NCT04217499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2022

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

28 days

First QC Date

December 31, 2019

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Impact of the teaching of the new method of analysis on the surgical decision within each group

    Day 1

  • Reproducibility of this intra and inter-group decision before and after teaching

    Day 1

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Guillaume RIOUALLON, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 3, 2020

Study Start

January 31, 2020

Primary Completion

February 28, 2020

Study Completion

April 26, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations