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OpenTrials
Completed

NCT Number: NCT03940638

Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

Data collection

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: SEPT-LEG

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 7, 2019
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.