Pelvic FractureBASSINJONCT04217499
Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm
An observational study of Pelvic Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Fracture
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2020to 26 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were hospitalized or consulted in the Orthopedic Surgery service of the Paris Saint-Joseph Hospital Group, for the management of a pelvic ring fracture from January 2015 until September 2019.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Pelvic Fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start31 Jan 2020
- Primary completion28 Feb 2020
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume RIOUALLON, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217499
- Sponsor's protocol ID
- BASSINJO
- Acronym
- BASSINJO
- Status last verified
- Apr 2023
- First submitted
- 31 Dec 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm
- ClinicalTrials.gov ID
- NCT04217499
- Acronym / sponsor ID
- BASSINJO / BASSINJO
- Conditions
- Pelvic Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 3 Jan 2020 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were hospitalized or consulted in the Orthopedic Surgery service of the Paris Saint-Joseph Hospital Group, for the management of a pelvic ring fracture from January 2015 until September 2019.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
State of play of the decision for surgical sanction of pelvic ring fractures
Time frame: Day 1
This corresponds to the number of patients for whom surgical decisions have been made.
2 secondary outcomes
Impact of the teaching of the new method of analysis on the surgical decision within each group
Time frame: Day 1
Reproducibility of this intra and inter-group decision before and after teaching
Time frame: Day 1
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 27 Apr 2023.
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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.
Guillaume RIOUALLON, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 4 inclusion and 5 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
State of play of the decision for surgical sanction of pelvic ring fractures (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.