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

Aarhus University Hospital

Status: Enrolling

Conditions: Developmental Dysplasia of the Hip

Treatments: Diagnostic Test: Repeat hip ultrasound measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT06233487

1-49-72-4-18

Details and patient eligibility

About

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.

Full 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.

This study aims 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.

Enrollment: 110 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Double measurements

Other group

Description:

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

Treatment:

Diagnostic Test: Repeat hip ultrasound measurements