Induced Membrane Properties in Children and Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-60
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • harvesting induced membrane

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
one year (one year from day of surgery)

Secondary outcomes

1

BMP2 concentration of the induced membrane implanted in adults measured by immunodetection

measurement of osteogenic property of the induced membrane in adults

Time frame
one year (one year from day of surgery)
2

BMP2 concentration of the induced membrane implanted in children measured by immunodetection

measurement of osteogenic property of the induced membrane in children

Time frame
one year (one year from day of surgery)

Other outcomes

Sponsors and contacts

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