Middle Ear Disease
Conditions
Brief 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.
Interventions
DEVICE3D CAD/CAM autograft prosthesis
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
DEVICEControl device
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
Sponsors
Nitinetics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction
Exclusion criteria
* congenital anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost savings | perioperative | operative costs compared between treatment groups utilizing total operative time in minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0 | 6 months | infectious process involving the use of a medical device |
| ABG | preoperative; 6weeks, 3 months, and 6 months postoperatively. | mean air-bone gap assessed and compared between treatment groups for statistical significance |
| Number of participants that experience device rejection | 6 months | rejection of device/prosthesis |
Countries
United States
Contacts
Primary ContactGlenn Knox, M.D., J.D.
Backup ContactAlisa Knox
Outcome results
None listed