Assessing AI-enhanced portable ultrasound screening for infant hip dysplasia

Phase 1

• Conditions: Diagnostic screening for developmental dysplasia of the hip (DDH) in infants; Musculoskeletal Diseases

• Registration Number: ISRCTN33985096
• Lead Sponsor: niversity of Alberta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-23
• Last Update Posted: 5 August 2024
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

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

Exclusion Criteria

Does not meet the inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)<br>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.