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

  • STATUS
    Recruiting
  • End date
    Feb 19, 2022
  • participants needed
    50
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 19 April 2021

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

Details
Condition Fracture of mandible
Treatment Control group without use of VSP, Treatment Group with use of VSP
Clinical Study IdentifierNCT04283981
SponsorThe University of Texas Health Science Center, Houston
Last Modified on19 April 2021

Eligibility

Yes No Not Sure

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)
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