Osteotomy Accuracy Using Mixed Reality Assisted Navigation

NCT05461118 | Unknown

• 1 other identifier: [1829157
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

An osteotomy is a standard surgical operation in which one or more bones are cut or lengthened or re-shaped. While planning for osteotomy, the surgeon sometimes uses a custom-manufactured cutting guide. The investigators are testing a relatively new approach called mixed reality navigation in planning this surgery in this study. For the purpose of this study, the investigators will compare the accuracy of performing osteotomies with the aid of mixed reality navigation as compared to osteotomies that were performed using prefabricated cutting guides for patients in the past few years.

Conditions

Osteotomy

Keywords

Mixed Reality Navigation

Outcome Measures

Primary Outcomes (1)

• Measurements of osteotomy change on one-time post-operative imaging of CT scans

  3-dimensional depth mapping of postoperative CT scans overlaid on preoperative virtually planned osteotomy to assess for a change from the preoperative plan measured in millimeters

  One time measurement completed within 1 month of surgery on postoperative CT scans of the face that are obtained within 3 weeks following surgery.

Study Arms (1)

Treatment group

EXPERIMENTAL

Consented subjects will undergo osteotomies for their resective and reconstructive procedures using mixed reality adjuncts (Magic Leap ®, Microsoft Hololens ®) to commercially available navigation platforms (BrainLAB ®).

Procedure: Experimental:Treatment group

Interventions

Experimental:Treatment group PROCEDURE

Osteotomy surgical planning to be done using intraoperative mixed reality augmentation of a commercially available navigation platform.

Treatment group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 16 years and older
• Has a benign or malignant mandibular or maxillary pathology who will require resection and who will undergo immediate reconstruction
• Consents to have resective and reconstructive procedures completed with the aid of mixed reality assisted navigation.

You may not qualify if:

• Presence of acute infection at the time of surgery
• Not able to speak in English or illiterate or lacking the decision-making capacity to consent for study.
• Pregnant women because elective surgery is usually delayed until after delivery to avoid risks and complications associated with anesthetics

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University-Dental College of Georgia

Augusta, Georgia, 30912, United States

RECRUITING

Study Officials

• Marshall F Newman, DMD

  Dental College of Georgia- Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marshall F Newman, DMD

CONTACT

706-723-4511; marnewman@augusta.edu

Jaspreet Farmaha, PhD

CONTACT

706-721-1270; jfarmaha@augusta.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is an interventional clinical trial, in which prospectively enrolled subjects will be compared with the historical control arm.

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 15, 2022
• Study Start: August 5, 2022
• Primary Completion: March 15, 2023
• Study Completion: September 1, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)