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

Middle Ear Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297736
• Other study ID #: 3D CAD/CAM
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2020
• Source: Nitinetics LLC
• Contact: Glenn Knox, M.D., J.D.
• Phone: (904) 244-3498
• Email: Glenn.Knox[@]jax.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• congenital anomalies

Related Conditions & MeSH terms

• Ear Diseases
• Middle Ear Disease

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Florida-Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nitinetics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost savings	operative costs compared between treatment groups utilizing total operative time in minutes	perioperative
Secondary	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
Secondary	ABG	mean air-bone gap assessed and compared between treatment groups for statistical significance	preoperative; 6weeks, 3 months, and 6 months postoperatively.
Secondary	Number of participants that experience device rejection	rejection of device/prosthesis	6 months