Pediatric Pelvic Injuries - Epidemiology and Demography

NCT04756947 | Completed

• 1 other identifier: Pediatric Pelvis 01
• Study Type: observational
• Target: 358
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pelvis Injury; Child, Only

Outcome Measures

Primary Outcomes (1)

• Epidemiological study of pediatric pelvic trauma

  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 Outcomes (1)

• Demographical study of pediatric pelvic trauma

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

Study Arms (2)

Pelvic injury

Paediatric patients (age ≤ 18 years) with a single pelvic bone fracture or pelvic ring injury, excluding pathological fractures.

Procedure: surgical treatment according to standard indication criteria; Procedure: conservative treatment 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.

Procedure: surgical treatment according to standard indication criteria; Procedure: conservative treatment according to standard indication criteria

Interventions

surgical treatment according to standard indication criteria PROCEDURE

internal fixation according to standard indication criteria

Pelvic and acetabular injury; Pelvic injury

conservative treatment according to standard indication criteria PROCEDURE

conservative therapy according to standard indication criteria

Pelvic and acetabular injury; Pelvic injury

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age ≤ 18 years
• Single pelvic bone fractures or pelvic ring injuries
• Age ≤ 18 years
• Combined pelvic and acetabular injuries
• Isolated fractures of the acetabulum

You may not qualify if:

• Pathological fractures

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Faculty Hospital Kralovske Vinohrady: collaborator
• University Hospital Pilsen: collaborator

Related Publications (2)

• 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.

  PMID: 28302282 BACKGROUND

• 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.

  PMID: 26312114 BACKGROUND

Study Officials

• Valer Dzupa, MD

  Charles University, Czech Republic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 16, 2021
• Study Start: January 1, 2007
• Primary Completion: December 31, 2019
• Study Completion: February 1, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share