Induced Membrane Properties in Children and Adults

Not Applicable

Recruiting

• Conditions: Bone Loss; Surgery

• Registration Number: NCT04246944
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-08
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
BMP2 concentration of the induced membrane implanted in adults measured by immunodetection	one 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 immunodetection	one year (one year from day of surgery)	measurement of osteogenic property of the induced membrane in children

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France