NCT01133938

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
Last Updated

June 3, 2010

Status Verified

May 1, 2010

Enrollment Period

1.1 years

First QC Date

May 28, 2010

Last Update Submit

June 1, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Osteonecrosis of the femoral head

Secondary Outcomes (1)

  • Secondary reconstructive procedures due to residual acetabular dysplasia

Study Arms (3)

Closed reduction < 12 months of age

Open reduction < 12 months of age

Open reduction with concomitant osteotomies > 12 months fo age

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Follow-up \> 3 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopedic Hospital Vienna Speising

Vienna, Vienna, 1130, Austria

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2010

First Posted

May 31, 2010

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

May 1, 2010

Last Updated

June 3, 2010

Record last verified: 2010-05

Locations