An observational study in Bone Loss, sponsored by Direction Centrale du Service de Santé des Armées. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Direction Centrale du Service de Santé des Armées · Observational
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.
487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 107 observational studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Direction Centrale du Service de Santé des Armées is the lead sponsor of 95 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population is composed of patients with traumatic bone loss who are eligible for the induced membrane technique.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 6,5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Apr 2028, 78 months after the start.
Of 38 observational studies under Bone Diseases, Metabolic, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17. This study's planned 78 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Direction Centrale du Service de Santé des Armées