Bone LossFIBMASCNCT07825532
Comparison of Induced Membrane Technique With Vascularized Fibula Flap for Pediatric Limb Reconstruction
An observational study of Bone Loss and Microsurgery, run by Central Hospital, Nancy, France.
Trial summary
This study has for goal to evaluate vascularised fibula flap and induced membrane for children's bone loss. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Bone Loss, Microsurgery, Reconstruction
- What is being tested?
- limb reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- Child, Adult
Study population: Children from 0 to 18 years.
Who may be able to join
- Patient under 18 years old
- Procedure by induced membrane or vascularised fibula flap for limb reconstruction from 2000 to 2026
Who cannot join
- Patient under 6 months follow up
- Patient who underwent vascularised fibula flap with epiphysis
About this study
Official title: Comparison of Induced Membrane Technique With Vascularized Fibula Flap for Pediatric Limb Reconstruction, a National French Study
This study has for goal to evaluate vascularised fibula flap and induced membrane for children's bone loss.
- Conditions
- Bone Loss, Microsurgery, Reconstruction, Children, Induced Membrane, Fibula Flap
- Being tested
- limb reconstruction
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limb reconstructionProcedure or surgery
- induced membrane
- vascularised fibula
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete consolidation at 12 months
The measures will be evaluated on x-rays. Consolidation is considerred achieved when at least 3 out of 4 cortices are fused.
Xrays are done on every consultations
Measured: assessment of consolidation 12 months after surgical reconstruction, for induced membrane group the first time of surgery is considerred
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PIESSAT Colin, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825532
- Sponsor's protocol ID
- 2026PI141
- Acronym
- FIBMASC
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Induced Membrane Technique With Vascularized Fibula Flap for Pediatric Limb Reconstruction, a National French Study
- ClinicalTrials.gov ID
- NCT07825532
- Acronym / sponsor ID
- FIBMASC / 2026PI141
- Conditions
- Bone Loss, Microsurgery, Reconstruction, Children, Induced Membrane, Fibula Flap
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Sep 2026 (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.
This study has for goal to evaluate vascularised fibula flap and induced membrane for children's bone loss.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children from 0 to 18 years.
Key inclusion criteria (2 listed)
- Patient under 18 years old
- Procedure by induced membrane or vascularised fibula flap for limb reconstruction from 2000 to 2026
Key exclusion criteria (2 listed)
- Patient under 6 months follow up
- Patient who underwent vascularised fibula flap with epiphysis
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 |
|---|---|---|
| limb reconstruction* induced membrane * vascularised fibula | Procedure or surgery | – |
Primary outcome
Complete consolidation at 12 months
Time frame: assessment of consolidation 12 months after surgical reconstruction, for induced membrane group the first time of surgery is considerred
The measures will be evaluated on x-rays. Consolidation is considerred achieved when at least 3 out of 4 cortices are fused. Xrays are done on every consultations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss and Microsurgery, run by Central Hospital, Nancy, 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 2 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Complete consolidation at 12 months (time frame: assessment of consolidation 12 months after surgical reconstruction, for induced membrane group the first time of surgery is considerred). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.