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Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip
Sponsor: Pentacomp Systemy Informatyczne S.A
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
Conditions
Interventions
AI-supported hip ultrasound analysis
Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits