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

Septic Tibial Non-union Clinical Trial

— SEPT-LEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940638
• Other study ID #: 2018Ao002
• Status: Completed
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: May 2019
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Tibial Non-union

Intervention

Other:
• Data collection
Data collection

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

References & Publications (1)

Siboni R, Joseph E, Blasco L, Barbe C, Bajolet O, Diallo S, Ohl X. Management of septic non-union of the tibia by the induced membrane technique. What factors could improve results? Orthop Traumatol Surg Res. 2018 Oct;104(6):911-915. doi: 10.1016/j.otsr.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Bone union	Bone union was defined by 2 continuous cortices on 2 views (radiologic images comprising 2 perpendicular views of the affected segment)	Day 0