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Study of the Role of the Induced Membrane in the Reconstruction of Bone Loss in the Limbs

NCT04883502 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-12-21

No results posted yet for this study

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.

Conditions

  • Bone Loss

Interventions

BIOLOGICAL

Blood sample collection

A blood sample will be collected at enrollment.

BIOLOGICAL

Other biological sample collection

The following biological samples will be collected during the first surgery: * 1 blood sample * 3 fragments of induced membrane * 1 fragment of periosteum

DIAGNOSTIC_TEST

Surgical waste collection

The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.

DIAGNOSTIC_TEST

Radiological examination and functional exploration

A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery

Sponsors & Collaborators

  • Direction Centrale du Service de Santé des Armées

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883502 on ClinicalTrials.gov