Not_yet_recruitingNANCT07488260

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)

Sponsor: Pentacomp Systemy Informatyczne S.A

Trial Details

ConditionDevelopmental Dysplasia of the Hip (DDH)
InterventionAI-supported hip ultrasound analysis
PhaseNA
StatusNot_yet_recruiting
Participants150
Est. Completion1 Jan 2027
Last Updated8 Apr 2026

Primary Outcome

Diagnostic agreement rate between the software application and the standard ultrasound assessment conducted by physicians

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Participants whose Parent(s) or Legally Authorized Representative(s) have provided written informed consent; 2. Participants who need to undergo routine DDH screening and receive an ultrasound as part of the clinical investigation; 3. Participants of either sex aged between 4 weeks and 6 months weeks. Exclusion Criteria: 1. Participants with open wounds, ulcers, burns, viral or bacterial infections at the site intended for examination; 2. Participants with significant anatomical abnormalities (e.g. cerebral palsy, joint contracture, suppurative coxitis, other hip or limb deformities, or teratological hip dysplasia) that may affect the feasibility or accuracy of the examination; 3. Participants with history of trauma, surgical intervention, or post-traumatic/post-surgical condition in the area to be examined.

View Registry Entry

This content is for educational purposes for healthcare professionals only and does not constitute clinical advice. Clinical decisions should be based on individual patient assessment, current guidelines, and appropriate specialist consultation. Editorial Standards · Privacy Policy · Terms of Service