NCT04418882

Brief Summary

The aim is the study of the management and outcome of the open fractures. Some open fractures will become pseudarthrosis. Thoses pseudarthrosis may be septic or not. The management and evolution of all the open fractures will be described in order to identify the presence or not of a sepsis and then a development of a pseudarthrosis (septic or non septic).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

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

Study Start

First participant enrolled

May 15, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 12, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

June 3, 2020

Last Update Submit

January 11, 2022

Conditions

Open FracturePseudarthrosisBone and Joint Infection

Keywords

bone and joint infectionPseudarthrosisOpen Fracture

Outcome Measures

Primary Outcomes (11)

  • description of non septic open fracture

    description of surgical management

    24 months

  • description of patients with non septic open fracture

    description of patients : average age, medical background

    1 month

  • description of septic open fracture : bacteriology

    type of bacteria involved in the infection

    24 months

  • description of septic open fracture : evolution

    description of symptoms

    24 months

  • description of septic open fracture : management

    description of surgical and medical management

    24 months

  • description of septic open fracture : patients

    description of patients : average age, medical background

    24 months

  • description of pseudarthrosis: symptoms

    description of symptoms

    24 months

  • description of pseudarthrosis : management

    description of management: surgical and medical management

    24 months

  • description of septic pseudarthrosis : patients

    description of patients : average age, medical background

    24 months

  • description of septic pseudarthrosis : bacteriology

    type of bacteria involved in the infection

    24 months

  • treatment failure

    rate and description of treatment failure.Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin

    24 months

Study Arms (2)

non septic open fracture

patients having had an open fracture without septic evolution

Other: management and follow up of all open fractures

septic open fracture

patients having had an open fracture with septic evolution

Other: management and follow up of all open fractures

Interventions

management and follow up of all open fracturesOTHER

to evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too.

non septic open fractureseptic open fracture

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having had an open fractures managed at the HCL

You may qualify if:

  • all patients with open fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Related Links

MeSH Terms

Conditions

Fractures, OpenPseudarthrosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesFractures, Ununited

Study Design

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

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

May 15, 2020

Primary Completion

July 1, 2020

Study Completion

December 1, 2021

Last Updated

January 12, 2022

Record last verified: 2022-01

Locations

FR(1)