Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts
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|ClinicalTrials.gov Identifier: NCT03297736|
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Middle Ear Disease||Device: 3D CAD/CAM autograft prosthesis Device: Control device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Device Feasibility|
|Official Title:||Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts|
|Actual Study Start Date :||March 1, 2016|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2023|
Active Comparator: Control
Subjects receive the control device.
Device: Control device
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
Experimental: Investigational device
Subject receives the 3D CAD/CAM autograft prosthesis implant.
Device: 3D CAD/CAM autograft prosthesis
Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
- Cost savings [ Time Frame: perioperative ]operative costs compared between treatment groups utilizing total operative time in minutes
- Number of participants with treatment related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]infectious process involving the use of a medical device
- ABG [ Time Frame: 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 [ Time Frame: 6 months ]rejection of device/prosthesis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297736
|Contact: Glenn Knox, M.D., J.D.||(904) 244-3498||Glenn.Knox@jax.ufl.edu|
|Contact: Alisa Knoxfirstname.lastname@example.org|
|United States, Florida|
|University of Florida-Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32209|
|Contact: Glenn Knox, M.D., J.D. 904-244-3498 Glenn.Knox@jax.ufl.edu|
|Principal Investigator:||Glenn Knox, M.D., J.D.||Nitinetics LLC|