NCT04883502 Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
| NCT ID | NCT04883502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Direction Centrale du Service de Santé des Armées |
| Condition | Bone Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-10-29 |
| Primary Completion | 2028-04 |
Trial Parameters
Eligibility Fast-Check
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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.
Eligibility Criteria
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