About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patient with traumatic bone loss
Patient eligible for the induced membrane technique
Disqualifiers
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
Trial population
The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.
Trial design
Cohort
Prospective
Treatments tested in this trial
Blood sample collection
Biological/VaccineA blood sample will be collected at enrollment.
Other biological sample collection
Biological/VaccineThe following biological samples will be collected during the first surgery: * 1 blood sample * 3 fragments of induced membrane * 1 fragment of periosteum
Surgical waste collection
Diagnostic testThe pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.
Radiological examination and functional exploration
Diagnostic testA radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Sponsors and contacts
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