Exploring the role of induced membranes in bone reconstruction
Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
Direction Centrale du Service de Santé des Armées · NCT04883502
This study is testing how a special surgical technique that creates a natural membrane can help improve healing in people with severe bone fractures when traditional methods don't work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Direction Centrale du Service de Santé des Armées (other) |
| Locations | 2 sites (Clamart and 1 other locations) |
| Trial ID | NCT04883502 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the Masquelet technique, a two-stage surgical approach used to treat severe bone fractures by creating a biological membrane that enhances bone healing. The first stage involves the implantation of surgical cement to induce a membrane, while the second stage involves the implantation of an autologous bone graft. The study aims to understand the role of this induced membrane in cases where bone consolidation fails, providing insights into improving surgical outcomes. Data will be collected through blood samples, biological samples, surgical waste, and radiological examinations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced traumatic bone loss and are eligible for the Masquelet technique.
Not a fit: Patients with post-tumor bone loss, those who are immunocompromised, or individuals with chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved techniques for bone reconstruction, enhancing healing and reducing complications for patients with traumatic bone loss.
How similar studies have performed: While the Masquelet technique has shown excellent clinical results, the specific investigation into the induced membrane's role in treatment failures is novel and has not been extensively studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clamart and 1 other locations
- Hôpital d'Instruction des Armées Percy — Clamart, France (RECRUITING)
- Hôpital d'Instruction des Armées Bégin — Saint-Mandé, France (RECRUITING)
Study contacts
- Study coordinator: Marjorie DURAND, PhD
- Email: marjorie1.durand@intradef.gouv.fr
- Phone: 178651146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone Loss, Masquelet technique, Induced membrane technique