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

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.

NCT Number	NCT07488260
Lead Sponsor	Pentacomp Systemy Informatyczne S.A
Conditions	Developmental Dysplasia of the Hip (DDH)
Enrollment	150 participants
Start Date	2026-07
Primary Completion	2027-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-08