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

ConditionBone Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDirection Centrale du Service de Santé des Armées

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sample collection

    Biological/Vaccine

    A blood sample will be collected at enrollment.

  • Other biological sample collection

    Biological/Vaccine

    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

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 6,5 years
2

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.

Time frame
Through study completion, an average of 6,5 years
3

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.

Time frame
Through study completion, an average of 6,5 years
4

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.

Time frame
Through study completion, an average of 6,5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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