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

Recruiting now

Conditions studied: Bone Loss

In brief

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.

Key facts

Study ID

NCT04883502

Run by

Direction Centrale du Service de Santé des Armées

People needed

80

Starts

2021-10-29

Expected to finish

2028-04-01

Last updated by the study team

2022-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Hôpital d'Instruction des Armées Percy — Clamart, France (enrolling)
• Hôpital d'Instruction des Armées Bégin — Saint-Mandé, France (enrolling)

Full record on ClinicalTrials.gov

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