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: Recruiting

Administrative data

• NCT number: NCT04283981
• Other study ID #: HSC-DB-19-1074
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2021
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Timothy Woernley, DDS
• Phone: (713) 486-4310
• Email: Timothy.C.Woernley[@]uth.tmc.edu
• 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 use of VSP and surgically-guided techniques and to compare and contrast the effect of any other variables that might have an effect on the overall result

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• 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)		End of dissection until final screws are placed,about 2-3 hours
Secondary	Number of participants with malocclusion		1 week post surgery
Secondary	Number of participants with malocclusion		3 weeks post surgery
Secondary	Number of participants with malocclusion		6 weeks post surgery
Secondary	Number of participants with fractures that are not well aligned		1 week post surgery
Secondary	Number of participants with fractures that are not well aligned		3 weeks post surgery
Secondary	Number of participants with fractures that are not well aligned		6 weeks post surgery
Secondary	Number of participants with infections		1 week post surgery
Secondary	Number of participants with infections		3 weeks post surgery
Secondary	Number of participants with infections		6 weeks post surgery