Modified Triple Osteotomy for Acetabular Dysplasia | NCT01285154

Studies
Modified Triple Osteotomy for Acetabular Dysplasia

NCT01285154

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Apr 22, 2011Estimated

Enrollment

2Estimated

Phase

Not provided

Conditions

Sharp Angle
Center Edge Angle
Femoral Head Extrusion Index
Center Head Distance Discrepancy

Interventions

Not provided

Countries

Taiwan

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 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

May 2011Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Jan 26, 2011

First Submission Date that Met QC Criteria

Jan 26, 2011

First Posted Date

Jan 27, 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

Apr 21, 2011

Last Update Posted Date

Apr 22, 2011Estimated

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

Steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. The investigators modified the technique with two anterior incisions and ramus cuts close to inferior acetabulum. The purpose of this study is to compare these two techniques in femoral head coverage

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

2Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Traditional Steel Triple Osteotomy		Traditional technique
Modified Triple Osteotomy		Modified technique

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Symptomatic acetabular dysplasia in adolescent or young adult
Closed triradiate cartilage
Minor coxarthrosis with Tonnis grades at 1 or 2

Exclusion Criteria:

High subluxation or complete dislocation of the hip joint
Severe osteoarthrosis
Combined with proximal femoral osteotomy that changed the femoral neck shaft angle (such as varus or valgus osteotomy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Young adults and adolescents underwent triple innominate osteotomy for symptomatic acetabular dysplasia in our institution

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi-Chen Li, M.D.	Contact	886-2-23123456	62515	atcg0125@gmail.com

Overall Officials

Name	Affiliation	Role
Yi-Chen Li, M.D.	National Taiwan University Hospital, Department of Orthopaedic Surgery	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006617	Hip Dislocation

Ancestor Terms

ID	Term
D004204	Joint Dislocations
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided