Using Artificial Intelligence to Screen for Hip Dysplasia

NCT06647225 | Recruiting FDA Device

• 1 other identifier: 107227
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Developmental Dysplasia of Hip

Keywords

hip dysplasia; artificial intelligence; ultrasound; screening; infants

Outcome Measures

Primary Outcomes (4)

• Artificial Intelligence augmented ultrasound screening test capability: Sensitivity

  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

  1 day, both ultrasound scans will be performed on the same day

• Artificial Intelligence augmented ultrasound screening test capability: Specificity

  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

  1 day, both ultrasound scans will be performed on the same day

• Artificial Intelligence augmented ultrasound screening test capability: Positive predictive value (PPV)

  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

  1 day, both ultrasound scans will be performed on the same day

• Artificial Intelligence augmented ultrasound screening test capability: Negative predictive value (NPV)

  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

  1 day, both ultrasound scans will be performed on the same day

Secondary Outcomes (9)

• Factors associated with differences in device sensitivity

  1 day, all data will be collected from day of scan

• Factors associated with differences in device specificity

  1 day, all data will be collected from day of scan

• Factors associated with differences in device positive predictive value

  1 day, all data will be collected from day of scan

• Factors associated with differences in device negative predictive value

  1 day, all data will be collected from day of scan

• Device operator reliability in performing successful scans

  12 months or entire study duration

Study Arms (1)

All active participants

OTHER

All participants will undergo an AI-augmented ultrasound and there will be no active comparator

Device: Artificial intelligence augmented ultrasound

Interventions

Artificial intelligence augmented ultrasound DEVICE

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.

All active participants

Eligibility Criteria

• Age: 4 Weeks - 20 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Participants will be excluded from enrolment if:
• They are currently receiving treatment for DDH

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Leo T Donnan

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie K Hyde, BBiomedSc (Hons), PhD

CONTACT

61 3 9936 6246; natalie.hyde@mcri.edu.au

Melissa Formosa

CONTACT

melissa.formosa@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: As this is a single arm study no-one will be masked from intervention, however sonographers performing the standard ultrasound and participants will be masked from the results of the AI-ultrasound scan
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo the artificial intelligence ultrasound measures in addition to standard care.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 17, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

AU (1)