Developmental Dysplasia of the HipNCT05853510
Mid-term Functional Comparisons of Unilateral and Bilateral Developmental Dysplasia of the Hip
An observational study of Developmental Dysplasia of the Hip, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Developmental Dysplasia of the Hip
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2021to 11 Sep 2022
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who were treated with hip abduction brace in the orthopedics and traumatology department of a university hospital from January 2010 to January 2016 were screened from the hospital registry system. Eligible 72 patients were contacted by telephone and invited to participate in the present study and 54 patients agreed to participate. A total of 35 patients were able to complete all assessments and their data were analyzed. 16 patients had unilateral and 19 patients had bilateral developmental dysplasia of the hip.
Who may be able to join
- diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace
Who cannot join
- teratological hip dislocations,
- hip avascular necrosis,
- comorbid disease such as cerebral palsy, myelomeningocele, hypoxic encephalopathy, muscular dystrophy and leukoencephalopathy,
- receiving different treatments before.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Mid-term Functional Outcomes Different in Unilateral and Bilateral Developmental Dysplasia of the Hip? A Cross-sectional Study
The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. The implementation of the National DDH Early Diagnosis and Treatment Program by the Türkiye Republic of the Ministry of Health in 2010 significantly reduced the number of patients with DDH diagnosed more than 6 months later. If not appropriately treated, DDH can cause a decrease in the number of healthy life years, and workforce losses, which consequently burdens the social security system and government budget. The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in daily activities which require bilateral functionality of the lower limbs. Therefore, in this study, the investigators examined and compared the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace. This study provides new data on mid-term functionality in children with unilateral and bilateral DDH. It can guide determining the lower extremity functional levels of school-age children with DDH, regular follow-up, early diagnosis, and treatment planning for problems.
Read the detailed description
The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. The implementation of the National DDH Early Diagnosis and Treatment Program by the Türkiye Republic of the Ministry of Health in 2010 significantly reduced the number of patients with DDH diagnosed more than 6 months later. If not appropriately treated, DDH can cause a decrease in the number of healthy life years, and workforce losses, which consequently burdens the social security system and government budget. The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in Daily activities which require bilateral functionality of the lower limbs. Therefore, in this study, the investigators examined and compared the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace. This study provides new data on mid-term functionality in children with unilateral and bilateral DDH. It can guide determining the lower extremity functional levels of school-age children with DDH, regular follow-up, early diagnosis, and treatment planning for problems.
The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in activities such as jumping rope, double-leg jumping, walking, and dynamic balance, which require bilateral functionality of the lower limbs. Therefore, the aim of this study is to examine and compare the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace.
- Conditions
- Developmental Dysplasia of the Hip
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral developmental dysplasia of the hip | Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in one hip. | |
| Bilateral developmental dysplasia of the hip | Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in two hips. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographs
Standard pelvic AP radiographs taken at the first and last admission of the patients were used for radiological evaluation. The acetabular index angle of Hilgenreiner and the centeredge angle of Wiberg were measured. The Tönnis radiographic classification was used for patients with ossified femoral head, and the IHDI classification was used for other patients.
Measured: 2 hours
Lower Extremity Functional Scale
Lower Extremity Functional Scale was used for assess functional status in musculoskeletal dysfunction affecting the lower extremities. The scale mainly consists of 20-items and is a 5-point Likert type (0 = extreme difficulty or or unable to perform activity and 4 = no difficulty). Total score ranged from 0 to 80 points, with higher scores indicating better functional status.
Measured: 30 minutes
10 meters walking test
10 meters walking test was used for assessing the walking speed over a distance of 10 meters
Measured: 10 minutes
Double-leg vertical jump test
The double-leg vertical jump test was used to determine the strength and functional characteristics of the lower extremity extensor muscles. Participants stood upright with feet positioned shoulder width apart, and hands at their hips (to reduce the impact of arm movement). Patients were instructed to jump as high as possible with both legs.
Measured: 15 minutes
Jump rope
Jump rope assesses the strength of the lower extremity muscles. Patients were asked to jump rope for 60 seconds and the number of repetitions was recorded
Measured: 10 minutes
STAR excursion balance test
STAR excursion balance test was used to measure dynamic balance in children. The test was performed with both extremities. In order to reduce the time required to perform the test, reach in 3 directions was measured anterior, posteromedial, and posterolateral, respectively. To normalize the distances reached, the reach distance was divided by the leg length and multiplied by 100.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start11 Nov 2021
- Primary completion11 Feb 2022
- Study completion11 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Developmental Dysplasia of the HipStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raziye Şavkın, Pamukkale University
- Investigators
- Raziye Şavkın, Dr, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853510
- Sponsor's protocol ID
- 60116787-020-125130/20
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savkin R, Buker N, Bayrak G, Yuce Y, Oto M. Are mid-term functional outcomes different in unilateral and bilateral developmental dysplasia of the hip? A cross-sectional study. J Bodyw Mov Ther. 2025 Oct;44:91-96. doi: 10.1016/j.jbmt.2025.05.007. Epub 2025 May 26.
PubMed 40954671Michalak A, Gillibert A, Garyga M, Brismee JM, Gillot T. Immediate effect of neurodynamic mobilization on knee extension angle in slump position and half-seated position and in passive and active settings: a cross-over trial. J Bodyw Mov Ther. 2025 Oct;44:833-840. doi: 10.1016/j.jbmt.2025.07.010. Epub 2025 Jul 12.
PubMed 40954669
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Mid-term Functional Outcomes Different in Unilateral and Bilateral Developmental Dysplasia of the Hip? A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05853510
- Acronym / sponsor ID
- 60116787-020-125130/20
- Conditions
- Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Sep 2022 (actual)
- First posted
- 10 May 2023 (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.
The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. The implementation of the National DDH Early Diagnosis and Treatment Program by the Türkiye Republic of the Ministry of Health in 2010 significantly reduced the number of patients with DDH diagnosed more than 6 months later. If not appropriately treated, DDH can cause a decrease in the number of healthy life years, and workforce losses, which consequently burdens the social security system and government budget. The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in daily activities which require bilateral functionality of the lower limbs. Therefore, in this study, the investigators examined and compared the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace. This study provides new data on mid-term functionality in children with unilateral and bilateral DDH. It can guide determining the lower extremity functional levels of school-age children with DDH, regular follow-up, early diagnosis, and treatment planning for problems.
Detailed description
The annual number of live births in Türkiye is 1,112,859 in 2020 and the estimated incidence of developmental dysplasia of the hip (DDH) is between 5 and 15 per 1000 live births. The implementation of the National DDH Early Diagnosis and Treatment Program by the Türkiye Republic of the Ministry of Health in 2010 significantly reduced the number of patients with DDH diagnosed more than 6 months later. If not appropriately treated, DDH can cause a decrease in the number of healthy life years, and workforce losses, which consequently burdens the social security system and government budget. The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in Daily activities which require bilateral functionality of the lower limbs. Therefore, in this study, the investigators examined and compared the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace. This study provides new data on mid-term functionality in children with unilateral and bilateral DDH. It can guide determining the lower extremity functional levels of school-age children with DDH, regular follow-up, early diagnosis, and treatment planning for problems.
The vast majority of clinical trials comprise risk factors associated with complications after treatment of DDH. Moreover, studies involving functional assessments are generally focused on adult DDH patients with surgical indications. To the best of the investigators' knowledge, mid-term patient-reported and performance-based functionality has not been examined in conservatively treated patients. In addition, it is not known whether the diagnosis of unilateral and bilateral DDH in these patients will make a difference in activities such as jumping rope, double-leg jumping, walking, and dynamic balance, which require bilateral functionality of the lower limbs. Therefore, the aim of this study is to examine and compare the mid-term patient-reported and performance-based functional outcomes in patients with unilateral and bilateral DDH treated with a hip abduction brace.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral developmental dysplasia of the hip | – | –Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in one hip. |
| Bilateral developmental dysplasia of the hip | – | –Diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace in two hips. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who were treated with hip abduction brace in the orthopedics and traumatology department of a university hospital from January 2010 to January 2016 were screened from the hospital registry system. Eligible 72 patients were contacted by telephone and invited to participate in the present study and 54 patients agreed to participate. A total of 35 patients were able to complete all assessments and their data were analyzed. 16 patients had unilateral and 19 patients had bilateral developmental dysplasia of the hip.
Key inclusion criteria (1 listed)
- diagnosed with developmental dysplasia of the hip and treated with a hip abduction brace
Key exclusion criteria (4 listed)
- teratological hip dislocations,
- hip avascular necrosis,
- comorbid disease such as cerebral palsy, myelomeningocele, hypoxic encephalopathy, muscular dystrophy and leukoencephalopathy,
- receiving different treatments before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiographs
Time frame: 2 hours
Standard pelvic AP radiographs taken at the first and last admission of the patients were used for radiological evaluation. The acetabular index angle of Hilgenreiner and the centeredge angle of Wiberg were measured. The Tönnis radiographic classification was used for patients with ossified femoral head, and the IHDI classification was used for other patients.
Lower Extremity Functional Scale
Time frame: 30 minutes
Lower Extremity Functional Scale was used for assess functional status in musculoskeletal dysfunction affecting the lower extremities. The scale mainly consists of 20-items and is a 5-point Likert type (0 = extreme difficulty or or unable to perform activity and 4 = no difficulty). Total score ranged from 0 to 80 points, with higher scores indicating better functional status.
10 meters walking test
Time frame: 10 minutes
10 meters walking test was used for assessing the walking speed over a distance of 10 meters
Double-leg vertical jump test
Time frame: 15 minutes
The double-leg vertical jump test was used to determine the strength and functional characteristics of the lower extremity extensor muscles. Participants stood upright with feet positioned shoulder width apart, and hands at their hips (to reduce the impact of arm movement). Patients were instructed to jump as high as possible with both legs.
Jump rope
Time frame: 10 minutes
Jump rope assesses the strength of the lower extremity muscles. Patients were asked to jump rope for 60 seconds and the number of repetitions was recorded
STAR excursion balance test
Time frame: 10 minutes
STAR excursion balance test was used to measure dynamic balance in children. The test was performed with both extremities. In order to reduce the time required to perform the test, reach in 3 directions was measured anterior, posteromedial, and posterolateral, respectively. To normalize the distances reached, the reach distance was divided by the leg length and multiplied by 100.
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 12 May 2023.
- Derived from this study: PubMed 40954671Savkin R, Buker N, Bayrak G, Yuce Y, Oto M. Are mid-term functional outcomes different in unilateral and bilateral developmental dysplasia of the hip? A cross-sectional study. J Bodyw Mov Ther. 2025 Oct;44:91-96. doi: 10.1016/j.jbmt.2025.05.007. Epub 2025 May 26.
- Derived from this study: PubMed 40954669Michalak A, Gillibert A, Garyga M, Brismee JM, Gillot T. Immediate effect of neurodynamic mobilization on knee extension angle in slump position and half-seated position and in passive and active settings: a cross-over trial. J Bodyw Mov Ther. 2025 Oct;44:833-840. doi: 10.1016/j.jbmt.2025.07.010. Epub 2025 Jul 12.
- Individual participant dataSharing planned: No
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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.
Raziye Şavkın, Dr principal investigator
Pamukkale University
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 the Hip, run by Pamukkale University 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 4 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 12 May 2023. 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?
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?
Radiographs (time frame: 2 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05853510, which also lists 2 linked publications.
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 12 May 2023.