Induced Membrane Properties in Children and Adults

Surgery Clinical Trial

— EMIH  

Official title:

Induced Membrane Properties in Children and Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246944
• Other study ID #: PI2018_843_0041
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: January 2030

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Céline Klein, MD
• Phone: (33)322087571
• Email: klein.celine[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Months to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss
• Surgery

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the BMP2 concentration of the induced membrane by immunodetection	Measure of the osteogenic property of the induced membrane will be made after harvesting the induced membrane	one year (one year from day of surgery)
Secondary	BMP2 concentration of the induced membrane implanted in adults measured by immunodetection	measurement of osteogenic property of the induced membrane in adults	one year (one year from day of surgery)
Secondary	BMP2 concentration of the induced membrane implanted in children measured by immunodetection	measurement of osteogenic property of the induced membrane in children	one year (one year from day of surgery)