Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study

NCT06233487 | Completed

• 1 other identifier: 1-49-72-4-18
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Several measurements are used to evaluate hip dysplasia in hip ultrasound of children. Despite having being used since the 1980s, reliability studies have failed to find acceptable reliaiblity values for the gold standard ultrasound methods. This study will evaluate three ultrasound measurement methodologies in a high quality controlled setting, to investigate the best achieveable reliability and agreement of the investigated measurements used in hip dysplasia diagnostics.

Conditions

Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (1)

• Reliability and agreement in Alpha/Beta angles, Femoral head coverage and Pubo-femoral distance

  For all included ultrasound measurement methods the following will be reported: Inter- and intrarater reliability will be evaluated using the intraclass correlation coefficient (ICC) and interpreted with ICC values between 0-0.5, 0.5-0.75, 0.75-0.9 and above 0.9 indicating poor, moderate, good and excellent reliability respectively. Agreement will be evaluated using Bland-Altman plots (to check for systematic bias) and mean absolute measurement differences between raters.

  Ultrasound measurements collected during the ultrasound examination by both radiologists

Study Arms (1)

Double measurements

OTHER

All included children will have double measurements of the investigated ultrasound methodologies performed by two separate musculoskeletal radiologists.

Diagnostic Test: Repeat hip ultrasound measurements

Interventions

Repeat hip ultrasound measurements DIAGNOSTIC_TEST

See earlier

Double measurements

Eligibility Criteria

• Age: 0 Months - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.
• Children receiving follow-up ultrasound for previously diagnosed DDH

You may not qualify if:

• Children deemed too agitated to participate in hip US with double measurements by two radiologists.

Sponsors & Collaborators

• Aalborg University Hospital: collaborator
• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiologist will be blinded to each others measurements, until all examinations have been performed.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow, Department of Radiology, Principal Investigator

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: February 27, 2024
• Primary Completion: February 7, 2026
• Study Completion: February 7, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After study has been published (expected end 2024)
• Access Criteria: upon written request to the first author.

Locations

DK (1)