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

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.

Study Overview

• Status: Recruiting
• Conditions: Middle Ear Disease
• Intervention / Treatment: Device: Control device; Device: 3D CAD/CAM autograft prosthesis

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Glenn Knox, M.D., J.D.; Phone Number: (904) 244-3498; Email: Glenn.Knox@jax.ufl.edu
• Study Contact Backup: Name: Alisa Knox; Email: alisa102189@yahoo.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Recruiting
      • University of Florida-Jacksonville
      • Contact: Glenn Knox, M.D., J.D.; Phone Number: 904-244-3498; Email: Glenn.Knox@jax.ufl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• congenital anomalies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost savings	operative costs compared between treatment groups utilizing total operative time in minutes	perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
ABG	mean air-bone gap assessed and compared between treatment groups for statistical significance	preoperative; 6weeks, 3 months, and 6 months postoperatively.
Number of participants that experience device rejection	rejection of device/prosthesis	6 months

Collaborators and Investigators

• Sponsor: Nitinetics LLC
• Investigators: Principal Investigator: Glenn Knox, M.D., J.D., Nitinetics LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases
• Other Study ID Numbers: 3D CAD/CAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No