NCT04883502

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Loss

Interventions

Type	Name	Description
BIOLOGICAL	Blood sample collection	A blood sample will be collected at enrollment.
BIOLOGICAL	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
DIAGNOSTIC_TEST	Surgical waste collection	The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2021-10-29
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2021-05-12
• Last updated: 2022-12-21

Locations

2 sites across 1 country: France