Status:
COMPLETED
Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Stryker Instruments
Conditions:
Mandibular Fractures
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Patient consent
- Complex mandible fracture (at least two fractures) that require ORIF of at least one fracture. This will exclude condylar fractures
Exclusion
- 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)
Key Trial Info
Start Date :
January 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04283981
Start Date
January 24 2021
End Date
November 10 2022
Last Update
June 20 2024
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030