Evaluation of the Auryzon Devices in the Optimization of Ear and Nose Reconstruction Procedures

Study Overview
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Brief Summary
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This study evaluates the efficacy of the AuryzoN devices in the ear and nose reconstruction surgeries, both in terms of operative time and overall quality of reconstruction. Research participants will undergo reconstruction either using the AuryzoN device or through current methods (traditional manual processing) at the discretion of their surgeon prior to the start of surgery.

Detailed Description
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The AuryzoN devices are a family of two (2) devices that, in conjunction, serve to process substrates of autologous-derived or cadaveric cartilage used in the reconstruction of various structures of the body, namely ear and nose. The devices are to be used in the operating room to cut and carve substrates of tissue into components, which are then assembled into the final ear or nose, that will then be implanted by the plastic surgeon into the appropriate area. This device family serves to replace the current step in this reconstructive procedure, which involves the time-consuming and error-prone process of manual cartilage processing. Participants will be given the option to participate in the study. If the participants so choose, they will undergo ear or nose reconstruction using the AuryzoN devices or traditional manual processing at the discretion of their surgeon prior to the start of surgery. The following outcome measures will be measured: operative time, error rates, objective quality outcomes of reconstruction, subjective quality outcomes of reconstruction, and patient satisfaction.

Official Title
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Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions

Conditions
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Microtia, Ear Deformities, Acquired, Ear; Deformity, Congenital, Nose Deformity, Nose Deformities, Acquired, Nose; Deformity, Congenital, Nose; Deformity, Congenital, Bent or Squashed, Nose; Deformity, Syphilitic, Congenital, Nose; Deformity, Bone (Nose Cartilage), Nose; Deformity, Septum, Congenital, Nose; Deformity, Sinus (Wall), Congenital, Nose; Deformity, Syphilitic, Late (Etiology), Ear; Deformity, External, Ear; Deformity, Auricle, Ear, Acquired, Ear; Deformity, Auricle, Ear (Congenital)

Intervention / Treatment
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* Device: AuryzoN Family of Devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 1-100 of sufficient health required to undergo ear/nose reconstruction under general anesthesia Pre-existing physical deformity of the ear, nose, or eyelid necessitating surgical reconstruction Sufficient autologous or cadaveric rib cartilage for use by the AuryzoN system for cartilage processing Exclusion Criteria: Patients with ear/nose/eyelid deformities not requiring surgical correction Patients without sufficient rib cartilage for use by the AuryzoN system and those who do not desire cadaveric cartilage use Patients in poor health to undergo surgery under general anesthesia Patients whose desired ear/nose/eyelid exceeds the dimensions/shapes of those pre-fabricated blades used in the AuryzoN system
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auryzon-Processed Ear/Nose<br>Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device. | Device: AuryzoN Family of Devices<br>* The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cartilage processing time | Total operative time spent by the surgeon preparing cartilage substrate into finished structures | Three years (until 2023) | 
| Objective Quality of Reconstruction | An objective scoring system will be developed to score ears and noses based on anatomic accuracy, and reconstructed ears/noses will be scored using this system. Scoring system scale: The following metrics will be assessed by independent observers on a scale from 0-5, with 5 indicating perfect anatomic fidelity as compared to the patient's contralateral ear (or a model ear if no contralateral ear is available) or model nose and 0 indicating complete anatomical difference or loss of that structure. The following ear and nose subcomponents will be graded: Ear: Helix, antihelix, tragus, crus, anatomical proportion of all substrates as compared to each other substrate. Nose: Septum, alar cartilages, lateral cartilages, horizontal strut, anatomical proportion of all substrates as compared to each other substrate. | Up to 1 year post-op (until 2023) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total operative time | Total operative time by the surgeon performing the reconstructive surgery | Three years (until 2023) | 
| Cartilage processing error rate | Number of errors (defined as anatomic deviations) incurred during cartilaginous processing | Three years (until 2023) | 
| Patient satisfaction | Subjective survey completed by patients asking about satisfaction with reconstruction | Up to 1 year post-op (until 2023) | 
| Subjective Quality of Reconstruction | Images of completed ear/nose reconstructions with the AuryzoN system will be presented to surgeons and lay-people to determine overall subjective quality of reconstruction | Up to 1 year post-op (until 2023) |