Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/18/2019 |
| Start Date: | March 1, 2016 |
| End Date: | March 31, 2020 |
| Contact: | Glenn Knox, M.D., J.D. |
| Email: | Glenn.Knox@jax.ufl.edu |
| Phone: | (904) 244-3498 |
Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment.
Study participants, requiring middle ear surgery and ossicular reconstruction, will be
implanted with one of two middle ear implants. The rationale is to complete a pilot study of
the technology with a small number of designs. Each implant will be commonly used, in the
public domain, and recreated by the CAD/CAM software.
Study participants, requiring middle ear surgery and ossicular reconstruction, will be
implanted with one of two middle ear implants. The rationale is to complete a pilot study of
the technology with a small number of designs. Each implant will be commonly used, in the
public domain, and recreated by the CAD/CAM software.
Conventional middle ear prosthetic prosthetics, including total ossicular replacement
prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive,
require large inventories for otologic surgery services, and carry the risk of extrusion or
rejection. Autologous bone and cartilage can be used for many of these applications, but it
requires expensive operating room time for carving to the appropriate shape and size.
The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted
design/computer assisted manufacture) to produce accurate bone and cartilage autografts on
demand in the operating room. Such a technology is hypothesized to save money by reducing
operating room time, and reducing the need for expensive inventories of various shapes,
sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be
less likely to extrude or cause other problems such as infection, this could also reduce
costs.
prostheses (TORPs) and partial ossicular replacement prostheses (PORPs) are expensive,
require large inventories for otologic surgery services, and carry the risk of extrusion or
rejection. Autologous bone and cartilage can be used for many of these applications, but it
requires expensive operating room time for carving to the appropriate shape and size.
The above considerations led to the concept of subtractive 3D CAD/CAM (computer assisted
design/computer assisted manufacture) to produce accurate bone and cartilage autografts on
demand in the operating room. Such a technology is hypothesized to save money by reducing
operating room time, and reducing the need for expensive inventories of various shapes,
sizes, and types of prosthetic devices. Since autologous materials are hypothesized to be
less likely to extrude or cause other problems such as infection, this could also reduce
costs.
Inclusion Criteria:
- at least 18 years of age with middle ear disease requiring surgical ossicular
reconstruction
Exclusion Criteria:
- congenital anomalies
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