RecruitingNCT04883502

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


Sponsor

Direction Centrale du Service de Santé des Armées

Enrollment

80 participants

Start Date

Oct 29, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥ 18 years
  • Patient with traumatic bone loss
  • Patient eligible for the induced membrane technique

Exclusion Criteria6

  • 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

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Interventions

BIOLOGICALBlood sample collection

A blood sample will be collected at enrollment.

BIOLOGICALOther 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

DIAGNOSTIC_TESTSurgical waste collection

The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.

DIAGNOSTIC_TESTRadiological 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


Locations(2)

Hôpital d'Instruction des Armées Percy

Clamart, France

Hôpital d'Instruction des Armées Bégin

Saint-Mandé, France

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NCT04883502


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