Sequelae of Developmental Dysplasia of the Hip | NCT02431871

Studies
Sequelae of Developmental Dysplasia of the Hip

NCT02431871

Sponsor

University of Oulu

Status

Active, not recruiting

Last Update Posted

Nov 29, 2023Actual

Enrollment

340Estimated

Phase

Not provided

Conditions

Developmental Dysplasia of the Hip
Hip Dysplasia

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016Actual

Primary Completion Date

Dec 2022Actual

Completion Date

Dec 2026Estimated

First Submitted Date

Apr 20, 2015

First Submission Date that Met QC Criteria

Apr 27, 2015

First Posted Date

May 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

340Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wibergs Centre-Edge Angle	angle degree	10 - 30 years after DDH has been treated

Secondary Outcomes

Measure	Description	Time Frame
The Copenhagen Hip and Groin Outcome Score (HAGOS)	score in numbers	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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Oulu; Oulu University Hospital		Oulu		90100	Finland

Condition Browse Module

MeSH Terms

ID	Term
D000082602	Developmental Dysplasia of the Hip
D006617	Hip Dislocation

Ancestor Terms

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D009139	Musculoskeletal Abnormalities

Browse Leaves

Not provided

Browse Branches

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