Sequelae of Developmental Dysplasia of the Hip

November 27, 2023 updated by: University of Oulu

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Estimated)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oulu, Finland, 90100
        • University of Oulu; Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

10-30 years old patientstreated for DDH in early childhood in Oulu University Hospital

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 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
10 - 30 years after DDH has been treated

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
10 - 30 years after DDH has been treated
Oral Heath Impact Profile
Time Frame: 10 - 30 years after DDH has been treated
Oral Heath Impact Profile (OHIP-14) -questionaire to assess Oral Health-related Quality of Life
10 - 30 years after DDH has been treated
Occlusal asymmetries
Time Frame: 10 - 30 years after DDH has been treated
Determined by dental examination and intraoral scan
10 - 30 years after DDH has been treated
Presence of facial asymmetry
Time Frame: 10 - 30 years after DDH has been treated
Determined by 3D -photogrammetric images
10 - 30 years after DDH has been treated

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip deformity
Time Frame: 10 - 30 years after DDH has been treated
Determined by hip radiograph
10 - 30 years after DDH has been treated
Asymmetry in clinical hip examination
Time Frame: 10 - 30 years after DDH has been treated
Determined by clinical hip examination
10 - 30 years after DDH has been treated

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 1, 2022

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimated)

May 1, 2015

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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