Developmental Dysplasia of the HipNCT06233487
Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
A study testing Repeat hip ultrasound measurements in people with Developmental Dysplasia of the Hip, run by Aarhus University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 0 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of the Hip
- What is being tested?
- Repeat hip ultrasound measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Feb 2024to 7 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.
- Children receiving follow-up ultrasound for previously diagnosed DDH
Who cannot join
- Children deemed too agitated to participate in hip US with double measurements by two radiologists.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Developmental Dysplasia of the Hip
- Being tested
- Repeat hip ultrasound measurements
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeat hip ultrasound measurementsDiagnostic test
See earlier
| Study group | Role | What they receive |
|---|---|---|
| Double measurements | Other | All included children will have double measurements of the investigated ultrasound methodologies performed by two separate musculoskeletal radiologists. Receives: Diagnostic Test: Repeat hip ultrasound measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Ultrasound measurements collected during the ultrasound examination by both radiologists
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start27 Feb 2024
- Primary completion7 Feb 2026
- Study completion7 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital
- Responsible party
- Principal investigator, Hans-Christen Husum, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233487
- Sponsor's protocol ID
- 1-49-72-4-18
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, analysis plan, and analytic code will be available upon written request to the first author.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Ultrasound Metrics Used in Hip Dysplasia Diagnostics - a Prospective Study
- ClinicalTrials.gov ID
- NCT06233487
- Acronym / sponsor ID
- 1-49-72-4-18
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- 7 Feb 2026 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double measurements | Other | Diagnostic Test: Repeat hip ultrasound measurementsAll included children will have double measurements of the investigated ultrasound methodologies performed by two separate musculoskeletal radiologists. |
Who may qualify
- Ages
- 0 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children referred to the radiological outpatient at AUH for hip ultrasound examination, suspect of DDH.
- Children receiving follow-up ultrasound for previously diagnosed DDH
Key exclusion criteria (1 listed)
- Children deemed too agitated to participate in hip US with double measurements by two radiologists.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeat hip ultrasound measurementsSee earlier | Diagnostic test | Double measurements |
Primary outcome
Reliability and agreement in Alpha/Beta angles, Femoral head coverage and Pubo-femoral distance
Time frame: Ultrasound measurements collected during the ultrasound examination by both radiologists
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. Study protocol, analysis plan, and analytic code will be available upon written request to the first author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeat hip ultrasound measurements in people with Developmental Dysplasia of the Hip, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability and agreement in Alpha/Beta angles, Femoral head coverage and Pubo-femoral distance (time frame: Ultrasound measurements collected during the ultrasound examination by both radiologists). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.