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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02431871
Other study ID # EETTMK:94/2014
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2026

Study information

Verified date November 2023
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 in their childhood with age and sex matched controls.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 340
Est. completion date December 2026
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Finland University of Oulu; Oulu University Hospital Oulu

Sponsors (1)

Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Hip deformity Determined by hip radiograph 10 - 30 years after DDH has been treated
Other Asymmetry in clinical hip examination Determined by clinical hip examination 10 - 30 years after DDH has been treated
Primary Wibergs Centre-Edge Angle angle degree 10 - 30 years after DDH has been treated
Secondary The Copenhagen Hip and Groin Outcome Score (HAGOS) score in numbers 10 - 30 years after DDH has been treated
Secondary Oral Heath Impact Profile Oral Heath Impact Profile (OHIP-14) -questionaire to assess Oral Health-related Quality of Life 10 - 30 years after DDH has been treated
Secondary Occlusal asymmetries Determined by dental examination and intraoral scan 10 - 30 years after DDH has been treated
Secondary Presence of facial asymmetry Determined by 3D -photogrammetric images 10 - 30 years after DDH has been treated
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