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

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sample collection: A blood sample will be collected at enrollment.

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

Surgical waste collection: The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.

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

Study 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

Primary outcome measure(s)

• 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.

Trial sites (2)

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