Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures

The University of Texas System (UT)

Status

Completed

Conditions

Mandibular Fractures

Treatments

Device: Treatment Group with use of VSP

Device: Control group without use of VSP

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04283981

HSC-DB-19-1074

Details and patient eligibility

About

The purpose of this trial is to compare operating room time between conventional treatment techniques [without Virtual surgical Planning (VSP)] versus treatment with use of Virtual surgical Planning (VSP) in patients that undergo mandibular reconstruction via open reduction internal fixation (ORIF).

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient consent
Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures

Exclusion criteria

Patient refusal to participate in study
Infected mandible fracture
Closed reduction treatment of mandible fracture
Fractures older than 2-3 weeks at the time of treatment
Other concomitant mid-facial bone fractures (ie, zygomaticomaxillary complex (ZMC), Lefort fractures)
Other etiologies than trauma of the mandibular fracture or pathologic fracture secondary to benign or malignant pathology that may require resection
Pregnant patients will NOT be excluded from the study
Co-morbidities (auto-immune disease, osteoporosis, titanium or metal allergy, uncontrolled diabetes (A1c greater than 8)