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Induced Membrane Properties in Children and Adults

Induced Membrane Properties in Children and Adults

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04246944
Acronym
EMIH
Enrollment
50
Registered
2020-01-29
Start date
2019-05-23
Completion date
2030-01-31
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Surgery

Keywords

induced membrane, critical size defect

Brief summary

Bone reconstruction in critical sized defect (CSD) remains a real challenge in orthopedic surgery in children and adults. The Masquelet technique is an innovative therapeutic technique, which offers a bone reconstruction in two steps, by the formation of an induced membrane (IM) around a polymethylmethacrylate (PMMA) spacer placed into the bone defect. After, PMMA removal, the cavity is filled with corticocancellous graft allowing bone healing. Up to date, all angiogenesis and osteogenic properties of IM remain unknown. The purpose of this study is to characterize angiogenesis and osteogenic properties of IM in children and adults.

Interventions

PROCEDUREharvesting induced membrane

The induced membrane will be harvested during the second step of the bone reconstruction.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Months to 60 Years
Healthy volunteers
No

Inclusion criteria

* All patients treated at CHU Amiens-Picardie for bone critical sized defect treated using the induced membrane reconstruction technique. * patients from 9 months to 60 years old

Exclusion criteria

* Patients managed by another reconstruction technique for critical sized defect * Patients under guardianship, curators or deprived of liberty. * Pregnant and nursing women. * Patients who refused to participate in the study and to sign informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Measure of the BMP2 concentration of the induced membrane by immunodetectionone year (one year from day of surgery)Measure of the osteogenic property of the induced membrane will be made after harvesting the induced membrane

Secondary

MeasureTime frameDescription
BMP2 concentration of the induced membrane implanted in adults measured by immunodetectionone year (one year from day of surgery)measurement of osteogenic property of the induced membrane in adults
BMP2 concentration of the induced membrane implanted in children measured by immunodetectionone year (one year from day of surgery)measurement of osteogenic property of the induced membrane in children

Countries

France

Contacts

Primary ContactCéline Klein, MD
klein.celine@chu-amiens.fr(33)322087571

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026