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

Not Applicable

Completed

Conditions: Mandibular Fractures

Interventions: Device: Treatment Group with use of VSP
Device: Control group without use of VSP

Registration Number: NCT04283981

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Treatment Group with use of VSP	-
Control Group	Control group without use of VSP	-

Primary Outcome Measures

Name	Time	Method
The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)	from start of ORIF to end of ORIF (about 2-3 hours)	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Infections	6 weeks after ORIF
Type of Archbars Used in ORIF	from start of ORIF to end of ORIF (about 2-3 hours)	Archbars are used for fixating jaws during the treatment of mandible fractures. Archbars are anchored onto both jaws (that is, onto the maxillar/upper jaw, and onto the mandibular/lower jaw); therefore, each participant receives 2 arch bars, one for each jaw. Data are reported categorically as the type of arch bar received for a jaw.
Number of Participants Who Required Intraoperative Surgical Revisions	from start of ORIF to end of ORIF (about 2-3 hours)
Number of Participants With Malocclusion	6 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned	6 weeks after ORIF
Number of Participants Whose Occlusal Splint Fit Appropriately	from start of ORIF to end of ORIF (about 2-3 hours)
Type of Surgical Approach to the Fracture Site	from start of ORIF to end of ORIF (about 2-3 hours)	The type of surgical approach to the fracture site is reported categorically as either extraoral or intraoral. This is counted based on each fracture approached surgically (a participant may have more than 1 approach if they had more than 1 fracture site).
Distance of Maximal Interincisal Opening	6 weeks after ORIF	Maximal interincisal opening is the maximum distance a person can open their mouth between their upper and lower incisors measured in millimeters.
Number of Participants With Hardware Failure	from baseline to 6 weeks after ORIF	Number of Participants with hardware failure as defined as plate fracture or screw loosening