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
| Condition | Developmental Dysplasia of the Hip (DDH) |
| Intervention | AI-supported hip ultrasound analysis |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 150 |
| Est. Completion | 1 Jan 2027 |
| Last Updated | 8 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.
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