Recruiting

Osteotomy Accuracy

Sponsor:

Augusta University

Code:

NCT05461118

Conditions

Osteotomy

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Experimental:Treatment group

Study Details

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

Study ID

NCT05461118

Start date

Aug 5, 2022

Status verified date

Jul, 2022

Completion date

Sep 1, 2023

Anticipated

Primary completion date

Mar 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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 ®).

Interventions

Experimental:Treatment group

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

Primary outcome measure

  • Measurements of osteotomy change on one-time post-operative imaging of CT scans [ Time Frame: One time measurement completed within 1 month of surgery on postoperative CT scans of the face that are obtained within 3 weeks following surgery. ]

Central Contacts and Locations

Central contacts

Marshall F Newman, DMD

706-723-4511marnewman@augusta.edu

Jaspreet Farmaha, PhD

706-721-1270jfarmaha@augusta.edu

Locations

Augusta University-Dental College of Georgia

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Marshall Newman, DMD

706-723-4511marnewman@augusta.edu

Jaspreet Farmaha, PhD

7067211270jfarmaha@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Aug 1, 2022

Last verified

Jul, 2022

Keywords

  • Mixed Reality Navigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Augusta University on 2022-08-01.