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

Reduction Clinical Trial

Official title:

A Multi-center Study on the Opportunity and Treatment of Residual Deformity After Reduction in Developmental Dislocation of the Hip

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02163603
• Other study ID #: GuangzhouWCMC
• Status: Not yet recruiting
• Phase: N/A
• First received: May 6, 2014
• Last updated: June 11, 2014
• Start date: June 2014

Study information

• Verified date: May 2014
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Dislocation of Hip
• Developmental Dislocation of the Hip
• Dislocations
• Hip Dislocation
• Hip Dislocation, Congenital
• Reduction
• Residual Deformity

Intervention

Procedure:
• Pelvic osteotomy

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center	Foshan Hospital of Traditional Chinese Medicine, Hunan Children's Hospital, Shenzhen Children's Hospital, Tongji Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes