SeptoplastyBiom-CARTHISNCT07717138
Study of the Biomechanical and Histological Properties of Septal, Auricular, and Costal Cartilage in the Context of Optimizing Total Nasal Reconstruction
An observational study of Septoplasty and Rhinoseptoplasty, run by Hôpital NOVO at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septoplasty, Rhinoseptoplasty, Rib Grafting
- What is being tested?
- Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hopital NOVO
Pontoise, Île-de-France Region, 95300
Khaled AL TABAA, 0033130754040, khaled.altabaa@ght-novo.fr
About this study
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.
Read the detailed description
Current state of knowledge on the biomechanical properties of human nasal cartilage - implications for tissue engineering and reconstructive surgery
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Septoplasty, Rhinoseptoplasty, Rib Grafting, Otoplasty
- Being tested
- Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.
- Keywords
- Septoplasty, Rhinoseptoplasty, Cartilage, Nasal, Otoplasty, Rib grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.Other
Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification. Receives: Other: Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural Histological Features of Septal, Costal, and Auricular Cartilage
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.
Measured: Through study completion, an average of one year
Secondary outcomes (2)
Young's Modulus of Septal, Costal, and Auricular Cartilage
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.
Measured: Through study completion, an average of one year
Young's Modulus of Cartilage by Type, Patient Age, and Sex
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SeptoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled AL TABAA, Principal investigator, Hôpital NOVOEmmanuel PAUTHE, Principal investigator, CY Paris Université
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717138
- Sponsor's protocol ID
- CHRD 0126
- Acronym
- Biom-CARTHIS
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griffin MF, Premakumar Y, Seifalian AM, Szarko M, Butler PE. Biomechanical characterisation of the human nasal cartilages; implications for tissue engineering. J Mater Sci Mater Med. 2016 Jan;27(1):11. doi: 10.1007/s10856-015-5619-8. Epub 2015 Dec 16.
PubMed 26676857Griffin MF, Premakumar Y, Seifalian AM, Szarko M, Butler PE. Biomechanical Characterisation of the Human Auricular Cartilages; Implications for Tissue Engineering. Ann Biomed Eng. 2016 Dec;44(12):3460-3467. doi: 10.1007/s10439-016-1688-1. Epub 2016 Jul 14.
PubMed 27417940Gunter JP, Clark CP, Friedman RM. Internal stabilization of autogenous rib cartilage grafts in rhinoplasty: a barrier to cartilage warping. Plast Reconstr Surg. 1997 Jul;100(1):161-9. doi: 10.1097/00006534-199707000-00026.
PubMed 9207674Rotter N, Tobias G, Lebl M, Roy AK, Hansen MC, Vacanti CA, Bonassar LJ. Age-related changes in the composition and mechanical properties of human nasal cartilage. Arch Biochem Biophys. 2002 Jul 1;403(1):132-40. doi: 10.1016/S0003-9861(02)00263-1.
PubMed 12061810Richmon JD, Sage AB, Wong VW, Chen AC, Pan C, Sah RL, Watson D. Tensile biomechanical properties of human nasal septal cartilage. Am J Rhinol. 2005 Nov-Dec;19(6):617-22.
PubMed 16402652Richmon JD, Sage A, Wong WV, Chen AC, Sah RL, Watson D. Compressive biomechanical properties of human nasal septal cartilage. Am J Rhinol. 2006 Sep-Oct;20(5):496-501. doi: 10.2500/ajr.2006.20.2932.
PubMed 17063745Westreich RW, Courtland HW, Nasser P, Jepsen K, Lawson W. Defining nasal cartilage elasticity: biomechanical testing of the tripod theory based on a cantilevered model. Arch Facial Plast Surg. 2007 Jul-Aug;9(4):264-70. doi: 10.1001/archfaci.9.4.264.
PubMed 17638761Chang B, Reighard C, Flanagan C, Hollister S, Zopf D. Evaluation of human nasal cartilage nonlinear and rate dependent mechanical properties. J Biomech. 2020 Feb 13;100:109549. doi: 10.1016/j.jbiomech.2019.109549. Epub 2019 Nov 29.
PubMed 31926590Brown WE, Lavernia L, Bielajew BJ, Hu JC, Athanasiou KA. Human nasal cartilage: Functional properties and structure-function relationships for the development of tissue engineering design criteria. Acta Biomater. 2023 Sep 15;168:113-124. doi: 10.1016/j.actbio.2023.07.011. Epub 2023 Jul 16.
PubMed 37454708
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Biomechanical and Histological Properties of Septal, Auricular, and Costal Cartilage in the Context of Optimizing Total Nasal Reconstruction
- ClinicalTrials.gov ID
- NCT07717138
- Acronym / sponsor ID
- Biom-CARTHIS / CHRD 0126
- Conditions
- Septoplasty, Rhinoseptoplasty, Rib Grafting, Otoplasty
- Keywords
- Septoplasty, Rhinoseptoplasty, Cartilage, Nasal, Otoplasty, Rib grafting
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Current state of knowledge on the biomechanical properties of human nasal cartilage - implications for tissue engineering and reconstructive surgery
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients |
Primary outcome
Structural Histological Features of Septal, Costal, and Auricular Cartilage
Time frame: 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.
2 secondary outcomes
Young's Modulus of Septal, Costal, and Auricular Cartilage
Time frame: Through study completion, an average of one year
Young's Modulus of Cartilage by Type, Patient Age, and Sex
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 26676857Griffin MF, Premakumar Y, Seifalian AM, Szarko M, Butler PE. Biomechanical characterisation of the human nasal cartilages; implications for tissue engineering. J Mater Sci Mater Med. 2016 Jan;27(1):11. doi: 10.1007/s10856-015-5619-8. Epub 2015 Dec 16.
- Background: PubMed 27417940Griffin MF, Premakumar Y, Seifalian AM, Szarko M, Butler PE. Biomechanical Characterisation of the Human Auricular Cartilages; Implications for Tissue Engineering. Ann Biomed Eng. 2016 Dec;44(12):3460-3467. doi: 10.1007/s10439-016-1688-1. Epub 2016 Jul 14.
- Background: PubMed 9207674Gunter JP, Clark CP, Friedman RM. Internal stabilization of autogenous rib cartilage grafts in rhinoplasty: a barrier to cartilage warping. Plast Reconstr Surg. 1997 Jul;100(1):161-9. doi: 10.1097/00006534-199707000-00026.
- Background: PubMed 12061810Rotter N, Tobias G, Lebl M, Roy AK, Hansen MC, Vacanti CA, Bonassar LJ. Age-related changes in the composition and mechanical properties of human nasal cartilage. Arch Biochem Biophys. 2002 Jul 1;403(1):132-40. doi: 10.1016/S0003-9861(02)00263-1.
- Background: PubMed 16402652Richmon JD, Sage AB, Wong VW, Chen AC, Pan C, Sah RL, Watson D. Tensile biomechanical properties of human nasal septal cartilage. Am J Rhinol. 2005 Nov-Dec;19(6):617-22.
- Background: PubMed 17063745Richmon JD, Sage A, Wong WV, Chen AC, Sah RL, Watson D. Compressive biomechanical properties of human nasal septal cartilage. Am J Rhinol. 2006 Sep-Oct;20(5):496-501. doi: 10.2500/ajr.2006.20.2932.
- Background: PubMed 17638761Westreich RW, Courtland HW, Nasser P, Jepsen K, Lawson W. Defining nasal cartilage elasticity: biomechanical testing of the tripod theory based on a cantilevered model. Arch Facial Plast Surg. 2007 Jul-Aug;9(4):264-70. doi: 10.1001/archfaci.9.4.264.
- Background: PubMed 31926590Chang B, Reighard C, Flanagan C, Hollister S, Zopf D. Evaluation of human nasal cartilage nonlinear and rate dependent mechanical properties. J Biomech. 2020 Feb 13;100:109549. doi: 10.1016/j.jbiomech.2019.109549. Epub 2019 Nov 29.
- Background: PubMed 37454708Brown WE, Lavernia L, Bielajew BJ, Hu JC, Athanasiou KA. Human nasal cartilage: Functional properties and structure-function relationships for the development of tissue engineering design criteria. Acta Biomater. 2023 Sep 15;168:113-124. doi: 10.1016/j.actbio.2023.07.011. Epub 2023 Jul 16.
- Individual participant dataSharing planned: No
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Deviated Nasal Septum, Postoperative Nasal Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khaled AL TABAA principal investigator
Hôpital NOVO
Emmanuel PAUTHE principal investigator
CY Paris Université
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septoplasty and Rhinoseptoplasty, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathilde WLODARCZYK (0033130754650, mathilde.wlodarczyk@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Histological Features of Septal, Costal, and Auricular Cartilage (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07717138, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.