Developmental Dysplasia of the HipNCT02431871
Sequelae of Developmental Dysplasia of the Hip
An observational study of Developmental Dysplasia of the Hip and Hip Dysplasia, run by University of Oulu at 1 site in Finland.
Trial summary
The aim of this study is to assess long term effects of developmental dysplasia of the hip (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH… Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Developmental Dysplasia of the Hip, Hip Dysplasia
- How many people
- 340 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2016to Dec 2026
- 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 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 10-30 years old patientstreated for DDH in early childhood in Oulu University Hospital
Who may be able to join
- DDH has been diagnosed by clinical examination, ultrasound examination or by radiological examination and treatment begun before age of 1,5 years.
- Treated in Oulu University Hospital
Who cannot join
- neurological or developmental condition which can influence hip development such as cerebral palsy or spina bifida
- other significant congenital anomalies of musculoskeletal system such as club feet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structural and Functional Sequelae of Developmental Dysplasia of the Hip
The aim of this study is to assess long term effects of developmental dysplasia of the hip (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their childhood with age and sex matched controls.
Read the detailed description
Developmental dysplasia of the hip (DDH) is the most common musculoskeletal disorder in infancy. However there are few reports of long term effects of successfully treated DDH. Incidence of DDH in neonatal period is approximately 1-10/1000 depending on screening protocols used, the age of the infant during screening and which ultrasonographic findings are considered normal and which DDH. The prevalence of hip dysplasia in adult population is grossly 4 % when using Wibergs Centre-Edge (CE) ≤ 20° as definition of dysplasia. It is still unclear, what is the relation between adult acetabular dysplasia and developmental dysplasia in children. Hip dysplasia overall is a major contributing factor in hip osteoarthrosis and total hip replacement in young adults.
The aim of this study is to assess long term effects of developmental dysplasia of the hip to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their early childhood with age and sex matched controls.
- Conditions
- Developmental Dysplasia of the Hip, Hip Dysplasia
- Keywords
- Developmental dysplasia of the hip, Hip dysplasia, Occlusal defect
- Medical subject headings
- Developmental Dysplasia of the Hip, Hip Dislocation
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 |
|---|---|---|
| Treated for DDH in childhood | Subjects have had DDH in childhood. DDH has been diagnosed before age of 1,5 years and treated for. | |
| Control | Age an sex matched controls of DDH patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wibergs Centre-Edge Angle
angle degree
Measured: 10 - 30 years after DDH has been treated
Secondary outcomes (4)
The Copenhagen Hip and Groin Outcome Score (HAGOS)
score in numbers
Measured: 10 - 30 years after DDH has been treated
Oral Heath Impact Profile
Oral Heath Impact Profile (OHIP-14) -questionaire to assess Oral Health-related Quality of Life
Measured: 10 - 30 years after DDH has been treated
Occlusal asymmetries
Determined by dental examination and intraoral scan
Measured: 10 - 30 years after DDH has been treated
Presence of facial asymmetry
Determined by 3D -photogrammetric images
Measured: 10 - 30 years after DDH has been treated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2022
- Study completionDec 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 the HipStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juhana Leppilahti, Professor, Principal investigator, University of OuluMarita Valkama, Ph.D., M.D, Study director, University of Oulu, Oulu University Hospital, MRC OuluVirpi Harila, Ph.D., Study director, University of Oulu, MRC Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431871
- Sponsor's protocol ID
- EETTMK:94/2014
- Status last verified
- Nov 2023
- First submitted
- 20 Apr 2015
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Sequelae of Developmental Dysplasia of the Hip
- ClinicalTrials.gov ID
- NCT02431871
- Acronym / sponsor ID
- EETTMK:94/2014
- Conditions
- Developmental Dysplasia of the Hip, Hip Dysplasia
- Keywords
- Developmental dysplasia of the hip, Hip dysplasia, Occlusal defect
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 May 2015 (estimated)
- 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 aim of this study is to assess long term effects of developmental dysplasia of the hip (DDH) to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their childhood with age and sex matched controls.
Detailed description
Developmental dysplasia of the hip (DDH) is the most common musculoskeletal disorder in infancy. However there are few reports of long term effects of successfully treated DDH. Incidence of DDH in neonatal period is approximately 1-10/1000 depending on screening protocols used, the age of the infant during screening and which ultrasonographic findings are considered normal and which DDH. The prevalence of hip dysplasia in adult population is grossly 4 % when using Wibergs Centre-Edge (CE) ≤ 20° as definition of dysplasia. It is still unclear, what is the relation between adult acetabular dysplasia and developmental dysplasia in children. Hip dysplasia overall is a major contributing factor in hip osteoarthrosis and total hip replacement in young adults.
The aim of this study is to assess long term effects of developmental dysplasia of the hip to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their early childhood with age and sex matched controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated for DDH in childhood | – | –Subjects have had DDH in childhood. DDH has been diagnosed before age of 1,5 years and treated for. |
| Control | – | –Age an sex matched controls of DDH patients |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 10-30 years old patientstreated for DDH in early childhood in Oulu University Hospital
Key inclusion criteria (2 listed)
- DDH has been diagnosed by clinical examination, ultrasound examination or by radiological examination and treatment begun before age of 1,5 years.
- Treated in Oulu University Hospital
Key exclusion criteria (2 listed)
- neurological or developmental condition which can influence hip development such as cerebral palsy or spina bifida
- other significant congenital anomalies of musculoskeletal system such as club feet
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
Wibergs Centre-Edge Angle
Time frame: 10 - 30 years after DDH has been treated
angle degree
4 secondary outcomes
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time frame: 10 - 30 years after DDH has been treated
Oral Heath Impact Profile
Time frame: 10 - 30 years after DDH has been treated
Occlusal asymmetries
Time frame: 10 - 30 years after DDH has been treated
Presence of facial asymmetry
Time frame: 10 - 30 years after DDH has been treated
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 29 Nov 2023.
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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.
Juhana Leppilahti, Professor principal investigator
University of Oulu
Marita Valkama, Ph.D., M.D study director
University of Oulu, Oulu University Hospital, MRC Oulu
Virpi Harila, Ph.D. study director
University of Oulu, MRC Oulu
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 and Hip Dysplasia, run by University of Oulu at 1 site in Finland.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 29 Nov 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 Finland. 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?
Wibergs Centre-Edge Angle (time frame: 10 - 30 years after DDH has been treated). 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 29 Nov 2023.