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Study of the Biomechanical and Histological Properties of Septal, Auricular, and Costal Cartilage in the Context of Optimizing Total Nasal Reconstruction (Biom-CARTHIS)

16 de julho de 2026 atualizado por: Hôpital NOVO
The purpose of the study is to understand the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and to identify them histologically.

Visão geral do estudo

Descrição detalhada

Current state of knowledge on the biomechanical properties of human nasal cartilage - implications for tissue engineering and reconstructive surgery

  1. Introduction and clinical context Nasal defects, whether of traumatic, tumoral, dermatological, or congenital origin, constitute a major disfigurement with significant physical and psychosocial repercussions. Nasal reconstruction traditionally relies on autologous grafts - septal, auricular, or costal cartilage - but this approach is limited by donor site morbidity, tissue availability, and the risk of graft failure. Existing alloplastic materials (silicone, Gore-Tex, Medpor high-density polyethylene) exhibit high rates of extrusion and infection, primarily due to mechanical incompatibility with the native tissue. The development of tissue-engineered substitutes thus constitutes a response to an unmet clinical need, provided that precise biomechanical data on the tissues to be replaced are available.
  2. Structure and Histology of Cartilages Used in Nasal Reconstruction 2.1 Nasal Cartilage

    The nose is composed of three main cartilages:

    The septal cartilage: the central supporting structure of the entire nasal pyramid, directly adjacent to the nasal bones posteriorly. It includes the quadrangular cartilage anteriorly and the vomer elements posteriorly.

    The alar cartilages (medial and lateral): mobile structures ensuring the patency of the nasal openings and maintaining the tip of the nose. The superior lateral cartilages: constituting the middle third of the nasal pyramid, and contributing to the stability of the dorsum.

    Histologically, all nasal cartilages are of the hyaline type:

    chondrocytes regularly distributed in an extracellular matrix (ECM) rich in type II collagen, glycosaminoglycans (GAGs), and proteoglycans, without elastic fibers. Septal cartilage has a higher cell density and a higher content of GAGs and proteoglycans than the alar and lateral cartilages, which contributes to its mechanical superiority.

    2.2 Auricular Cartilage Auricular cartilage is an elastic cartilage, structurally distinct from the nasal cartilage. Its extracellular matrix is rich in elastic fibers distributed throughout the tissue, as confirmed by EVG staining positive in all regions of the auricle. This elastic nature gives it elastic recovery properties and dynamic behavior fundamentally different from those of nasal hyaline cartilage. 2.3 Costal cartilage Costal cartilage is of the hyaline type, sharing with septal cartilage an organization around a type II collagen network. It differs from it however by a denser architecture, a different matrix content, and a tendency to progressive warping after surgery, a manifestation of a mechanical creep behavior not captured by simple elastic modulus measurements.

  3. Available Biomechanical Data on Human Nasal Cartilage 3.1 Studies on Living Surgical Tissue Studies conducted the first mechanical study on living septal tissue (45 specimens from reconstructive surgery, patients aged 15 to 60 years). Under confined compression, they measured a balance modulus and hydraulic permeability, and demonstrated that the balance modulus decreases significantly with age (p < 0.01), in parallel with a reduction in GAG content. However, this study has two major limitations in light of current needs: it is limited to septal cartilage only, without specifying the anatomical region of sampling (anterior or posterior), and does not include auricular or costal cartilage. Therefore, no comparison between the different donor sites used in nasal reconstruction is possible.

    Studies analyzed the tensile properties of the human septum in 55 specimens from 28 surgical patients. They confirmed the tensile isotropy of the septum (no significant difference according to axis, age, or sex), with a stability modulus of 3.01 ± 0.39 MPa and a dynamic modulus of 4.99 ± 0.49 MPa. Again, the study was limited to the septum alone, without regional mapping or comparison with other donor sites.

    Studies complement this analysis in confined compression of the living septum and reveal compressive anisotropy: the aggregate modulus is significantly higher in the vertical (0.70 ± 0.12 MPa) and caudal-cranial (0.66 ± 0.01 MPa) orientations than in the medial orientation (0.44 ± 0.04 MPa, p = 0.05). This compressive anisotropy, contrasting with tensile isotropy, reflects the organization of collagen fibers. The study remains however limited to the septum alone and does not provide information on other cartilages used in reconstruction.

    A study was the first to mechanically test the inferior and superior lateral alar cartilages in humans in an intraoperative setting (5 patients undergoing septorhinoplasty). The tensile modulus of elasticity showed considerable variability: inferior alar cartilages 1.82-15.28 MPa, superior lateral cartilages 5.43-28.63 MPa, and septum 4.82-32.76 MPa. The very small sample size (n = 5) and the lack of formal statistical analysis are the main limitations of this pioneering work, which did not include auricular or costal cartilage.

    3.2 Studies on cadaveric tissue

    A study about nasal cartilage perform the most complete biomechanical mapping of human nasal cartilages to date, on 15 fresh-frozen male cadavers (mean age 56 ± 15 years), covering 26 anatomical points by indentation (Mach-1, indenter 0.2 mm, 300 g at 1 mm/s, relaxation 15 min). The Young's moduli in compression are as follows:

    Cartilage | Young's Modulus (MPa) Posterior septal 3.47 ± 0.26 Medial septal 2.74 ± 0.37 Anterior septal 2.50 ± 0.32 Lateral alar 2.12 ± 0.50 Medial alar 2.06 ± 0.50 Superior lateral 0.98 ± 0.29 The posterior septum is significantly stiffer than the anterior septum (p < 0.01), a gradient explained by its proximity to the nasal bones. The alar cartilages, although less stiff in raw modulus, are structurally stiffer than the septal cartilages when corrected for thickness (p < 0.05), due to their arched architecture. This study does not, however, include auricular or costal cartilage. Another study about auricular cartilage performed the same mapping on the auricle (15 cadavers, 14 anatomical points). The compressive moduli are: concha 2.08 ± 0.70 MPa, antitragus 1.79 ± 0.56 MPa, antihelix 1.71 ± 0.63 MPa, tragus 1.67 ± 0.61 MPa, helix 1.41 ± 0.67 MPa. The concha exhibits the highest modulus (p < 0.01 vs. helix). Histological analysis confirms the homogeneous elastic nature of the entire auricle. This study does not include nasal or costal cartilage, and no direct comparison between donor sites is made.

    A study made a methodological advance by modeling the nonlinear and strain-rate-dependent behavior of the three human nasal cartilages (cadaveric tissue, unconfined compression up to 32% strain). They demonstrate that linear models used in previous studies underestimate the actual physiological strain properties and provide hyperelastic and biphasic constitutive parameters for scaffold design. No auricular or costal cartilage is included. A most recent study on cadaveric tissue, simultaneously characterize the septum, superior lateral cartilage (ULC), and inferior lateral cartilage (LLC) in tension, compression, and ECM composition (collagen I, II, III, GAG, pyridinoline). The septum is the most hyaline (collagen II dominant), with a superior aggregate modulus and fracture resistance.

    This study does not include auricular or costal cartilage.

  4. What is missing from the literature Analysis of all available data reveals a central and unresolved gap: no study to date has compared, using fresh, hydrated living tissue and an identical standardized mechanical protocol, the biomechanical properties of the different cartilages actually used together in nasal reconstructive surgery-namely, the septal cartilage (distinguishing its anterior/quadrangular and posterior/vomerine anatomical regions), the auricular conchal cartilage, and the costal cartilage.

    More specifically:

    Studies using living tissue are each limited to a single type of cartilage, without inter-site comparisons and without precise regional mapping of the septum. Cadaveric studies provide detailed anatomical maps, but on non-living, frozen tissue, which can alter the intrinsic mechanical properties, and never compare the three donor sites in the same study with the same protocol.

    No study has mechanically characterized the costal cartilage in relation to the nasal and auricular cartilages from the perspective of comparative nasal reconstruction.

  5. Implications for Substitute Materials The mean Young's modulus of human nasal cartilage under compression is around 2.72 ± 0.63 MPa for the septum, 2.09 ± 0.81 MPa for the alar cartilages, and 0.98 ± 0.29 MPa for the lateral cartilage. For comparison, Medpor has a modulus of approximately 150-300 MPa, a difference of two orders of magnitude. This mechanical mismatch generates micromovements at the implant-skin interface, contributing to extrusion. These data constitute the benchmark against which synthetic substitutes and tissue-engineered constructs should be developed and evaluated.

Tipo de estudo

Observacional

Inscrição (Estimado)

33

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Île-de-France Region
      • Pontoise, Île-de-France Region, França, 95300

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult patients who have undergone septoplasty, rhinoseptoplasty, or otoplasty, and in whom excess cartilage was removed during the surgical procedure.

This cartilage, usually destined for disposal as surgical waste, is collected with the patient's consent, in accordance with current ethical and regulatory guidelines.

Descrição

Inclusion Criteria:

  • Adult patients who have undergone septoplasty, rhinoseptoplasty, or otoplasty, and in whom excess cartilage was removed during the surgical procedure.

This cartilage, usually destined for disposal as surgical waste, is collected with the patient's consent, in accordance with current ethical and regulatory guidelines.

Exclusion Criteria:

  • Patient refusal

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Patients
Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.
Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Structural Histological Features of Septal, Costal, and Auricular Cartilage
Prazo: Through study completion, an average of one year
Structural analysis of cartilage architecture (e.g., chondrocyte distribution/density, extracellular matrix organization, perichondrium integrity) performed ex vivo on surgical waste tissue samples by histological staining, compared across the three cartilage types. No measurement is performed on participants in vivo.
Through study completion, an average of one year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Young's Modulus of Septal, Costal, and Auricular Cartilage
Prazo: Through study completion, an average of one year
Young's modulus (MPa) measured ex vivo on cartilage tissue discarded as surgical waste, to generate a biomechanical stiffness mapping by cartilage type. No measurement is performed on participants in vivo.
Through study completion, an average of one year
Young's Modulus of Cartilage by Type, Patient Age, and Sex
Prazo: Through study completion, an average of 1 year
Comparison of Young's modulus (MPa) values, measured ex vivo on discarded cartilage samples, stratified by cartilage type, patient age, and sex, to establish biomechanical reference data for future biomaterial development.
Through study completion, an average of 1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Khaled AL TABAA, Hopital NOVO
  • Investigador principal: Emmanuel PAUTHE, CY Paris Université

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de agosto de 2026

Conclusão do estudo (Estimado)

1 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

19 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de julho de 2026

Primeira postagem (Real)

21 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • CHRD 0126

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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