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

Bone Loss Clinical Trial

— MEMBRAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04883502
• Other study ID #: 2019PPRC03
• Secondary ID: 2021-A00561-40
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Bone Loss

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