Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Nitinetics LLC
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Cost savings
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction
Exclusion Criteria
- •congenital anomalies
Arms & Interventions
Control
Subjects receive the control device.
Intervention: Control device (Device)
Investigational device
Subject receives the 3D CAD/CAM autograft prosthesis implant.
Intervention: 3D CAD/CAM autograft prosthesis (Device)
Outcomes
Primary Outcomes
Cost savings
Time Frame: perioperative
operative costs compared between treatment groups utilizing total operative time in minutes
Secondary Outcomes
- ABG(preoperative; 6weeks, 3 months, and 6 months postoperatively.)
- Number of participants that experience device rejection(6 months)
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0(6 months)