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

Recruiting

• Conditions: Bone Loss

• Registration Number: NCT04883502
• Lead Sponsor: Direction Centrale du Service de Santé des Armées

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Study Start: 2021-10-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cellular profile of induced membrane fragments	Through study completion, an average of 6,5 years	Presence of mesenchymal stromal cells, ability of these cells to differentiate into osteoblasts, presence of other cell types (such as adipocytes and osteoclasts).; The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Histological profile of induced membrane fragments	Through study completion, an average of 6,5 years	Presence of abnormalities in the organization of connective fibers. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Secretory profile of induced membrane fragments	Through study completion, an average of 6,5 years	Determination of proteins secreted by the induced membrane fragments by mass spectrometry or by enzyme-linked immunosorbent assay.; The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Gene expression profile of induced membrane fragments	Through study completion, an average of 6,5 years	Expression of several genes of interest related to angiogenesis, mesenchymal stromal cells mobilization, bone formation or resorption and extracellular matrix remodeling.; The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.

Trial Locations

Locations (2)

Hôpital d'Instruction des Armées Percy; 🇫🇷 Clamart, France

Hôpital d'Instruction des Armées Bégin; 🇫🇷 Saint-Mandé, France