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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01133938
Other study ID # OR-27052010
Secondary ID
Status Completed
Phase N/A
First received May 28, 2010
Last updated June 1, 2010
Start date January 2009
Est. completion date May 2010

Study information

Verified date May 2010
Source Orthopedic Hospital Vienna Speising
Contact n/a
Is FDA regulated No
Health authority Austria: Institutional Review Board
Study type Observational

Clinical Trial Summary

Several risk factors for the development of osteonecrosis of the femoral head following treatment of developmental dislocated hip have been reported. The need for further research with a large-enough sample size including statistical adjustment of confounders was demanded. The purpose of the present study was to find reliable predictors of osteonecrosis in patients managed for developmental dislocation of the hip and to evaluate if delayed treatment increased the risk of residual acetabular dysplasia requiring secondary surgeries.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date May 2010
Est. primary completion date February 2010
Accepts healthy volunteers
Gender Both
Age group 1 Month to 15 Years
Eligibility Inclusion Criteria:

- Follow-up > 3 years

Exclusion Criteria:

- teratological hip dislocation

- neuromuscular disease

- previous open reduction at another medical institution

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Orthopedic Hospital Vienna Speising Vienna

Sponsors (1)

Lead Sponsor Collaborator
Orthopedic Hospital Vienna Speising

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Osteonecrosis of the femoral head
Secondary Secondary reconstructive procedures due to residual acetabular dysplasia