Comparison of Operating Room Time Length With the Use of... | NCT04283981

NCT04283981

Status Module

Sponsor/Collaborators Module

Name	Class
Stryker Instruments	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Control Group	Active Comparator		Device: Control group without use of VSP
Treatment Group	Experimental		Device: Treatment Group with use of VSP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control group without use of VSP	Device	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)

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Timothy Woernley, DDS	The University of Texas Health Science Center, Houston	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	77030	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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)
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 10, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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)
BG001	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0009 BG0017 BG00216

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00054.6± 28.9 OG00134± 12.5

Secondary

Number of Participants With Malocclusion

Posted

Count of Participants

Participants

1 week after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Malocclusion

Posted

Count of Participants

Participants

3 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Malocclusion

Posted

Count of Participants

Participants

6 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Fractures That Are Not Well Aligned

Posted

Count of Participants

Participants

1 week after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Fractures That Are Not Well Aligned

Posted

Count of Participants

Participants

3 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Fractures That Are Not Well Aligned

Posted

Count of Participants

Participants

6 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Infections

Posted

Count of Participants

Participants

1 week after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Infections

Posted

Count of Participants

Participants

3 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

Number of Participants With Infections

Posted

Count of Participants

Participants

6 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

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.

Posted

Number

archbars

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

jaws

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants

Secondary

Number of Participants Whose Occlusal Splint Fit Appropriately

Data were not collected for 9 participants in the control group

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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)

Units	Counts
Participants	OG000

Secondary

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).

Posted

Number

specified approaches

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

fracture sites

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants

Secondary

Number of Participants Who Required Intraoperative Surgical Revisions

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Secondary

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.

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

Posted

Mean

Standard Deviation

millimeters

6 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants

Secondary

Number of Participants With Hardware Failure

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

Posted

Count of Participants

Participants

from baseline to 6 weeks after ORIF

ID	Title	Description
OG000	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)
OG001	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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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)	0	15	1	15	2	15
EG001	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	0	13	1	13	0	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Postoperative Infection	Infections and infestations	SNOMED CT	Systematic Assessment		EG0001 affected15 at risk EG0011 affected13 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Post-operative Malocclusion of Teeth	Surgical and medical procedures	SNOMED CT	Systematic Assessment		EG0002 affected15 at risk EG0010 affected13 at risk

ID	Term
D008337	Mandibular Fractures

Ancestor Terms

ID	Term
D007572	Jaw Fractures
D008446	Maxillofacial Injuries
D005151	Facial Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases
D012887	Skull Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries

ID	Term
D035061	Control Groups

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods