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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00561-40 | Other Identifier | IDRCB |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Biological | A blood sample will be collected at enrollment. | ||
| Other biological sample collection | Biological | The following biological samples will be collected during the first surgery:
| ||
| Surgical waste collection | Diagnostic Test | The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery. | ||
| Radiological examination and functional exploration | Diagnostic Test | A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjorie DURAND, PhD | Contact | 178651146 | +33 | marjorie1.durand@intradef.gouv.fr |
| Laurent MATHIEU, MD, PhD | Contact | 141466157 | +33 | laurent-m2.mathieu@intradef.gouv.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Instruction des Armées Percy | Recruiting | Clamart | 92140 | France |
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| Hôpital d'Instruction des Armées Bégin | Recruiting | Saint-Mandé | 94160 | France |
|
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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