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

Not Applicable

• Conditions: Middle Ear Disease
• Interventions: Device: Control device; Device: 3D CAD/CAM autograft prosthesis

• Registration Number: NCT03297736
• Lead Sponsor: Nitinetics LLC

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 Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-09-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-24
• Primary Completion: 2021-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• at least 18 years of age with middle ear disease requiring surgical ossicular reconstruction

Exclusion Criteria

• congenital anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control device	Subjects receive the control device.
Investigational device	3D CAD/CAM autograft prosthesis	Subject receives the 3D CAD/CAM autograft prosthesis implant.

Primary Outcome Measures

Name	Time	Method
Cost savings	perioperative	operative costs compared between treatment groups utilizing total operative time in minutes

Secondary Outcome Measures

Name	Time	Method
ABG	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	6 months	rejection of device/prosthesis
Number of participants with treatment related adverse events as assessed by CTCAE v4.0	6 months	infectious process involving the use of a medical device

Trial Locations

Locations (1)

University of Florida-Jacksonville; 🇺🇸 Jacksonville, Florida, United States