Artificial intelligence augmented ultrasound: The hip ultrasound is performed using a handheld device (Exo Iris) that uses a pocket-sized ultrasound probe and is run through an application on an IoS (Apple mobile) operation system. . A real-time algorithm detects and records the anatomical landmarks. When there are enough images for analysis the operator is notified that the scan is complete.
Study summary
The goal of this clinical trial is to learn if an ultrasound scan using artificial intelligence can accurately screen for hip dysplasia. Researchers will compare the artificial intelligence ultrasound results to the standard ultrasound measures to see if the artificial intelligence ultrasound scan can accurately screen for hip dysplasia.
It will also seek to understand how parents feel about their children undergoing this scan.
Participants will:
* Have an additional ultrasound performed on their child at their scheduled outpatient's appointment for hip dysplasia
* Complete a short questionnaire about the experience of having the measurement performed on their child
Eligibility
Sex
ALL
Min age
4 Weeks
Max age
20 Weeks
Healthy volunteers
Accepted
Inclusion Criteria:
* Enrolled in the VicHip study
* Is 4-20 weeks of age at enrolment
* Is attending The Royal Children's Hospital for the purpose of the potential diagnosis of DDH
* Has a diagnostic (standard) hip ultrasound on the day of their out-patient appointment
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion Criteria:
Participants will be excluded from enrolment if:
• They are currently receiving treatment for DDH
Primary outcome measure(s)
Artificial Intelligence augmented ultrasound screening test capability: Sensitivity — 1 day, both ultrasound scans will be performed on the same day Artificial intelligence (AI) augmented ultrasound results will be compared to standard ultrasound imaging to calculate sensitivity (\[number of true positive cases detected/(number of true positive cases detected + number of false negative cases detected)\] X 100). Groups will be defined as follows:
* True positive cases: Flagged for follow-up after the AI assessment of ultrasound sweeps from the portable probe and have a diagnosis of DDH from traditional ultrasound reports.
* False positive cases: Flagged for follow-up after the AI assessment of the ultrasound sweeps and do not have a diagnosis of DDH from the traditional ultrasound reports
* False negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and have a diagnosis of DDH from traditional ultrasound reports
* True negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and do not have a diagnosis of DDH from traditional ultrasound reports
Artificial Intelligence augmented ultrasound screening test capability: Specificity — 1 day, both ultrasound scans will be performed on the same day Artificial intelligence (AI) augmented ultrasound results will be compared to standard ultrasound imaging to calculate specificity (\[number of true negative cases detected/(number of false positive cases detected + number of true negatives cases detected\] X 100). Groups will be defined as follows:
* True positive cases: Flagged for follow-up after the AI assessment of ultrasound sweeps from the portable probe and have a diagnosis of DDH from traditional ultrasound reports.
* False positive cases: Flagged for follow-up after the AI assessment of the ultrasound sweeps and do not have a diagnosis of DDH from the traditional ultrasound reports
* False negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and have a diagnosis of DDH from traditional ultrasound reports
* True negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and do not have a diagnosis of DDH from traditional ultrasound reports
Artificial Intelligence augmented ultrasound screening test capability: Positive predictive value (PPV) — 1 day, both ultrasound scans will be performed on the same day Artificial intelligence (AI) augmented ultrasound will be compared to standard ultrasound to calculate PPV (\[number of true positive cases detected/(number of true positive cases detected + number of false positive cases predicted) X 100). Groups will be defined as follows:
* True positive cases: Flagged for follow-up after the AI assessment of ultrasound sweeps from the portable probe and have a diagnosis of DDH from traditional ultrasound reports.
* False positive cases: Flagged for follow-up after the AI assessment of the ultrasound sweeps and do not have a diagnosis of DDH from the traditional ultrasound reports
* False negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and have a diagnosis of DDH from traditional ultrasound reports
* True negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and do not have a diagnosis of DDH from traditional ultrasound reports
Artificial Intelligence augmented ultrasound screening test capability: Negative predictive value (NPV) — 1 day, both ultrasound scans will be performed on the same day Artificial intelligence (AI) augmented ultrasound will be compared to standard ultrasound to calculate NPV \[number of true negative cases detected/(number of false negatives detected + number of true negative cases detected) X 100. Groups will be defined as follows:
* True positive cases: Flagged for follow-up after the AI assessment of ultrasound sweeps from the portable probe and have a diagnosis of DDH from traditional ultrasound reports.
* False positive cases: Flagged for follow-up after the AI assessment of the ultrasound sweeps and do not have a diagnosis of DDH from the traditional ultrasound reports
* False negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and have a diagnosis of DDH from traditional ultrasound reports
* True negative cases: Return a "normal hips" assessment after the AI assessment of the ultrasound probe and do not have a diagnosis of DDH from traditional ultrasound reports
Trial sites (1)
Facility
City
Region
Status
Royal Children's Hospital
Parkville
Victoria
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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