Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
MEMBRAN
2 other identifiers
observational
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 12, 2021
CompletedStudy Start
First participant enrolled
October 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
December 21, 2022
December 1, 2022
6.4 years
April 28, 2021
December 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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
Interventions
A blood sample will be collected at enrollment.
The following biological samples will be collected during the first surgery: * 1 blood sample * 3 fragments of induced membrane * 1 fragment of periosteum
The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.
A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery
Eligibility Criteria
The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.
You may qualify if:
- Age ≥ 18 years
- Patient with traumatic bone loss
- Patient eligible for the induced membrane technique
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hôpital d'Instruction des Armées Percy
Clamart, 92140, France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160, France
Biospecimen
* 1 blood sample * 3 fragments of induced membrane * 1 fragment of periosteum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 12, 2021
Study Start
October 29, 2021
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
December 21, 2022
Record last verified: 2022-12