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NCT07488260
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Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip

Sponsor: Pentacomp Systemy Informatyczne S.A

View on ClinicalTrials.gov

Summary

The goal of this prospective, multicentre clinical investigation is to evaluate whether an artificial intelligence (AI)-supported software application can assist clinicians in the diagnostic assessment of developmental dysplasia of the hip (DDH) during routine ultrasound screening in infants. The main questions it aims to answer are: Does the diagnostic classification generated by the application agree with the classification obtained by physicians using standard ultrasound examination according to the Graf method? Can the application reliably identify key anatomical landmarks and angles required for DDH assessment? Researchers will compare the AI-generated diagnostic results with those obtained from standard ultrasound examinations performed by physicians to evaluate the level of agreement between the two approaches. Participants will: undergo a routine hip ultrasound examination performed by a physician according to the Graf method, have ultrasound images analyzed by the application, have the AI-generated results compared with the physician's assessment.

Official title: Evaluation of the Concordance Between the Software Application and Standard Ultrasound Assessment in Classifying Hip Types in Infants Screened for Developmental Dysplasia of the Hip (DDH)

Key Details

Gender

All

Age Range

4 Weeks - 6 Months

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-07

Completion Date

2027-01

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

DEVICE

AI-supported hip ultrasound analysis

Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits