このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年7月16日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

33

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Île-de-France Region
      • Pontoise、Île-de-France Region、フランス、95300

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Structural Histological Features of Septal, Costal, and Auricular Cartilage
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Young's Modulus of Septal, Costal, and Auricular Cartilage
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Khaled AL TABAA、Hopital NOVO
  • 主任研究者:Emmanuel PAUTHE、CY Paris Université

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2026年8月1日

研究の完了 (推定)

2026年8月1日

試験登録日

最初に提出

2026年6月19日

QC基準を満たした最初の提出物

2026年7月16日

最初の投稿 (実際)

2026年7月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月21日

QC基準を満たした最後の更新が送信されました

2026年7月16日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CHRD 0126

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

3
購読する