An interventional study of AI-supported hip ultrasound analysis in Developmental Dysplasia of the Hip (DDH), sponsored by Pentacomp Systemy Informatyczne S.A. Not yet recruiting. Open to participants aged 4 Weeks to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Pentacomp Systemy Informatyczne S.A · Not applicable, Interventional, and Diagnostic
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.
The purpose of this prospective, multicentre clinical investigation is to evaluate the effectiveness of the application in routine clinical settings, specifically by comparing the application-generated diagnostic results with those obtained from standard ultrasound examinations conducted by physicians.
The IMD (investigational medical device) was chosen for clinical evaluation because its AI algorithms have shown promising results in identifying key anatomical landmarks, justifying its transition from development to clinical investigation. This study has been designed based on comprehensive pre-clinical verification and validation data, including reliability, usability, and cybersecurity testing, to demonstrate the device's effectiveness in supporting clinicians during DDH assessment. Unlike traditional physical medical devices, the IMD is a digital solution composed of several integrated modules, including a Physician Portal, an AI diagnostic suite, and a Decision-Support Module. The potential indications for using AI-based diagnostic tools like the IMD are extensive in pediatric orthopedics. Such digital tools could increasingly be used to support the early identification of DDH, which affects approximately
1 in 100 infants. Early detection is critical, as late diagnosis could be associated with degenerative joint disease and the need for complex surgical interventions. In cases of routine screening, AI-based diagnostic tools are expected to help maintain the integrity of the diagnostic workflow by ensuring that only high-quality, standard-plane images are used for classification. In future clinical practice, AI-supported tools may meaningfully improve diagnostic quality and efficiency, potentially setting new standards for early intervention.
Within this framework, the IMD represents a new generation of diagnostic aids that enhance the benefits of ultrasound screening, especially for high-risk groups (female sex, breech presentation, or family history).
60 studies on the registry are indexed under Developmental Dysplasia of the Hip; 18 are open to participants now.
This study's planned enrollment of 150 is above the median of 59 across 38 interventional studies indexed under Developmental Dysplasia of the Hip.
Browse Developmental Dysplasia of the Hip studies →This is the only study on the registry with Pentacomp Systemy Informatyczne S.A as lead sponsor.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AI-supported analysis of hip ultrasound images (software application) compared with physician assessment using the Graf method.
Device: AI-supported hip ultrasound analysis
Software for supporting the diagnostic assessment of developmental dysplasia of the hip (DDH) in infants during pre-luxation visits
Also known as: Prelux
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
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Developmental Dysplasia of the Hip →