Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
NCT ID: NCT03297736
Last Updated: 2020-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-03-01
2023-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Control
Subjects receive the control device.
Control device
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
Investigational device
Subject receives the 3D CAD/CAM autograft prosthesis implant.
3D CAD/CAM autograft prosthesis
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
Interventions
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3D CAD/CAM autograft prosthesis
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
Control device
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Nitinetics LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Glenn Knox, M.D., J.D.
Role: PRINCIPAL_INVESTIGATOR
Nitinetics LLC
Locations
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University of Florida-Jacksonville
Jacksonville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3D CAD/CAM
Identifier Type: -
Identifier Source: org_study_id
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