Pediatric Pelvic Injuries - Epidemiology and Demography

Child, Only Clinical Trial

Official title:

Epidemiological Study of Pediatric Pelvic Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756947
• Other study ID #: Pediatric Pelvis 01
• Status: Completed
• Start date: January 1, 2007
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Pelvis Injury
• Wounds and Injuries

Intervention

Procedure:
• surgical treatment according to standard indication criteria
internal fixation according to standard indication criteria
• conservative treatment according to standard indication criteria
conservative therapy according to standard indication criteria

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Faculty Hospital Kralovske Vinohrady, University Hospital Pilsen

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiological study of pediatric pelvic trauma	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.	Follow-up of each patient for minimum 12 months.
Secondary	Demographical study of pediatric pelvic trauma	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.	Follow-up of each patient for longer then 12 months.