Septic Pseudarthrosis Of Long Bone : Experience In A Regional Reference Center

February 15, 2019 updated by: Eugénie MABRUT, Hospices Civils de Lyon
Description of septic pseudarthrosis with chirurgical treatment in two steps (first step : Implementation of cement, second step : bone reconstruction, with or without device)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

: patients having septic pseudarthrosis managed with 2 steps chirurgical treatment

Description

Inclusion Criteria:

  • patients having septic pseudarthrosis of long bone treated at the CRIOAc LYON

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Description of treatment of septic pseudarthrosis
chirurgical and medical treatment
Other: Description of treatment of septic pseudarthrosis
description of chirurgical 2 steps management of septic pseudarthrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of treatment of septic pseudarthrosis : chirurgical treatment - rate of use of this type of chirurgical treatment among patients with septic pseudarthrosis
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Description of treatment of septic pseudarthrosis : chirurgical treatment
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of treatment of septic pseudarthrosis : medical treatment - duration of treatment in patients having sepstic pseudarthrosis
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Description of treatment of septic pseudarthrosis : medical treatment
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Treatment failure : rate of failure with this 2 times chirurgical treatment
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Tristan Ferry, Hospices Civils de Lyon - Hôpital Croix-Rousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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