Induced Membrane Properties in Children and Adults (EMIH)

March 21, 2023 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year (one year from day of surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year (one year from day of surgery)
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
one year (one year from day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Céline Klein, MD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

January 1, 2030

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2018_843_0041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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