete ultrasound images; * Patients with poor image quality and unusable images after assessment, including non-compliance with Anatomical identification (Checklist I consists of seven anatomical structures: 1. Chondro-osseous border, 2. Femoral head, 3. Synovial fold, 4. Joint capsule and perichondrium, 5. Labrum, 6. Cartilagineous roof, 7. Bony roof) and Usability check (Checklist II includes three anatomical landmarks: 1. Lower limb of the os ilium, 2. Parallel middle plane, and 3. Labrum); * Infants with hip dysplasia caused by other diseases such as cerebral palsy, joint contracture, suppurative coxitis, etc., or with other hip diseases and limb deformities.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality

More RenJi Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06765525 on ClinicalTrials.gov ↗ ← All trials in China