Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
Purpose
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
Condition
- Mandibular Fractures
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Control Group |
|
|
Experimental Treatment Group |
|
Recruiting Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston