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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Middle Ear Disease

Intervention / Treatment
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* Device: 3D CAD/CAM autograft prosthesis
* Device: Control device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction Exclusion Criteria: congenital anomalies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Subjects receive the control device. | Device: Control device<br>* Surgical ossicular reconstruction with the standard available middle ear prosthesis.<br>|
| Experimental: Investigational device<br>Subject receives the 3D CAD/CAM autograft prosthesis implant. | Device: 3D CAD/CAM autograft prosthesis<br>* Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost savings | operative costs compared between treatment groups utilizing total operative time in minutes | perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0 | infectious process involving the use of a medical device | 6 months | 
| ABG | mean air-bone gap assessed and compared between treatment groups for statistical significance | preoperative; 6weeks, 3 months, and 6 months postoperatively. | 
| Number of participants that experience device rejection | rejection of device/prosthesis | 6 months |