MEMBRAN: Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Patient with traumatic bone loss
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Patient eligible for the induced membrane technique
Exclusion Criteria:
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Patients with post-tumor bone loss
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Patients who are immunocompromised or under immunosuppressive treatment
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Patients with chronic inflammatory disease (diabetes, inflammatory bowel disease)
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Patients with collagenosis
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Patient with a contraindication to sampling
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Pregnant or breastfeeding women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital d'Instruction des Armées Percy | Clamart | France | 92140 | |
| 2 | Hôpital d'Instruction des Armées Bégin | Saint-Mandé | France | 94160 |
Sponsors and Collaborators
- Direction Centrale du Service de Santé des Armées
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019PPRC03
- 2021-A00561-40