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Efficacy Study of DeepDDH System in Screening Infants with Developmental Dysplasia of the Hip (DDH)

NCT06765525 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1976

Last updated 2025-01-09

No results posted yet for this 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.

Conditions

  • Hip Dysplasia, Developmental

Interventions

OTHER

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.

OTHER

Senior sonographer measurement of DDH

Participants will not receive visual cues from the DeepDDH system.

OTHER

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.

OTHER

AI-assisted junior sonographer meaturement of DDH

Participants will receive visual cues from the DeepDDH system.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-03-30
Completion
2025-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765525 on ClinicalTrials.gov