Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233487
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-23
Brief Title:
Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
In DDH diagnostics measurements of acetabular alpha angles and femoral head coverages FHC developed by Graf and HarckeTerjesen 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 Grafs alpha and beta angles the FHC and PFD in children referred for hip US in a selective ultrasound screening program for DDH
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 Grafs alpha and beta angles the FHC and PFD in children referred for hip US in a selective ultrasound screening program for DDH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None