Pediatric Pelvic Injuries - Epidemiology and Demography

February 14, 2021 updated by: Valer Dzupa, Charles University, Czech Republic

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

Detailed Description

Study design: Retrospective analysis (13 years), excluding pathological fractures. AO/OTA type, epidemiological data, mode of treatment, and complications were recorded. Data were analyzed using the Fisher exact test and the Wilcoxon test.

Study Type

Observational

Enrollment (Actual)

358

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 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

358 patients (243 boys, 115 girls), mean age (SD) 14.1 ± 3.0 years

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

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
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.
  1. The overall incidence of pelvic ring injury per 100,000 children per year.
  2. The overall incidence of isolated acetabular fractures per 100,000 children per year.
  3. The overall incidence of combined pelvic ring and acetabular injuries per 100,000 children per year.
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.
  1. Comparison of the incidence of observed injuries by sex.
  2. Comparison of the incidence of observed injuries according to the severity of trauma (single trauma vs. multiple trauma).
  3. The incidence of the types of pelvic ring injury (according to AO/OTA classification) per 100,000 children per year.
Follow-up of each patient for longer then 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Valer Dzupa, MD, Charles University, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)

January 1, 2007

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 14, 2021

Last Verified

February 1, 2021

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)?

NO

IPD Plan Description

Patients´ personal data will not be shared. The study results will be shared when published in a medical journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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