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Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs

NCT ID: NCT04883502

Last Updated: 2022-12-21

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

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-29

Study Completion Date

2028-04-30

Brief Summary

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Masquelet's induced membrane technique is a two-stage reconstructive surgery for severe bone fractures commonly used by military orthopedists. The particularity of this technique relies on the synthesis of a biological membrane induced by the transient implantation of a surgical cement (= 1st stage surgery). The presence of the induced membrane in the reconstruction space defines a microenvironment or "biological chamber" favourable to osteogenesis, positively influencing the repair of the lesion after implantation of an autologous bone graft (= 2nd stage of surgery).

In view of the excellent clinical results obtained with this procedure, the Masquelet technique has gradually become a reference treatment in the field of orthopedic and trauma surgery.

However, orthopedic surgeons sometimes observe failures in bone consolidation. To our knowledge, the role played by induced membrane in these therapeutic failures has never been studied.

Detailed Description

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Conditions

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Bone Loss

Keywords

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Masquelet technique Induced membrane technique

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sample collection

A blood sample will be collected at enrollment.

Intervention Type BIOLOGICAL

Other biological sample collection

The following biological samples will be collected during the first surgery:

* 1 blood sample
* 3 fragments of induced membrane
* 1 fragment of periosteum

Intervention Type BIOLOGICAL

Surgical waste collection

The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.

Intervention Type DIAGNOSTIC_TEST

Radiological examination and functional exploration

A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patient with traumatic bone loss
* Patient eligible for the induced membrane technique

Exclusion Criteria

* Patients with post-tumor bone loss
* Patients who are immunocompromised or under immunosuppressive treatment
* Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)
* Patients with collagenosis
* Patient with a contraindication to sampling
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Direction Centrale du Service de Santé des Armées

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital d'Instruction des Armées Percy

Clamart, , France

Site Status RECRUITING

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marjorie DURAND, PhD

Role: CONTACT

Phone: 178651146

Email: [email protected]

Laurent MATHIEU, MD, PhD

Role: CONTACT

Phone: 141466157

Email: [email protected]

Facility Contacts

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Laurent MATHIEU, MD, PhD

Role: primary

Thomas DEMOURES, MD

Role: primary

Other Identifiers

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2021-A00561-40

Identifier Type: OTHER

Identifier Source: secondary_id

2019PPRC03

Identifier Type: -

Identifier Source: org_study_id