Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique (SEPT-LEG)

May 7, 2019 updated by: CHU de Reims
The aim of the study was to assess clinical and radiological results with the "induces membrane" technique, described by A. C. Masquelet in 1986, in a series of patients with septic non-union of the tibia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Septic tibial non-union is a therapeutic challenge that may even lead to amputation. Treatment often necessitates several chirurgical steps. It is agreed that resection must extend to several tissues (osteitis zone ans macroscopically pathological soft tissue), with associated non-union site stabilization ans effective antibiotic therapy.

In 1986, Pr A. C. Masquelet described a 2-step procedure called the induced membrane technique, to manage bone defects of varying severity. Initial results were encouraging but there have been few large homogeneous series specific to this technique in septic non-union.

Study Type

Observational

Enrollment (Actual)

18

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
      • Reims, France, 51092
        • CHU Reims

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with septic non-union of the tibia managed using the induced membrane technique

Description

inclusion criteria :

  • Patients with septic non-union of the tibia
  • managed using the induced membrane technique between novembrer 2007 and novembre 2014 in Reims University hospital
  • Patients who agree to participate to the study
  • Major patient

exclusion criteria :

  • Patient under law protection
  • Minor patient

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with septic non-union of the tibia
Other: Data collection
Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Bone union
Time Frame: Day 0
Bone union was defined by 2 continuous cortices on 2 views (radiologic images comprising 2 perpendicular views of the affected segment)
Day 0

Collaborators and Investigators

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

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2018Ao002

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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