A Trial on the Opportunity and Treatment of Residual Defo... | NCT02163603

Studies
A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip

NCT02163603

Sponsor

Hongwen Xu

Status

Unknown status

Last Update Posted

Mar 21, 2016Estimated

Enrollment

2Estimated

Phase

Not provided

Conditions

Developmental Dislocation of the Hip
Congenital Dislocation of Hip
Residual Deformity
Reduction

Interventions

Pelvic osteotomy

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2024Estimated

Completion Date

Not provided

First Submitted Date

May 6, 2014

First Submission Date that Met QC Criteria

Jun 11, 2014

First Posted Date

Jun 13, 2014Estimated

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

Mar 18, 2016

Last Update Posted Date

Mar 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hongwen Xu, Guangzhou Women and Children's Medical Center, Guangzhou Women and Children's Medical CenterSponsor-Investigator

Lead Sponsor

Hongwen XuOTHER

Collaborators

Name	Class
Tongji Hospital	OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	OTHER
Hunan Children's Hospital	OTHER_GOV

Description Module

Brief Summary

Developmental dislocation of the hip is a common disease in children, and its incidence in China is about 9 ‰.The pathological changes of it is complex. The reluxation , subluxation and residual deformity and other complications are relatively common after treatment. The X-ray appears great acetabular index and wide medial gap , small central-edge angle. As there is no effective methods for treating such complications , investigators conducted this trial to find and prove optimal intervention time and treatment programs.

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

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

Label	Type	Description	Intervention Names
Pelvic osteotomy			Procedure: Pelvic osteotomy

Name	Type	Description	Arm Group Labels	Other Names
Pelvic osteotomy	Procedure		Pelvic osteotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early treatment can achieve good results in the residual deformity after reduction in developmental dislocation of the hip	Acetabular index of all ages were measured ，and the acetabular index of patients getting early treatment (pelvis osteotomy ) is normal in all ages according to "The measurements of normal acetabular index and Sharp acetabular angle in Chinese hips" publised on Chinese Journal of Orthopaedics in 2010.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The inclusion criteria consists of patients with large acetabular index ,small central-edge angle after reduction in developmental dislocation of the hip

Exclusion Criteria:

Age >14 years
Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth.
Patients are complicated with cerebral palsy, multiple joint contractures disease.
Children are complicated with dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
Parents refused further treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

14 Years

Standard Ages

Child

Study Population

The south of China

Sampling Method

Probability Sample

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