Induced Membrane Properties in Children and Adults

NCT ID: NCT04246944

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2030-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Loss Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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harvesting induced membrane

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

9 Months

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Céline Klein, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Céline Klein, MD

Role: CONTACT

(33)322087571

Facility Contacts

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Céline Klein, MD

Role: primary

(33)322087571

Other Identifiers

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PI2018_843_0041

Identifier Type: -

Identifier Source: org_study_id

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