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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03297736
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Middle Ear Disease Device: 3D CAD/CAM autograft prosthesis Device: Control device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Disorders

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.




Primary Outcome Measures :
  1. Cost savings [ Time Frame: perioperative ]
    operative costs compared between treatment groups utilizing total operative time in minutes


Secondary Outcome Measures :
  1. 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

  2. ABG [ Time Frame: preoperative; 6weeks, 3 months, and 6 months postoperatively. ]
    mean air-bone gap assessed and compared between treatment groups for statistical significance

  3. Number of participants that experience device rejection [ Time Frame: 6 months ]
    rejection of device/prosthesis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • congenital anomalies

Information from the National Library of Medicine

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


Contacts
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Contact: Glenn Knox, M.D., J.D. (904) 244-3498 Glenn.Knox@jax.ufl.edu
Contact: Alisa Knox alisa102189@yahoo.com

Locations
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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   
Sponsors and Collaborators
Nitinetics LLC
Investigators
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Principal Investigator: Glenn Knox, M.D., J.D. Nitinetics LLC
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Responsible Party: Nitinetics LLC
ClinicalTrials.gov Identifier: NCT03297736    
Other Study ID Numbers: 3D CAD/CAM
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases