Developmental Dysplasia of HipNCT07066852
Evaluation of the Effectiveness of Developmental Hip Dysplasia Screening in Risk Groups
An observational study of Developmental Dysplasia of Hip, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study is a non-drug clinical trial. Developmental dysplasia of the hip (DDH) encompasses a spectrum of hip developmental disorders, including dislocation, subluxation, and acetabular dysplasia. DDH is among the most prevalent hip conditions in infants. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Developmental Dysplasia of Hip
- What is being tested?
- x ray and ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Nov 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will include all children born in the high-risk pregnancy service at our hospital. Participants will be selected randomly, and their families will be informed about the study, providing consent for participation. The study aims to evaluate the effectiveness of developmental hip dysplasia (DDH) screening in high-risk groups in Turkey. Hip ultrasound will be performed six weeks after birth using the Graf method for screening purposes. This examination will include the Ortolani-Barlow test, Galeazzi sign, swaddling, and assessment of any accompanying foot deformities. All ultrasounds will be conducted by a single physician. If any pathology is detected, treatment will be initiated according to current literature. Follow-up evaluations will be conducted at three months, six months, and one year to monitor hip development and assess the acetabular index using Tönnis grading and abduction limitation.
Who may be able to join
- All girls and boys of Turkish origin born in our hospital were included in our study.
Who cannot join
- Teratological hip diseases with neuromuscular disorders were excluded from our study. Parents who disrupted follow-up were excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara
Ankara, Ankara, 06340
About this study
This study is a non-drug clinical trial.
Developmental dysplasia of the hip (DDH) encompasses a spectrum of hip developmental disorders, including dislocation, subluxation, and acetabular dysplasia. DDH is among the most prevalent hip conditions in infants. Dislocation is defined as the incomplete displacement of the hip joint, and residual dislocation due to DDH is associated with pain and severe osteoarthritis of the hip in young adulthood.
Read more
The progression of DDH is dynamic and may improve or worsen depending on various factors. The primary determinant of prognosis is the concentric reduction of the hip joint, with the femoral head needing to be reduced to allow for normal acetabular development.
DDH is the most common orthopedic condition in the neonatal period. According to the literature, the incidence is approximately 1:100 for dysplasia and 1:1000 for dislocation. However, estimates suggest that dislocation rates in Türkiye may reach 5-15:1000. DDH occurs six times more frequently in girls than boys and is more commonly observed in the left hip. Established risk factors for DDH include being a first-born girl, Caucasian race, positive family history, oligohydramnios, multiple pregnancies, in utero breech presentation, pes calcaneovalgus, metatarsus adductus, and torticollis.
Early detection and treatment of dislocation caused by DDH are associated with success rates exceeding 80%. However, diagnosis and treatment initiation after one year of age often result in variable outcomes. Literature indicates that clinical and sonographic evaluations may be normal at six weeks in breech patients-who are at significant risk for DDH-yet hip dysplasia may still develop in this population later. The investigators aim to contribute to existing literature by evaluating whether sonographic screening alone is sufficient or if additional screening methods are warranted for patients with identified DDH risk factors.
Read the detailed description
Study Overview This study aims to evaluate the effectiveness of developmental dysplasia of the hip (DDH) screening in high-risk pediatric groups in Türkiye.
In Türkiye, all newborns undergo routine hip ultrasonography during the second month of life. If the results are normal, no further hip evaluations are typically performed. However, incidental detection of acetabular dysplasia in children-who later undergo pelvic anteroposterior (AP) X-rays for unrelated reasons-has raised concerns regarding the sufficiency of current screening protocols. Recent studies emphasize that hip development is a dynamic process, with the first 18 months being critical for early intervention. The timely detection of hip dysplasia is essential to minimize long-term physical and psychological burden on patients and healthcare systems. Undiagnosed cases often result in the need for total hip replacement surgery in adulthood. Accordingly, there is a need for a large-scale, prospective study to broaden and enhance the scope of DDH screening, both nationally and globally.
Study Population and Screening Protocol Participants will include all children born in the high-risk pregnancy ward at Ankara Bilkent City Hospital, selected via randomized sampling. After obtaining informed consent from families, hip ultrasonography will be performed six weeks postpartum using the Graf classification method. The screening will include Ortolani-Barlow maneuvers, Galeazzi sign assessment, swaddling practices, and evaluation of associated foot deformities. All sonographic assessments will be conducted by a single, qualified physician.
In cases where pathology is detected, treatment will be initiated in accordance with current medical guidelines. The Graf-based ultrasonography will be repeated at the third month, and follow-up clinical notes will be documented. At six months of age, pelvic AP and frog-leg lateral X-rays will be obtained. The acetabular index will be assessed using the Tönnis grading system, and any limitations in abduction will be recorded. At one year of age, follow-up X-rays will be performed to reassess the acetabular index and Tönnis grade, facilitating longitudinal monitoring of hip development during infancy.
Ethics and Statistical Evaluation Ethics approval for this study was granted by the Ethics Committee of Ankara Bilkent City Hospital (Board No. 1). Power analysis indicated a required sample size of 185 participants to achieve a statistical power of 0.95. This study will be conducted prospectively and analyzed using SPSS version 26.0. Findings will be reported to the Ministry of Health of Türkiye upon study completion.
- Conditions
- Developmental Dysplasia of Hip
- Being tested
- x ray, ultrasound
- Keywords
- acetabulardysplasia, screening, ultrasound, xray, developmentaldysplasiaofhip, PediatricOrthopedics
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x rayRadiation
we performed pelvis ap and frog leg x ray to child in 6 month and 1 age
ultrasoundDiagnostic test
we will perform ultrasound in 6 week and 3 month
| Study group | Role | What they receive |
|---|---|---|
| sample | we use one arm and one sample Receives: Radiation: x ray; Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetabular Index Variation Measured by Tönnis Grading System
The change in acetabular index will be assessed using pelvic anteroposterior(AP) and frog-leg lateral x-rays. Measurements will be analyzed according to the classification system. The unit of measure will be degrees(°).
Measured: At 6 months and 1 year of age
Secondary outcomes (1)
Incidence of Pathological Findings on Graf Ultrasonography
Rate of infants showing sonographic abnormalities(types 2b,2c,d,3,4) on graf uulrasound.Assessment will indclude morphological classification using Graf's criteria.Unit of measure:% of screened participants.
Measured: At 6 weeks and 3 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dysplasia of HipStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KENAN ŞEN, Ankara City Hospital Bilkent
- Investigators
- Mehmet Safa Kapıcıoğlu, Proffesor, Study director, Department of Orthopedics and Traumatology, Bilkent City Hospital, AnkaraMehmet Safa Kapıcıoğlu, Proffesor, Principal investigator, Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066852
- Sponsor's protocol ID
- DDHBilkent
- Status last verified
- Sep 2025
- First submitted
- 12 Nov 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I plan to share the code with famous journals as proof that I have done a prospective study. In addition, since this study means 1-year hip follow-up of 340 children and there is no follow-up of this size, I want it for proof purposes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Developmental Hip Dysplasia Screening in Risk Groups
- ClinicalTrials.gov ID
- NCT07066852
- Acronym / sponsor ID
- DDHBilkent
- Conditions
- Developmental Dysplasia of Hip
- Keywords
- acetabulardysplasia, screening, ultrasound, xray, developmentaldysplasiaofhip, PediatricOrthopedics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 Jul 2025 (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.
This study is a non-drug clinical trial.
Developmental dysplasia of the hip (DDH) encompasses a spectrum of hip developmental disorders, including dislocation, subluxation, and acetabular dysplasia. DDH is among the most prevalent hip conditions in infants. Dislocation is defined as the incomplete displacement of the hip joint, and residual dislocation due to DDH is associated with pain and severe osteoarthritis of the hip in young adulthood.
The progression of DDH is dynamic and may improve or worsen depending on various factors. The primary determinant of prognosis is the concentric reduction of the hip joint, with the femoral head needing to be reduced to allow for normal acetabular development.
DDH is the most common orthopedic condition in the neonatal period. According to the literature, the incidence is approximately 1:100 for dysplasia and 1:1000 for dislocation. However, estimates suggest that dislocation rates in Türkiye may reach 5-15:1000. DDH occurs six times more frequently in girls than boys and is more commonly observed in the left hip. Established risk factors for DDH include being a first-born girl, Caucasian race, positive family history, oligohydramnios, multiple pregnancies, in utero breech presentation, pes calcaneovalgus, metatarsus adductus, and torticollis.
Early detection and treatment of dislocation caused by DDH are associated with success rates exceeding 80%. However, diagnosis and treatment initiation after one year of age often result in variable outcomes. Literature indicates that clinical and sonographic evaluations may be normal at six weeks in breech patients-who are at significant risk for DDH-yet hip dysplasia may still develop in this population later. The investigators aim to contribute to existing literature by evaluating whether sonographic screening alone is sufficient or if additional screening methods are warranted for patients with identified DDH risk factors.
Detailed description
Study Overview This study aims to evaluate the effectiveness of developmental dysplasia of the hip (DDH) screening in high-risk pediatric groups in Türkiye.
In Türkiye, all newborns undergo routine hip ultrasonography during the second month of life. If the results are normal, no further hip evaluations are typically performed. However, incidental detection of acetabular dysplasia in children-who later undergo pelvic anteroposterior (AP) X-rays for unrelated reasons-has raised concerns regarding the sufficiency of current screening protocols. Recent studies emphasize that hip development is a dynamic process, with the first 18 months being critical for early intervention. The timely detection of hip dysplasia is essential to minimize long-term physical and psychological burden on patients and healthcare systems. Undiagnosed cases often result in the need for total hip replacement surgery in adulthood. Accordingly, there is a need for a large-scale, prospective study to broaden and enhance the scope of DDH screening, both nationally and globally.
Study Population and Screening Protocol Participants will include all children born in the high-risk pregnancy ward at Ankara Bilkent City Hospital, selected via randomized sampling. After obtaining informed consent from families, hip ultrasonography will be performed six weeks postpartum using the Graf classification method. The screening will include Ortolani-Barlow maneuvers, Galeazzi sign assessment, swaddling practices, and evaluation of associated foot deformities. All sonographic assessments will be conducted by a single, qualified physician.
In cases where pathology is detected, treatment will be initiated in accordance with current medical guidelines. The Graf-based ultrasonography will be repeated at the third month, and follow-up clinical notes will be documented. At six months of age, pelvic AP and frog-leg lateral X-rays will be obtained. The acetabular index will be assessed using the Tönnis grading system, and any limitations in abduction will be recorded. At one year of age, follow-up X-rays will be performed to reassess the acetabular index and Tönnis grade, facilitating longitudinal monitoring of hip development during infancy.
Ethics and Statistical Evaluation Ethics approval for this study was granted by the Ethics Committee of Ankara Bilkent City Hospital (Board No. 1). Power analysis indicated a required sample size of 185 participants to achieve a statistical power of 0.95. This study will be conducted prospectively and analyzed using SPSS version 26.0. Findings will be reported to the Ministry of Health of Türkiye upon study completion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sample | – | Radiation: x ray, Diagnostic Test: ultrasoundwe use one arm and one sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include all children born in the high-risk pregnancy service at our hospital. Participants will be selected randomly, and their families will be informed about the study, providing consent for participation. The study aims to evaluate the effectiveness of developmental hip dysplasia (DDH) screening in high-risk groups in Turkey. Hip ultrasound will be performed six weeks after birth using the Graf method for screening purposes. This examination will include the Ortolani-Barlow test, Galeazzi sign, swaddling, and assessment of any accompanying foot deformities. All ultrasounds will be conducted by a single physician. If any pathology is detected, treatment will be initiated according to current literature. Follow-up evaluations will be conducted at three months, six months, and one year to monitor hip development and assess the acetabular index using Tönnis grading and abduction limitation.
Key inclusion criteria (1 listed)
- All girls and boys of Turkish origin born in our hospital were included in our study.
Key exclusion criteria (1 listed)
- Teratological hip diseases with neuromuscular disorders were excluded from our study. Parents who disrupted follow-up were excluded from the study.
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 |
|---|---|---|
| x raywe performed pelvis ap and frog leg x ray to child in 6 month and 1 age | Radiation | sample |
| ultrasoundwe will perform ultrasound in 6 week and 3 month | Diagnostic test | sample |
Primary outcome
Acetabular Index Variation Measured by Tönnis Grading System
Time frame: At 6 months and 1 year of age
The change in acetabular index will be assessed using pelvic anteroposterior(AP) and frog-leg lateral x-rays. Measurements will be analyzed according to the classification system. The unit of measure will be degrees(°).
1 secondary outcome
Incidence of Pathological Findings on Graf Ultrasonography
Time frame: At 6 weeks and 3 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: Yes. I plan to share the code with famous journals as proof that I have done a prospective study. In addition, since this study means 1-year hip follow-up of 340 children and there is no follow-up of this size, I want it for proof purposes
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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.
Mehmet Safa Kapıcıoğlu, Proffesor study director
Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara
Mehmet Safa Kapıcıoğlu, Proffesor principal investigator
Department of Orthopedics and Traumatology, Bilkent City Hospital, Ankara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dysplasia of Hip, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 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: enrolling by invitation, as of the sponsor's last update on 18 Sep 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
Acetabular Index Variation Measured by Tönnis Grading System (time frame: At 6 months and 1 year of age). 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 18 Sep 2025.