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Induced Membrane Properties in Children and Adults (EMIH)

C

Centre Hospitalier Universitaire, Amiens

Status

Enrolling

Conditions

Surgery
Bone Loss

Treatments

Procedure: harvesting induced membrane

Study type

Interventional

Funder types

Other

Identifiers

NCT04246944
PI2018_843_0041

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

9 months to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Céline Klein, MD

Data sourced from clinicaltrials.gov

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