Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip

June 1, 2010 updated by: Orthopedic Hospital Vienna Speising

Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip. A Comparison of Early Open Reduction Versus Late Open Reduction With Combined Pemberton and Femoral Osteotomies

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vienna, Austria, 1130
        • Orthopedic Hospital Vienna Speising

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 month to 15 years (CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive series of patients hospitalized because of developmental dislocated hip between 1198 and February 2007

Description

Inclusion Criteria:

  • Follow-up > 3 years

Exclusion Criteria:

  • teratological hip dislocation
  • neuromuscular disease
  • previous open reduction at another medical institution

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
Closed reduction < 12 months of age
Open reduction < 12 months of age
Open reduction with concomitant osteotomies > 12 months fo age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Osteonecrosis of the femoral head

Secondary Outcome Measures

Outcome Measure
Secondary reconstructive procedures due to residual acetabular dysplasia

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

January 1, 2009

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

May 28, 2010

First Posted (ESTIMATE)

May 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

May 1, 2010

More Information

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.

Clinical Trials on Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip

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