Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs (MEMBRAN)

Direction Centrale du Service de Santé des Armées

Status: Enrolling

Conditions: Bone Loss

Treatments: Biological: Blood sample collection; Biological: Other biological sample collection; Diagnostic Test: Radiological examination and functional exploration; Diagnostic Test: Surgical waste collection

Study type: Observational

Funder types: Other

Identifiers

NCT04883502

2021-A00561-40 (Other Identifier)

2019PPRC03

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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