NCT03297736

Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Nitinetics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Middle Ear Disease

Interventions

Type	Name	Description
DEVICE	3D CAD/CAM autograft prosthesis	Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
DEVICE	Control device	Surgical ossicular reconstruction with the standard available middle ear prosthesis.

Timeline

• Start date: 2016-03-01
• Primary completion: 2021-03-31
• Completion: 2023-03-31
• First posted: 2017-09-29
• Last updated: 2020-09-24

Locations

1 site across 1 country: United States