Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05461118
Study type Interventional
Source Augusta University
Contact Marshall F Newman, DMD
Phone 706-723-4511
Email marnewman@augusta.edu
Status Recruiting
Phase N/A
Start date August 5, 2022
Completion date September 1, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03664791 - Vanguard Rocc Post Market Surveillance
Terminated NCT00209560 - A Study of AQUAVAN® Injection in the Presence of Pre-Medication in Patients Undergoing Minor Surgical Procedures Phase 3
Not yet recruiting NCT04556799 - The Clinical Results of Derotational Osteotomy Based on 3D Osteotomy Template for Treatment of Recurrent Patellar Dislocation Combined With Patellofemoral Maltracking N/A
Completed NCT03487497 - Gait Analysis During Level and Uphill Walking After Lengthening Osteotomy of the Lateral Column
Completed NCT03388736 - Anxiolytic Effect of Lavender Oil on Orthognathic Surgery Patients N/A
Recruiting NCT04894578 - A Comparative Trial of a Minimal-invasive Technique Versus Open Arthrodesis in the Treatment of Midfoot Arthritis N/A
Not yet recruiting NCT06338982 - Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars N/A
Active, not recruiting NCT04653051 - PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
Not yet recruiting NCT06250530 - Comparison Between TOMOFIX and BodyCAD Fine Osteotomy N/A
Completed NCT04000672 - Patient Specific Instrumentation (PSI) Referencing Osteotomy Technological Transfer - a Randomized Control Trial (RCT) N/A
Recruiting NCT05362864 - ZNN Bactiguard Cephalomedullary Nails PMCF Study
Recruiting NCT05339360 - ZNN Bactiguard Antegrade Femoral Nails PMCF Study
Completed NCT04425369 - Iliac Crest Bone Graft Harvesting for Pediatric Pelvic Osteotomy N/A
Enrolling by invitation NCT04376801 - A Retrospective Study on the Outcome of Different Fixation Methods After Olecranon Osteotomy
Completed NCT04109469 - Shark Screw® - Hand- and Foot Surgery Study