Trial Outcomes & Findings for Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures (NCT NCT04283981)

NCT ID: NCT04283981

Last Updated: 2024-06-20

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: from start of ORIF to end of ORIF (about 2-3 hours)
• Results posted on: 2024-06-20

Participant Flow

Participant milestones

Measure	Control Group 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)	Treatment Group 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
Overall Study STARTED	15	13
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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	Total n=16 Participants Total of all reporting groups
Age, Continuous	33.9 years STANDARD_DEVIATION 12.3 • n=9 Participants	26.7 years STANDARD_DEVIATION 8.5 • n=7 Participants	30.75 years STANDARD_DEVIATION 10.83 • n=16 Participants
Sex: Female, Male Female	3 Participants n=9 Participants	0 Participants n=7 Participants	3 Participants n=16 Participants
Sex: Female, Male Male	6 Participants n=9 Participants	7 Participants n=7 Participants	13 Participants n=16 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	7 participants n=7 Participants	16 participants n=16 Participants
Mandible Fracture Severity as Assessed by the Mandible Injury Severity Score	15.7 score on a scale STANDARD_DEVIATION 9.4 • n=9 Participants	18.3 score on a scale STANDARD_DEVIATION 8 • n=7 Participants	16.8 score on a scale STANDARD_DEVIATION 8.8 • n=16 Participants
Number of Mandible Fractures	2.33 fractures STANDARD_DEVIATION .50 • n=9 Participants	2.13 fractures STANDARD_DEVIATION .38 • n=7 Participants	2.24 fractures STANDARD_DEVIATION .45 • n=16 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)	54.6 minutes Standard Deviation 28.9	34 minutes Standard Deviation 12.5

SECONDARY outcome

Timeframe: 1 week after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Malocclusion	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 weeks after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Malocclusion	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Malocclusion	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 week after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Fractures That Are Not Well Aligned	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 weeks after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Fractures That Are Not Well Aligned	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Fractures That Are Not Well Aligned	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 week after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Infections	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 weeks after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 weeks after ORIF

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=18 jaws 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)	Treatment Group n=14 jaws 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
Type of Archbars Used in ORIF None	2 archbars	0 archbars
Type of Archbars Used in ORIF Erich	10 archbars	9 archbars
Type of Archbars Used in ORIF Biomet Omnimax	2 archbars	0 archbars
Type of Archbars Used in ORIF Stryker SMARTLock Hybrid	0 archbars	2 archbars
Type of Archbars Used in ORIF Synthes MatrixWAVE	4 archbars	1 archbars
Type of Archbars Used in ORIF Ivy Loops	0 archbars	2 archbars

SECONDARY outcome

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

Population: Data were not collected for 9 participants in the control group

Outcome measures

Measure	Control Group n=7 Participants 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)	Treatment Group 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
Number of Participants Whose Occlusal Splint Fit Appropriately	7 Participants	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Control Group n=14 fracture sites 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)	Treatment Group n=12 fracture sites 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
Type of Surgical Approach to the Fracture Site Extraoral	7 specified approaches	7 specified approaches
Type of Surgical Approach to the Fracture Site Intraoral	7 specified approaches	5 specified approaches

SECONDARY outcome

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

Population: Data were not collected for 9 participants in the control group.

Outcome measures

Measure	Control Group 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)	Treatment Group n=7 Participants 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
Number of Participants Who Required Intraoperative Surgical Revisions	—	0 Participants

SECONDARY outcome

Timeframe: 6 weeks after ORIF

Population: Data were not collected for 4 participants in the control group. Data were not collected for 3 participants in the treatment group.

Maximal interincisal opening is the maximum distance a person can open their mouth between their upper and lower incisors measured in millimeters.

Outcome measures

Measure	Control Group n=5 Participants 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)	Treatment Group n=4 Participants 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
Distance of Maximal Interincisal Opening	34.6 millimeters Standard Deviation 8.16	31.8 millimeters Standard Deviation 6.83

SECONDARY outcome

Timeframe: from baseline to 6 weeks after ORIF

Number of Participants with hardware failure as defined as plate fracture or screw loosening

Outcome measures

Measure	Control Group n=9 Participants 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)	Treatment Group n=7 Participants 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
Number of Participants With Hardware Failure	0 Participants	0 Participants

Adverse Events

Control Group

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Treatment Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Group n=15 participants at risk 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)	Treatment Group n=13 participants at risk 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
Infections and infestations Postoperative Infection	6.7% 1/15 • Up to 6 weeks post-surgery	7.7% 1/13 • Up to 6 weeks post-surgery

Other adverse events

Measure	Control Group n=15 participants at risk 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)	Treatment Group n=13 participants at risk 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
Surgical and medical procedures Post-operative Malocclusion of Teeth	13.3% 2/15 • Up to 6 weeks post-surgery	0.00% 0/13 • Up to 6 weeks post-surgery

Additional Information

Simon Young

The University of Texas Health Science Center at Houston

Phone: (713) 486-2568

Email: simon.young@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place