Clinical trial NCT04283981: Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
Official title: Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2020-02-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: The Time Taken to Complete an Open Reduction Internal Fixation (ORIF)
timeFrame: from start of ORIF to end of ORIF (about 2-3 hours)
Secondary outcomes:
measure: Number of Participants With Malocclusion
timeFrame: 1 week after ORIF
measure: Number of Participants With Malocclusion
timeFrame: 3 weeks after ORIF
measure: Number of Participants With Malocclusion
timeFrame: 6 weeks after ORIF
measure: Number of Participants With Fractures That Are Not Well Aligned
timeFrame: 1 week after ORIF
measure: Number of Participants With Fractures That Are Not Well Aligned
timeFrame: 3 weeks after ORIF
measure: Number of Participants With Fractures That Are Not Well Aligned
timeFrame: 6 weeks after ORIF
measure: Number of Participants With Infections
timeFrame: 1 week after ORIF
measure: Number of Participants With Infections
timeFrame: 3 weeks after ORIF
measure: Number of Participants With Infections
timeFrame: 6 weeks after ORIF
measure: Type of Archbars Used in ORIF
timeFrame: from start of ORIF to end of ORIF (about 2-3 hours)
measure: Number of Participants Whose Occlusal Splint Fit Appropriately
timeFrame: from start of ORIF to end of ORIF (about 2-3 hours)
measure: Type of Surgical Approach to the Fracture Site
timeFrame: from start of ORIF to end of ORIF (about 2-3 hours)
measure: Number of Participants Who Required Intraoperative Surgical Revisions
timeFrame: from start of ORIF to end of ORIF (about 2-3 hours)
measure: Distance of Maximal Interincisal Opening
timeFrame: 6 weeks after ORIF
measure: Number of Participants With Hardware Failure
timeFrame: from baseline to 6 weeks after ORIF
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Timothy Woernley, DDS
role: PRINCIPAL_INVESTIGATOR
References: