Retrospective Follow-up Study After Periacetabular Osteot... | NCT01348178

Studies
Retrospective Follow-up Study After Periacetabular Osteotomy in Adults

NCT01348178

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 9, 2012Estimated

Enrollment

401Actual

Phase

Not provided

Conditions

Congenital Deformity of Hip Joints

Interventions

Follow-up

Countries

Not provided

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 2012

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

Mar 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

May 3, 2011

First Submission Date that Met QC Criteria

May 4, 2011

First Posted Date

May 5, 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, 2012

Last Update Posted Date

Jan 9, 2012Estimated

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

This is a retrospective study assessing pre- and postoperative radiographic indices of hip dysplasia in order to identify factors predicting failure following Periacetabular Osteotomy (PAO).

Detailed Description

Even though the PAO is applied worldwide and is the preferred joint preserving treatment some issues remains unclear and controversial. One is the exact indication for surgery and risk factors for early failure of the procedure. The is a retrospective cohort study assessing pre- and postoperative radiographic indices of hip dysplasia in order to identify factors predicting failure following PAO. The minimum duration of follow-up is 2 years. Failure following PAO is defined by a WOMAC pain score > 10 or the insertion of a total hip arthroplasty.

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

401Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
developmental dysplasia of the hip, PAO		All patients who underwent periacetabular osteotomy from 1999-2007 at the University Hospital of Aarhus	Procedure: Follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up	Procedure	Follow-up	developmental dysplasia of the hip, PAO

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PAO from 1999-2007

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

Patients who underwent PAO from 1999-2007

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

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013619	Tacrine

Ancestor Terms

ID	Term
D000609	Aminoacridines
D000166	Acridines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided