Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated HipNCT01133938
Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip
An observational study of Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip
- How many people
- 79 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2009to May 2010
- 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 month to 15 years
- All sexes
- Child
Study population: Consecutive series of patients hospitalized because of developmental dislocated hip between 1198 and February 2007
Who may be able to join
- Follow-up > 3 years
Who cannot join
- teratological hip dislocation
- neuromuscular disease
- previous open reduction at another medical institution
Trial locations and contacts
1 site in 1 country.
Austria1 site
Orthopedic Hospital Vienna Speising
Vienna, State of Vienna, 1130
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Closed reduction < 12 months of age | Not described | |
| Open reduction < 12 months of age | Not described | |
| Open reduction with concomitant osteotomies > 12 months fo age | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteonecrosis of the femoral head
Secondary outcomes (1)
Secondary reconstructive procedures due to residual acetabular dysplasia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Hospital Vienna Speising
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133938
- Sponsor's protocol ID
- OR-27052010
- Status last verified
- May 2010
- First submitted
- 28 May 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01133938
- Acronym / sponsor ID
- OR-27052010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Orthopedic Hospital Vienna SpeisingUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 May 2010 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Closed reduction < 12 months of age | – | – |
| Open reduction < 12 months of age | – | – |
| Open reduction with concomitant osteotomies > 12 months fo age | – | – |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- Consecutive series of patients hospitalized because of developmental dislocated hip between 1198 and February 2007
Key inclusion criteria (1 listed)
- Follow-up > 3 years
Key exclusion criteria (3 listed)
- teratological hip dislocation
- neuromuscular disease
- previous open reduction at another medical institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Osteonecrosis of the femoral head
1 secondary outcome
Secondary reconstructive procedures due to residual acetabular dysplasia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip, run by Orthopedic Hospital Vienna Speising at 1 site in Austria.
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 3 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: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Osteonecrosis of the femoral head. 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 3 Jun 2010.