Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip (NCT07488260) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of a Software Application for Assessment of Developmental Dysplasia of the Hip
150 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
4 Weeks – 6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic agreement rate between the software application and the standard ultrasound assessment conducted by physicians