Septic Tibial Non-unionSEPT-LEGNCT03940638
Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique
An observational study of Septic Tibial Non-union, run by CHU de Reims at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Tibial Non-union
- What is being tested?
- Data collection
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with septic non-union of the tibia managed using the induced membrane technique
Who may be able to join
- 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
Who cannot join
- Patient under law protection
- Minor patient
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Septic Tibial Non-union
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| Patients with septic non-union of the tibia | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startSep 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic Tibial Non-unionStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940638
- Sponsor's protocol ID
- 2018Ao002
- Acronym
- SEPT-LEG
- Status last verified
- May 2019
- First submitted
- 6 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.2018.04.013. Epub 2018 Jun 7.
PubMed 29886150
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Septic Non-union of the Tibia Using the "Induced Membrane" Technique
- ClinicalTrials.gov ID
- NCT03940638
- Acronym / sponsor ID
- SEPT-LEG / 2018Ao002
- Conditions
- Septic Tibial Non-union
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with septic non-union of the tibia | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with septic non-union of the tibia managed using the induced membrane technique
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient under law protection
- Minor patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionData collection | Other | Patients with septic non-union of the tibia |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Results publication: PubMed 29886150Siboni 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.2018.04.013. Epub 2018 Jun 7.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Tibial Non-union, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Bone union (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.