Developmental Dislocation of the HipNCT02163603
A Trial on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip
An observational study of Developmental Dislocation of the Hip and Congenital Dislocation of Hip, run by Hongwen Xu.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Developmental Dislocation of the Hip, Congenital Dislocation of Hip, Residual Deformity
- What is being tested?
- Pelvic osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The south of China
Who may be able to join
- The inclusion criteria consists of patients with large acetabular index ,small central-edge angle after reduction in developmental dislocation of the hip
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Developmental Dislocation of the Hip, Congenital Dislocation of Hip, Residual Deformity, Reduction
- Being tested
- Pelvic osteotomy
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic osteotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pelvic osteotomy | Not described Receives: Procedure: Pelvic osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Dislocation of the HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hongwen Xu
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hunan Children's Hospital, Shenzhen Children's Hospital, Foshan Hospital of Traditional Chinese Medicine, Wuhan Women and Children's Medical Center
- Responsible party
- Sponsor-investigator, Hongwen Xu, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163603
- Sponsor's protocol ID
- GuangzhouWCMC
- Status last verified
- Mar 2016
- First submitted
- 6 May 2014
- Last updated
- 21 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip
- ClinicalTrials.gov ID
- NCT02163603
- Acronym / sponsor ID
- GuangzhouWCMC
- Conditions
- Developmental Dislocation of the Hip, Congenital Dislocation of Hip, Residual Deformity, Reduction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Hongwen XuUniversity, hospital or other
- Collaborators
- Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hunan Children's Hospital, Shenzhen Children's Hospital, Foshan Hospital of Traditional Chinese Medicine, Wuhan Women and Children's Medical Center
- Study start
- Sep 2014
- Primary completion
- Dec 2024 (estimated)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic osteotomy | – | Procedure: Pelvic osteotomy |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The south of China
Key inclusion criteria (1 listed)
- The inclusion criteria consists of patients with large acetabular index ,small central-edge angle after reduction in developmental dislocation of the hip
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic osteotomy | Procedure or surgery | Pelvic osteotomy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Dislocation of the Hip and Congenital Dislocation of Hip, run by Hongwen Xu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early treatment can achieve good results in the residual deformity after reduction in developmental dislocation of the hip (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.