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

Developmental Dysplasia of the Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233487
• Other study ID #: 1-49-72-4-18
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: Aarhus University Hospital
• Contact: Hans-Christen Husum, MD, PhD
• Phone: +4528891539
• Email: h.husum[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In DDH diagnostics, measurements of acetabular alpha angles and femoral head coverages (FHC), developed by Graf and Harcke/Terjesen respectively, have been gold standard since the 1980s. Despite their widespread use, the reliability of these measurements has been questioned due to the relative complexity of acquiring the necessary corIDrect frontal 2D plane or "standard plane". In the only meta-analysis of the reliability of ultrasound (US) metrics in dysplasia, the interrater reliability of the alpha angles was mediocre while the reliability of the FHC was poor. Critics of these findings however argue that the low reliability reported in studies are due to misinterpretation and misapplication of the Graf method.

The pubo-femoral distance (PFD) was proposed in 2013 as a new measurement for assessing DDH, while the reliability is reportedly higher than the gold standard US methods, it has never been directly compared to these.

We aim to evaluate the inter- and intrarater reliability of Graf's alpha and beta angles, the FHC and PFD in children referred for hip US in a selective ultrasound screening program for DDH.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: November 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Months to 6 Months

Eligibility

Inclusion Criteria:

• Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.

• Children receiving follow-up ultrasound for previously diagnosed DDH

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital

Intervention

Diagnostic Test:
• Repeat hip ultrasound measurements
See earlier

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	Aalborg University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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