- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756947
Pediatric Pelvic Injuries - Epidemiology and Demography
Epidemiological Study of Pediatric Pelvic Injuries
A retrospective epidemiological study of pediatric pelvic injury from level 1 trauma centre.
Hypothesis: In the pediatric population, majority of pelvic injuries is of type A according to AO/OTA (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association) classification, the treatment is mostly conservative and complications of injury and treatment are less common than in adults.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria of primary study group:
- Age ≤ 18 years
- Single pelvic bone fractures or pelvic ring injuries
Inclusion Criteria of secondary study group:
- Age ≤ 18 years
- Combined pelvic and acetabular injuries
- Isolated fractures of the acetabulum
Exclusion Criteria:
- Pathological fractures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pelvic injury
Paediatric patients (age ≤ 18 years) with a single pelvic bone fracture or pelvic ring injury, excluding pathological fractures.
|
internal fixation according to standard indication criteria
conservative therapy according to standard indication criteria
|
Pelvic and acetabular injury
Paediatric patients (age ≤ 18 years) with a combined pelvic and acetabular injury or an isolated acetabular fracture, excluding pathological fractures.
|
internal fixation according to standard indication criteria
conservative therapy according to standard indication criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epidemiological study of pediatric pelvic trauma
Time Frame: Follow-up of each patient for minimum 12 months.
|
|
Follow-up of each patient for minimum 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographical study of pediatric pelvic trauma
Time Frame: Follow-up of each patient for longer then 12 months.
|
|
Follow-up of each patient for longer then 12 months.
|
Collaborators and Investigators
Investigators
- Study Chair: Valer Dzupa, MD, Charles University, Czech Republic
Publications and helpful links
General Publications
- DeFrancesco CJ, Sankar WN. Traumatic pelvic fractures in children and adolescents. Semin Pediatr Surg. 2017 Feb;26(1):27-35. doi: 10.1053/j.sempedsurg.2017.01.006. Epub 2017 Jan 5.
- Tosounidis TH, Sheikh H, Giannoudis PV. Pelvic Fractures in Paediatric Polytrauma Patients: Classification, Concomitant Injuries and Early Mortality. Open Orthop J. 2015 Jul 31;9:303-12. doi: 10.2174/1874325001509010303. eCollection 2015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pediatric Pelvis 01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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