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

Study Overview
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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.

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

Conditions
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Bone Loss

Intervention / Treatment
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* Biological: Blood sample collection
* Biological: Other biological sample collection
* Diagnostic Test: Surgical waste collection
* Diagnostic Test: Radiological examination and functional exploration


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Blood sample collection|A blood sample will be collected at enrollment.|
|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|
|Diagnostic Test: Surgical waste collection|The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.|
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological profile of induced membrane fragments | 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. | Through study completion, an average of 6,5 years | 
| Cellular profile of induced membrane fragments | 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. | Through study completion, an average of 6,5 years | 
| Secretory profile of induced membrane fragments | 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. | Through study completion, an average of 6,5 years | 
| Gene expression profile of induced membrane fragments | 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. | Through study completion, an average of 6,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Masquelet technique, Induced membrane technique