Assessing AI-enhanced portable ultrasound screening for infant hip dysplasia

Assessment of developmental dysplasia of the hip screening in infants by AI-enhanced 3D point-of-care ultrasound: correlation with clinical and imaging findings at initial infant screening and follow-up

Status

Recruiting

Phases

Phase 1

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN33985096

Enrollment

20000

Registered

2024-07-23

Start date

2020-01-01

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic screening for developmental dysplasia of the hip (DDH) in infants Musculoskeletal Diseases

Interventions

Participants undergo initial screening for developmental dysplasia of the hip (DDH) using AI-enhanced 3D ultrasound (by 3D probe and/or cine sweep) at well-baby checkups (6-10 weeks old). All data col

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All infants in Alberta that can be reached with the technology 2. Age range from newborn to 12 weeks

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of DDH screening (using the US/AI model) against gold-standard conventional clinical ultrasound diagnosis, as assessed by sensitivity, specificity, positive and negative predictive value and AUC at the time of baseline ultrasound	—

Secondary

Measure	Time frame
1. Implementation success, assessed using the Consolidated Framework for Implementation Research (CFIR) 5-point framework, measured starting at initial rollout (2021), and every 3 years thereafter until the conclusion of recruitment (2024, 2027, 2030) 2. Feasibility of DDH screening (using the US/AI model) in neonates vs conventional physical assessments conducted by a physician at baseline, assessed by.System Usability Score (SUS), qualitative analysis of user and patient/family feedback from semi-structured interviews, and economic analysis. This is assessed every 3 years as above, based on data collected continuously and reviewed annually.	—

Measure

Time frame

1. Implementation success, assessed using the Consolidated Framework for Implementation Research (CFIR) 5-point framework, measured starting at initial rollout (2021), and every 3 years thereafter until the conclusion of recruitment (2024, 2027, 2030) 2. Feasibility of DDH screening (using the US/AI model) in neonates vs conventional physical assessments conducted by a physician at baseline, assessed by.System Usability Score (SUS), qualitative analysis of user and patient/family feedback from semi-structured interviews, and economic analysis. This is assessed every 3 years as above, based on data collected continuously and reviewed annually.

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Countries

Canada

Contacts

Public ContactCassandra Gallant

cgallan1@ualberta.ca+1 (0)780 493 2773

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026