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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06233487
Other study ID # 1-49-72-4-18
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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