- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133938
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
Status
Completed
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
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Vienna, Austria, 1130
- Orthopedic Hospital Vienna Speising
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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 |
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Closed reduction < 12 months of age
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Open reduction < 12 months of age
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Open reduction with concomitant osteotomies > 12 months fo age
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Osteonecrosis of the femoral head
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Secondary Outcome Measures
Outcome Measure |
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Secondary reconstructive procedures due to residual acetabular dysplasia
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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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OR-27052010
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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University of LiegeCompletedNon Traumatic Osteonecrosis of the Femoral Head (Hip)Belgium
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Ataturk UniversityEnrolling by invitationHip Osteoarthritis | Osteonecrosis of the Femoral Head | Avascular Necrosis of Femur Head | Dysplasia of Hip Joint | Hip SurgeriesTurkey (Türkiye)
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The First Affiliated Hospital of Xinxiang Medical...RecruitingOsteonecrosis of the Femoral HeadChina
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Ankara City Hospital BilkentCompletedOsteonecrosis of the Femoral HeadTurkey (Türkiye)
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Johns Hopkins UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)RecruitingOsteonecrosis of the Femoral Head | Avascular Necrosis of the Femoral HeadUnited States
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Jianming TanUnknownOsteochondritis of the Femoral HeadChina
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Erasme University HospitalUniversity of Liege; Bone Therapeutics S.ACompletedAvascular Necrosis of Femur HeadBelgium
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Zimmer BiometRecruitingHip Osteoarthritis | Avascular Necrosis of the Femoral Head | Acute Traumatic Fracture of the Femoral Head or NeckUnited States
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Banc de Sang i TeixitsEuropean Regional Development Fund; Ministerio de Sanidad, Servicios Sociales... and other collaboratorsCompleted