An interventional study of 3D CAD/CAM autograft prosthesis and Control device in Middle Ear Disease, sponsored by Nitinetics LLC. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by Nitinetics LLC · Not applicable, Interventional, and Device feasibility
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.
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.
Exclusion Criteria:
Subjects receive the control device.
Device: Control 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.
Surgical ossicular reconstruction with the standard available middle ear prosthesis.
Cost savings
operative costs compared between treatment groups utilizing total operative time in minutes
Time frame: perioperative
Number of participants with treatment related adverse events as assessed by CTCAE v4.0
infectious process involving the use of a medical device
Time frame: 6 months
ABG
mean air-bone gap assessed and compared between treatment groups for statistical significance
Time frame: preoperative; 6weeks, 3 months, and 6 months postoperatively.
Number of participants that experience device rejection
rejection of device/prosthesis
Time frame: 6 months
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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