- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431871
Sequelae of Developmental Dysplasia of the Hip
Structural and Functional Sequelae of Developmental Dysplasia of the Hip
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Oulu, Finland, 90100
- University of Oulu; Oulu University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for person treated for DDH:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Treated for DDH in childhood
Subjects have had DDH in childhood.
DDH has been diagnosed before age of 1,5 years and treated for.
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Control
Age an sex matched controls of DDH patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wibergs Centre-Edge Angle
Time Frame: 10 - 30 years after DDH has been treated
|
angle degree
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10 - 30 years after DDH has been treated
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Time Frame: 10 - 30 years after DDH has been treated
|
score in numbers
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10 - 30 years after DDH has been treated
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Oral Heath Impact Profile
Time Frame: 10 - 30 years after DDH has been treated
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Oral Heath Impact Profile (OHIP-14) -questionaire to assess Oral Health-related Quality of Life
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10 - 30 years after DDH has been treated
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Occlusal asymmetries
Time Frame: 10 - 30 years after DDH has been treated
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Determined by dental examination and intraoral scan
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10 - 30 years after DDH has been treated
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Presence of facial asymmetry
Time Frame: 10 - 30 years after DDH has been treated
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Determined by 3D -photogrammetric images
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10 - 30 years after DDH has been treated
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hip deformity
Time Frame: 10 - 30 years after DDH has been treated
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Determined by hip radiograph
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10 - 30 years after DDH has been treated
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Asymmetry in clinical hip examination
Time Frame: 10 - 30 years after DDH has been treated
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Determined by clinical hip examination
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10 - 30 years after DDH has been treated
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juhana Leppilahti, Professor, University of Oulu
- Study Director: Marita Valkama, Ph.D., M.D, University of Oulu, Oulu University Hospital, MRC Oulu
- Study Director: Virpi Harila, Ph.D., University of Oulu, MRC Oulu
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EETTMK:94/2014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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