Induced Membrane Properties in Children and Adults

NCT04246944 | Recruiting

• 1 other identifier: PI2018_843_0041
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Surgery

Keywords

induced membrane; critical size defect

Outcome Measures

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

  one year (one year from day of surgery)

Secondary Outcomes (2)

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

  one year (one year from day of surgery)

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

  one year (one year from day of surgery)

Interventions

harvesting induced membrane PROCEDURE

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

Eligibility Criteria

• Age: 9 Months - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Céline Klein, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline Klein, MD

CONTACT

(33)322087571; klein.celine@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 29, 2020
• Study Start: May 23, 2019
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)