- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02163603
A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip
March 18, 2016 updated by: Hongwen Xu
A Multi-center Study on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The south of China
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pelvic osteotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early treatment can achieve good results in the residual deformity after reduction in developmental dislocation of the hip
Time Frame: 3 years
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
May 6, 2014
First Submitted That Met QC Criteria
June 11, 2014
First Posted (ESTIMATE)
June 13, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
March 21, 2016
Last Update Submitted That Met QC Criteria
March 18, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouWCMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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