- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217499
Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm (BASSINJO)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with pelvic ring fractures
This retrospective study will be carried out on the data of patients who have received treatment or followed for a pelvic ring fracture, in the Orthopedic Surgery department of the Paris Saint-Joseph Hospital Group between January 2015 and September 2019.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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State of play of the decision for surgical sanction of pelvic ring fractures
Time Frame: Day 1
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This corresponds to the number of patients for whom surgical decisions have been made.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the teaching of the new method of analysis on the surgical decision within each group
Time Frame: Day 1
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This corresponds to the number of files for which surgical decision-making was modified before and after teaching of the new method of analysis.
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Day 1
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Reproducibility of this intra and inter-group decision before and after teaching
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASSINJO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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