Acetabular Labral Tear in Dysplastic Hips | NCT01345838

Studies
Acetabular Labral Tear in Dysplastic Hips

NCT01345838

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 9, 2023Actual

Enrollment

104Actual

Phase

Not provided

Conditions

Developmental Dysplasia of the Hip
Labrum

Interventions

labrum

Countries

Denmark

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010Actual

Primary Completion Date

Feb 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

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

Jan 6, 2023

Last Update Posted Date

Jan 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A prospective case-control study of the clinical and radiographic outcome of periacetabular osteotomy in patients with and without preoperative acetabular labral tears.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dysplasia		Patients with developmental dysplasia of the hip undergoing PAO	Procedure: labrum

Interventions

Name	Type	Description	Arm Group Labels	Other Names
labrum	Procedure	Two years follow-up after PAO, to find any differences among patients with and without known acetabular labral tears	Dysplasia

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Developmental dysplasia of the hip

Exclusion Criteria:

contraindication for magnetic resonance arthrography
severe deformities of the femural head

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients with developmental dysplasia of hip and who is scheduled for PAO

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kjeld Soballe, Prof. D.Msc	Orthopedic Research Unit, Aarhus University Hospital	Study Chair
Charlotte Hartig-Andreasen, MD	Orthopedic Research Unit, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopaedic department, Aarhus Universityhospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000082602	Developmental Dysplasia of the Hip

Ancestor Terms

ID	Term
D006617	Hip Dislocation
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided