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

Nitinetics

Status: Unknown

Conditions: Middle Ear Disease

Treatments: Device: Control device; Device: 3D CAD/CAM autograft prosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03297736

3D CAD/CAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction

Exclusion criteria

• congenital anomalies

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Control

Active Comparator group

Description:

Subjects receive the control device.

Treatment:

Device: Control device

Investigational device

Experimental group

Description:

Subject receives the 3D CAD/CAM autograft prosthesis implant.

Treatment:

Device: 3D CAD/CAM autograft prosthesis