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CompletedNCT06233487Updated Feb 10, 2026

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

An interventional study of Repeat hip ultrasound measurements in Developmental Dysplasia of the Hip, sponsored by Aarhus University Hospital. Completed at 1 site in Denmark. Open to participants aged 0 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
0 Months to 6 Months
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Developmental Dysplasia of the Hip
03

In context

Developmental Dysplasia of the Hip

114 studies on the registry are indexed under Developmental Dysplasia of the Hip; 17 are open to participants now.

This study's enrollment of 74 is above the median of 61 across 71 interventional studies indexed under Developmental Dysplasia of the Hip.

Browse Developmental Dysplasia of the Hip studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Children deemed too agitated to participate in hip US with double measurements by two radiologists.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Other
    Double measurements

    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

  • Diagnostic testRepeat hip ultrasound measurements

    See earlier

06

What researchers measure

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.

    Time frame: Ultrasound measurements collected during the ultrasound examination by both radiologists

07

Study locations

1 site
  • Aarhus University Hospital
    Aarhus, 8200, Denmark
08

References and documents

Individual participant data

Plan to share: Yes — Study protocol, analysis plan, and analytic code will be available upon written request to the first author.

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06233487
Lead sponsor
Aarhus University Hospital
Collaborators
Aalborg University Hospital
Responsible party
Hans-Christen Husum (Postdoctoral Research Fellow, Department of Radiology, Principal Investigator, Aarhus University Hospital) — Principal investigator
First posted
Jan 31, 2024
Start date
Feb 27, 2024
Primary completion
Feb 7, 2026
Completion
Feb 7, 2026
Last update
Feb 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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