Bone LossMEMBRANNCT04883502
Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
An observational study of Bone Loss, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Loss
- What is being tested?
- Blood sample collection, Other biological sample collection and Surgical waste collection
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Oct 2021to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.
Who may be able to join
- Age ≥ 18 years
- Patient with traumatic bone loss
- Patient eligible for the induced membrane technique
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital d'Instruction des Armées Percy
Clamart, 92140
Laurent MATHIEU, MD, PhD, 141466157 ext. +33, laurent-m2.mathieu@intradef.gouv.fr
- Recruiting
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, 94160
Thomas DEMOURES, MD, 140514103 ext. +33, thomas.demoures@intradef.gouv.fr
About this study
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.
- Conditions
- Bone Loss
- Being tested
- Blood sample collection, Other biological sample collection, Surgical waste collection, Radiological examination and functional exploration
- Keywords
- Masquelet technique, Induced membrane technique
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionBiological
A blood sample will be collected at enrollment.
Other biological sample collectionBiological
The following biological samples will be collected during the first surgery:
- 1 blood sample
- 3 fragments of induced membrane
- 1 fragment of periosteum
Surgical waste collectionDiagnostic test
The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.
Radiological examination and functional explorationDiagnostic test
A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 6,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start29 Oct 2021
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883502
- Sponsor's protocol ID
- 2019PPRC03
- Other IDs
- 2021-A00561-40
- Acronym
- MEMBRAN
- Status last verified
- Dec 2022
- First submitted
- 28 Apr 2021
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
- ClinicalTrials.gov ID
- NCT04883502
- Acronym / sponsor ID
- MEMBRAN / 2019PPRC03
- Conditions
- Bone Loss
- Keywords
- Masquelet technique, Induced membrane technique
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patient with traumatic bone loss
- Patient eligible for the induced membrane technique
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionA blood sample will be collected at enrollment. | Biological | – |
| Other biological sample collectionThe following biological samples will be collected during the first surgery: * 1 blood sample * 3 fragments of induced membrane * 1 fragment of periosteum | Biological | – |
| Surgical waste collectionThe pieces of polymethylmethacrylate surgical cement will be collected during the second surgery. | Diagnostic test | – |
| Radiological examination and functional explorationA radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery | Diagnostic test | – |
Primary outcome
Histological profile of induced membrane fragments
Time frame: Through study completion, an average of 6,5 years
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.
Cellular profile of induced membrane fragments
Time frame: Through study completion, an average of 6,5 years
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.
Secretory profile of induced membrane fragments
Time frame: Through study completion, an average of 6,5 years
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.
Gene expression profile of induced membrane fragments
Time frame: Through study completion, an average of 6,5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Loss, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjorie DURAND, PhD (178651146 ext. +33, marjorie1.durand@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological profile of induced membrane fragments (time frame: Through study completion, an average of 6,5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.