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NCT Number: NCT04246944

Induced Membrane Properties in Children and Adults

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.

Recruiting

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Surgery

Age range

9 month–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

harvesting induced membrane

Procedure

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

Primary outcomes

  1. Measure of the BMP2 concentration of the induced membrane by immunodetection

    Time frame: 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 outcomes

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

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

    measurement of osteogenic property of the induced membrane in adults

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

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

    measurement of osteogenic property of the induced membrane in children

Study contacts

Contact information is provided by the study sponsor or research team.

Céline Klein, MD

CONTACT

[email protected]

(33)322087571

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: EMIH

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jan 29, 2020
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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