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Clinical Trials in France / NCT04246944
Recruiting Not applicable

Induced Membrane Properties in Children and Adults

NCT04246944 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Not applicable
Started
2019-05-23
Last updated
2025-06-08

Condition(s) studied

Bone LossSurgery

Investigational drug(s) / intervention(s)

harvesting induced membrane

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

Study 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.

Eligibility

Sex
ALL
Min age
9 Months
Max age
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.

Primary outcome measure(s)

  • Measure of the BMP2 concentration of the induced membrane by immunodetection — one year (one year from day of surgery)
    Measure of the osteogenic property of the induced membrane will be made after harvesting the induced membrane

Trial sites (1)

FacilityCityRegionStatus
CHU Amiens Amiens France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04246944 on ClinicalTrials.gov ↗ ← All trials in France