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NCT Number: NCT04883502

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

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.

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital d'Instruction des Armées Percy, Clamart, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample collection

Biological

A blood sample will be collected at enrollment.

Other biological sample collection

Biological

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 collection

Diagnostic Test

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

Radiological examination and functional exploration

Diagnostic Test

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laurent MATHIEU, MD, PhD

CONTACT

[email protected]

141466157 ext. +33

Marjorie DURAND, PhD

CONTACT

[email protected]

178651146 ext. +33

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Acronym: MEMBRAN

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 12, 2021
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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