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

Mandibular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04283981
• Other study ID #: HSC-DB-19-1074
• Status: Completed
• Phase: N/A
• Start date: January 24, 2021
• Est. completion date: November 10, 2022

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 10, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Mandibular Fractures

Intervention

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)
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Stryker Instruments

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Malocclusion		1 week after ORIF
Secondary	Number of Participants With Malocclusion		3 weeks after ORIF
Secondary	Number of Participants With Malocclusion		6 weeks after ORIF
Secondary	Number of Participants With Fractures That Are Not Well Aligned		1 week after ORIF
Secondary	Number of Participants With Fractures That Are Not Well Aligned		3 weeks after ORIF
Secondary	Number of Participants With Fractures That Are Not Well Aligned		6 weeks after ORIF
Secondary	Number of Participants With Infections		1 week after ORIF
Secondary	Number of Participants With Infections		3 weeks after ORIF
Secondary	Number of Participants With Infections		6 weeks after ORIF
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.	from start of ORIF to end of ORIF (about 2-3 hours)
Secondary	Number of Participants Whose Occlusal Splint Fit Appropriately		from start of ORIF to end of ORIF (about 2-3 hours)
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).	from start of ORIF to end of ORIF (about 2-3 hours)
Secondary	Number of Participants Who Required Intraoperative Surgical Revisions		from start of ORIF to end of ORIF (about 2-3 hours)
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.	6 weeks after ORIF
Secondary	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