Osteotomy Accuracy Using Mixed Reality Assisted Navigation

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.

Study Overview

• Status: Recruiting
• Conditions: Osteotomy
• Intervention / Treatment: Procedure: Experimental:Treatment group

Detailed Description

The use of virtual surgical planning and custom cutting guide fabrication for craniomaxillofacial osteotomies is becoming more and more common, but it remains very expensive at present, particularly for cranial procedures. As such, many practitioners utilize open-source third-party software and in-house 3D printing to aid in reducing operating costs while maintaining surgical precision and accuracy as well as the benefits of decreased intraoperative time. The use of augmented and mixed reality platforms in craniomaxillofacial surgery has demonstrated usefulness in both preoperative planning and intraoperative visualization. It has been used in the past several years during craniofacial resective procedures, orthognathic surgery, dental implantology, and surgical education.

The purpose of investigating the accuracy of preplanned craniomaxillofacial osteotomies using the aid of a mixed reality platform viewer to augment currently available navigation platforms is to demonstrate a non-inferiority of the osteotomy technique compared to the current clinical gold standard for both precision and accuracy of craniomaxillofacial osteotomies - the use of custom patient-specific cutting guides based on preoperative virtual surgical planning.

The primary objective of this prospective study is to evaluate the accuracy of craniomaxillofacial osteotomies performed with the aid of mixed reality navigation as compared to osteotomies performed using prefabricated cutting guides for similar procedures that have been planned virtually preoperatively.

The secondary objective is to determine if osteotomies performed using mixed reality navigation can be effectively completed in a minimally invasive manner.

Hypothesis: Craniomaxillofacial osteotomies performed via the mixed reality navigation method can be completed with the same degree of accuracy to a preoperative virtual surgical plan as with the use of custom printed cutting guides or within 2 mm of variance.

Sample size: n=16 patients/group to achieve a power of 0.8 and a significance level of 0.05. The investigators expect to recruit 40 patients total for the study site, including a 20% drop rate for each group

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaspreet Farmaha, PhD; Phone Number: 706-721-1270; Email: jfarmaha@augusta.edu
• Study Contact Backup: Name: Marshall F Newman, DMD; Phone Number: 706-723-4511; Email: marnewman@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University-Dental College of Georgia
      • Contact: Jaspreet Farmaha, PhD; Phone Number: 7067211270; Email: jfarmaha@augusta.edu
      • Contact: Marshall Newman, DMD; Phone Number: 706-723-4511; Email: marnewman@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; 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; Osteotomy surgical planning to be done using intraoperative mixed reality augmentation of a commercially available navigation platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Marshall F Newman, DMD, Dental College of Georgia- Augusta University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 5, 2022
• Primary Completion (Anticipated): March 15, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Mixed Reality Navigation
• Other Study ID Numbers: [1829157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study results will be published in a peer-reviewed journal upon completion and presented at appropriate conferences.

Drug and device information, study documents

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