Evaluation of the Auryzon Family of Cartilage Processing Devices in the Optimization of Cartilaginous Reconstructions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Total cartilage processing time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Auryzon-Processed Ear/Nose
Patients in this category underwent reconstruction and implantation of a completed ear/nose cartilaginous graft that was processed using the AuryzoN device.
干预措施: AuryzoN Family of Devices (Device)
结局指标
主要结局
Total cartilage processing time
时间窗: Three years (until 2023)
Total operative time spent by the surgeon preparing cartilage substrate into finished structures
Objective Quality of Reconstruction
时间窗: Up to 1 year post-op (until 2023)
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.
次要结局
- Patient satisfaction(Up to 1 year post-op (until 2023))
- Cartilage processing error rate(Three years (until 2023))
- Subjective Quality of Reconstruction(Up to 1 year post-op (until 2023))
- Total operative time(Three years (until 2023))