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

The University of Texas Health Science Center, Houston28 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mandibular Fractures

Interventions

Control group without use of VSPDEVICE

The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)

Treatment Group with use of VSPDEVICE

The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)

The time taken to complete an Open Reduction Internal Fixation (ORIF) \[referred to as the "plating time"\] was defined as beginning after dissection was complete and fractures were initially reduced, and ending after all fracture sites were fixated with the final screw placed.

Time frame: from start of ORIF to end of ORIF (about 2-3 hours)

Secondary Outcomes

Number of Participants With Malocclusion

Time frame: 1 week after ORIF

Number of Participants With Malocclusion

Time frame: 3 weeks after ORIF

Number of Participants With Malocclusion

Time frame: 6 weeks after ORIF

Number of Participants With Fractures That Are Not Well Aligned

Time frame: 1 week after ORIF

Number of Participants With Fractures That Are Not Well Aligned

Time frame: 3 weeks after ORIF

Number of Participants With Fractures That Are Not Well Aligned

Time frame: 6 weeks after ORIF

Number of Participants With Infections

Time frame: 1 week after ORIF

Number of Participants With Infections

Time frame: 3 weeks after ORIF

Number of Participants With Infections

Time frame: 6 weeks after ORIF

Data from ClinicalTrials.gov

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