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NCT Number: NCT04756947

Pediatric Pelvic Injuries - Epidemiology and Demography

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.

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Key information

Conditions

Pelvis Injury Child, Only

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical treatment according to standard indication criteria

Procedure

internal fixation according to standard indication criteria

conservative treatment according to standard indication criteria

Procedure

conservative therapy according to standard indication criteria

Primary outcomes

  1. Epidemiological study of pediatric pelvic trauma

    Time frame: Follow-up of each patient for minimum 12 months.

    • The overall incidence of pelvic ring injury per 100,000 children per year.
    • The overall incidence of isolated acetabular fractures per 100,000 children per year.
    • The overall incidence of combined pelvic ring and acetabular injuries per 100,000 children per year.

Secondary outcomes

  1. Demographical study of pediatric pelvic trauma

    Time frame: Follow-up of each patient for longer then 12 months.

    • Comparison of the incidence of observed injuries by sex.
    • Comparison of the incidence of observed injuries according to the severity of trauma (single trauma vs. multiple trauma).
    • The incidence of the types of pelvic ring injury (according to AO/OTA classification) per 100,000 children per year.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Faculty Hospital Kralovske Vinohrady
  • University Hospital Pilsen

Registry information

Official study title

Epidemiological Study of Pediatric Pelvic Injuries

Important dates

Study start
2007
Primary completion
2019
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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