Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample collection, Other biological sample collection, Surgical waste collection, Radiological examination and functional exploration.
- Who it may be relevant to
- Registry conditions: Bone Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Histological profile of induced membrane fragments [Time frame: Through study completion, an average of 6,5 years]
- Cellular profile of induced membrane fragments [Time frame: Through study completion, an average of 6,5 years]
- Secretory profile of induced membrane fragments [Time frame: Through study completion, an average of 6,5 years]
- Gene expression profile of induced membrane fragments [Time frame: Through study completion, an average of 6,5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Hôpital d'Instruction des Armées Percy — Clamart
- Hôpital d'Instruction des Armées Bégin — Saint-Mandé
Identifiers
NCT: NCT04883502 · 2019PPRC03 · 2021-A00561-40