NCT04883502 Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs
| NCT ID | NCT04883502 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Direction Centrale du Service de Santé des Armées |
| Condition | Bone Loss |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-10-29 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2021-10-29 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04883502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04883502 currently recruiting?
Yes, NCT04883502 is actively recruiting participants. Contact the research team at marjorie1.durand@intradef.gouv.fr for enrollment information.
Where is the NCT04883502 trial being conducted?
This trial is being conducted at Clamart, France, Saint-Mandé, France.
Who is sponsoring the NCT04883502 clinical trial?
NCT04883502 is sponsored by Direction Centrale du Service de Santé des Armées. The trial plans to enroll 80 participants.