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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04883502
Acronym
MEMBRAN
Enrollment
80
Registered
2021-05-12
Start date
2021-10-29
Completion date
2028-04-30
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss

Keywords

Masquelet technique, Induced membrane technique

Brief 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.

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

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Histological profile of induced membrane fragmentsThrough study completion, an average of 6,5 yearsPresence of abnormalities in the organization of connective fibers. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Cellular profile of induced membrane fragmentsThrough study completion, an average of 6,5 yearsPresence of mesenchymal stromal cells, ability of these cells to differentiate into osteoblasts, presence of other cell types (such as adipocytes and osteoclasts). The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Secretory profile of induced membrane fragmentsThrough study completion, an average of 6,5 yearsDetermination of proteins secreted by the induced membrane fragments by mass spectrometry or by enzyme-linked immunosorbent assay. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.
Gene expression profile of induced membrane fragmentsThrough study completion, an average of 6,5 yearsExpression of several genes of interest related to angiogenesis, mesenchymal stromal cells mobilization, bone formation or resorption and extracellular matrix remodeling. The profile of induced membrane fragments will be compared between patients who respond and patients who do not respond to the induced membrane technique.

Countries

France

Contacts

Primary ContactMarjorie DURAND, PhD
marjorie1.durand@intradef.gouv.fr178651146
Backup ContactLaurent MATHIEU, MD, PhD
laurent-m2.mathieu@intradef.gouv.fr141466157

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026