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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04883502
Other study ID # 2019PPRC03
Secondary ID 2021-A00561-40
Status Recruiting
Phase
First received
Last updated
Start date October 29, 2021
Est. completion date April 2028

Study information

Verified date December 2022
Source Direction Centrale du Service de Santé des Armées
Contact Marjorie DURAND, PhD
Phone 178651146
Email marjorie1.durand@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 2028
Est. primary completion date April 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood sample collection
A blood sample will be collected at enrollment.
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.
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

Locations

Country Name City State
France Hôpital d'Instruction des Armées Percy Clamart
France Hôpital d'Instruction des Armées Bégin Saint-Mandé

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Histological profile of induced membrane fragments Presence 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. Through study completion, an average of 6,5 years
Primary Cellular profile of induced membrane fragments Presence 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.
Through study completion, an average of 6,5 years
Primary Secretory profile of induced membrane fragments Determination 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.
Through study completion, an average of 6,5 years
Primary Gene expression profile of induced membrane fragments Expression 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.
Through study completion, an average of 6,5 years
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