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

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 Overview

• Status: Completed
• Conditions: Mandibular Fractures
• Intervention / Treatment: Device: Control group without use of VSP; Device: Treatment Group with use of VSP

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Device: Control group without use of VSP; 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)
Experimental: Treatment Group	Device: Treatment Group with use of VSP; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from start of ORIF to end of ORIF (about 2-3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Malocclusion		1 week after ORIF
Number of Participants With Malocclusion		3 weeks after ORIF
Number of Participants With Malocclusion		6 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned		1 week after ORIF
Number of Participants With Fractures That Are Not Well Aligned		3 weeks after ORIF
Number of Participants With Fractures That Are Not Well Aligned		6 weeks after ORIF
Number of Participants With Infections		1 week after ORIF
Number of Participants With Infections		3 weeks after ORIF
Number of Participants With Infections		6 weeks after ORIF
Type of Archbars Used in ORIF	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.	from start of ORIF to end of ORIF (about 2-3 hours)
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	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).	from start of ORIF to end of ORIF (about 2-3 hours)
Number of Participants Who Required Intraoperative Surgical Revisions		from start of ORIF to end of ORIF (about 2-3 hours)
Distance of Maximal Interincisal Opening	Maximal interincisal opening is the maximum distance a person can open their mouth between their upper and lower incisors measured in millimeters.	6 weeks after ORIF
Number of Participants With Hardware Failure	Number of Participants with hardware failure as defined as plate fracture or screw loosening	from baseline to 6 weeks after ORIF

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Stryker Instruments
• Investigators: Principal Investigator: Timothy Woernley, DDS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2021
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): November 10, 2022

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Fractures, Bone; Mandibular Fractures
• Other Study ID Numbers: HSC-DB-19-1074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes