Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorPentacomp Systemy Informatyczne S.A
About this trial
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.
Eligibility criteria
Qualifiers
Participants whose Parent(s) or Legally Authorized Representative(s) have provided written informed consent;
Participants who need to undergo routine DDH screening and receive an ultrasound as part of the clinical investigation;
Participants of either sex aged between 4 weeks and 6 months weeks.
Disqualifiers
Participants with open wounds, ulcers, burns, viral or bacterial infections at the site intended for examination;
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;
Participants with history of trauma, surgical intervention, or post-traumatic/post-surgical condition in the area to be examined.
Trial design
Treatments tested in this trial
- AI-supported hip ultrasound analysis
Treatment groups
150 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov