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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04246944
Other study ID # PI2018_843_0041
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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