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EMIH: Induced Membrane Properties in Children and Adults

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04246944
Collaborator
(none)
50
Enrollment
1
Location
120
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: harvesting induced membrane
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Induced Membrane Properties in Children and Adults
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Jan 1, 2030
Anticipated Study Completion Date :
Jan 1, 2030

Outcome Measures

Primary Outcome Measures

  1. Measure of the BMP2 concentration of the induced membrane by immunodetection [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 Outcome Measures

  1. BMP2 concentration of the induced membrane implanted in adults measured by immunodetection [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 [one year (one year from day of surgery)]

    measurement of osteogenic property of the induced membrane in children

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Months to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Céline Klein, MD, CHU Amiens

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04246944
Other Study ID Numbers:
  • PI2018_843_0041
First Posted:
Jan 29, 2020
Last Update Posted:
Jan 29, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
induced membrane
critical size defect

Study Results

No Results Posted as of Jan 29, 2020