Pelvis InjuryNCT04756947
Pediatric Pelvic Injuries - Epidemiology and Demography
An observational study of Pelvis Injury and Child, Only, run by Charles University, Czech Republic.
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pelvis Injury, Child, Only
- What is being tested?
- surgical treatment according to standard indication criteria and conservative treatment according to standard indication criteria
- Type of treatment
- Surgery or procedure
- How many people
- 358 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 358 patients (243 boys, 115 girls), mean age (SD) 14.1 ± 3.0 years
Who may be able to join
- Age ≤ 18 years
- Single pelvic bone fractures or pelvic ring injuries
- Age ≤ 18 years
- Combined pelvic and acetabular injuries
- Isolated fractures of the acetabulum
Who cannot join
- Pathological fractures
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvis Injury, Child, Only
- Being tested
- surgical treatment according to standard indication criteria, conservative treatment according to standard indication criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatment according to standard indication criteriaProcedure or surgery
internal fixation according to standard indication criteria
conservative treatment according to standard indication criteriaProcedure or surgery
conservative therapy according to standard indication criteria
| Study group | Role | What they receive |
|---|---|---|
| Pelvic injury | Paediatric patients (age ≤ 18 years) with a single pelvic bone fracture or pelvic ring injury, excluding pathological fractures. Receives: 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. Receives: Procedure: surgical treatment according to standard indication criteria; Procedure: conservative treatment according to standard indication criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up of each patient for minimum 12 months.
Secondary outcomes (1)
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.
Measured: Follow-up of each patient for longer then 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jan 2007
- Primary completion31 Dec 2019
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pelvis InjuryStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady, University Hospital Pilsen
- Responsible party
- Principal investigator, Valer Dzupa, Charles University, Czech Republic
- Investigators
- Valer Dzupa, MD, Study chair, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756947
- Sponsor's protocol ID
- Pediatric Pelvis 01
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients´ personal data will not be shared. The study results will be shared when published in a medical journal.
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.
PubMed 28302282Tosounidis 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.
PubMed 26312114
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Pediatric Pelvic Injuries
- ClinicalTrials.gov ID
- NCT04756947
- Acronym / sponsor ID
- Pediatric Pelvis 01
- Conditions
- Pelvis Injury, Child, Only
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady, University Hospital Pilsen
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic injury | – | Procedure: surgical treatment according to standard indication criteria, Procedure: conservative treatment according to standard indication criteriaPaediatric patients (age ≤ 18 years) with a single pelvic bone fracture or pelvic ring injury, excluding pathological fractures. |
| Pelvic and acetabular injury | – | Procedure: surgical treatment according to standard indication criteria, Procedure: conservative treatment according to standard indication criteriaPaediatric patients (age ≤ 18 years) with a combined pelvic and acetabular injury or an isolated acetabular fracture, excluding pathological fractures. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 358 patients (243 boys, 115 girls), mean age (SD) 14.1 ± 3.0 years
Key inclusion criteria (5 listed)
- Age ≤ 18 years
- Single pelvic bone fractures or pelvic ring injuries
- Age ≤ 18 years
- Combined pelvic and acetabular injuries
- Isolated fractures of the acetabulum
Key exclusion criteria (1 listed)
- Pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical treatment according to standard indication criteriainternal fixation according to standard indication criteria | Procedure or surgery | Pelvic and acetabular injury, Pelvic injury |
| conservative treatment according to standard indication criteriaconservative therapy according to standard indication criteria | Procedure or surgery | Pelvic and acetabular injury, Pelvic injury |
Primary outcome
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.
1 secondary outcome
Demographical study of pediatric pelvic trauma
Time frame: Follow-up of each patient for longer then 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 28302282DeFrancesco 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.
- Background: PubMed 26312114Tosounidis 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.
- Individual participant dataSharing planned: No. Patients´ personal data will not be shared. The study results will be shared when published in a medical journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valer Dzupa, MD study chair
Charles University, Czech Republic
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvis Injury and Child, Only, run by Charles University, Czech Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological study of pediatric pelvic trauma (time frame: Follow-up of each patient for minimum 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756947, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.