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

ConditionDevelopmental Dysplasia of the Hip (DDH)

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

AI-supported hip ultrasound analysis
Device
Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits

Treatment groups

150 Participants

are divided into 1 treatment group

Group A: Ultrasound Assessment with AI-Supported AnalysisOther 1 intervention

Trial outcomes

Primary outcomes

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

The proportion of cases in which the classification generated by the application exactly matches the classification determined by the physicians

Time frame

Day 0

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pentacomp Systemy Informatyczne S.A

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: