NCT02431871

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jan 2016Dec 2026

First Submitted

Initial submission to the registry

April 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

6.9 years

First QC Date

April 20, 2015

Last Update Submit

November 27, 2023

Conditions

Developmental Dysplasia of the HipHip Dysplasia

Keywords

Developmental dysplasia of the hipHip dysplasiaOcclusal defect

Outcome Measures

Primary Outcomes (1)

  • Wibergs Centre-Edge Angle

    angle degree

    10 - 30 years after DDH has been treated

Secondary Outcomes (4)

  • The Copenhagen Hip and Groin Outcome Score (HAGOS)

    10 - 30 years after DDH has been treated

  • Oral Heath Impact Profile

    10 - 30 years after DDH has been treated

  • Occlusal asymmetries

    10 - 30 years after DDH has been treated

  • Presence of facial asymmetry

    10 - 30 years after DDH has been treated

Other Outcomes (2)

  • Hip deformity

    10 - 30 years after DDH has been treated

  • Asymmetry in clinical hip examination

    10 - 30 years after DDH has been treated

Study Arms (2)

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

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu; Oulu University Hospital

Oulu, 90100, Finland

Location

MeSH Terms

Conditions

Developmental Dysplasia of the HipHip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and InjuriesHip Injuries

Study Officials

  • Juhana Leppilahti, Professor

    University of Oulu

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

May 1, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2026

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

FI(1)