Osteotomy Accuracy Using Mixed Reality Assisted Navigation

NCT ID: NCT05461118

Last Updated: 2022-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-09-01

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.

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

Conditions

Osteotomy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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 ®).

Group Type: EXPERIMENTAL

Experimental:Treatment group

Intervention Type: PROCEDURE

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

Interventions

Experimental:Treatment group

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Marshall Newman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marshall F Newman, DMD

Role: PRINCIPAL_INVESTIGATOR

Dental College of Georgia- Augusta University

Locations

Augusta University-Dental College of Georgia

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marshall F Newman, DMD

Role: CONTACT

marnewman@augusta.edu

706-723-4511

Jaspreet Farmaha, PhD

Role: CONTACT

jfarmaha@augusta.edu

706-721-1270

Facility Contacts

Marshall Newman, DMD

Role: primary

marnewman@augusta.edu

706-723-4511

Jaspreet Farmaha, PhD

Role: backup

jfarmaha@augusta.edu

7067211270

Other Identifiers

[1829157

Identifier Type: -

Identifier Source: org_study_id