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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04217499
Other study ID # BASSINJO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 31, 2020
Est. completion date April 26, 2022

Study information

Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pelvic ring fractures are common and often the result of high energy trauma but also sometimes of lower energy trauma in older patients. A good classification and description of the fracture is essential to the choice of treatment. The classifications used to describe these fractures are numerous (Tile modified AO, Young and Burgess, Letournel, Rommens) and of a descriptive order more or less depending on the lesion mechanism allowing some to orient the surgical reduction technique. However, none of them helps with the choice of surgical or functional treatment, which is currently based on obvious notions of instability and / or displacement of lesions and, by habit, all different services. In addition, the complexity of these classifications leads to poor reproducibility of these. A new method for analyzing unitary lesions has been developed in the Orthopedic Surgery department of the Paris Saint-Joseph Hospital Group with a rating system which determines the indication according to the score. Teaching this new method of analyzing pelvic ring fractures would simplify decision making between surgical and functional treatment.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date April 26, 2022
Est. primary completion date February 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient aged> 18 years - Patient treated or followed within the Orthopedic Surgery service of the GHPSJ for a pelvic ring fracture - complete initial imaging patient record (scanner) - French speaking patient Exclusion Criteria: - Patients under guardianship or curatorship - Patients deprived of their liberty - Patients objecting to the use of their data for this research - Patient with isolated sacral or acetabular fracture - Absence of scanner during the initial assessment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Groupe Hospitalier Paris Saint-Joseph Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary State of play of the decision for surgical sanction of pelvic ring fractures This corresponds to the number of patients for whom surgical decisions have been made. Day 1
Secondary Impact of the teaching of the new method of analysis on the surgical decision within each group This corresponds to the number of files for which surgical decision-making was modified before and after teaching of the new method of analysis. Day 1
Secondary Reproducibility of this intra and inter-group decision before and after teaching This corresponds to the number of files for which surgical decision-making was modified before and after teaching of the new method of analysis in intra and inter-group. Day 1
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