N/A
N=28
Comparison of Operating Room Time Length With the Use of Virtual Surgical Planning Versus Conventional Treatment of Mandible Fractures
Mandibular Fractures
Bottom Line
View on ClinicalTrials.gov: NCT04283981 ↗Enrolled (actual)
28
Serious AEs
7.1%
Results posted
Jun 2024
Primary outcome: Primary: The Time Taken to Complete an Open Reduction Internal Fixation (ORIF) — 54.6; 34 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Control group without use of VSP (Device); Treatment Group with use of VSP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Time Taken to Complete an Open Reduction Internal Fixation (ORIF) |
54.6; 34 | — |
| SECONDARY Number of Participants With Malocclusion |
2; 0 | — |
| SECONDARY Number of Participants With Malocclusion |
2; 0 | — |
| SECONDARY Number of Participants With Malocclusion |
2; 0 | — |
| SECONDARY Number of Participants With Fractures That Are Not Well Aligned |
0; 0 | — |
| SECONDARY Number of Participants With Fractures That Are Not Well Aligned |
0; 0 | — |
| SECONDARY Number of Participants With Fractures That Are Not Well Aligned |
0; 0 | — |
| SECONDARY Number of Participants With Infections |
0; 0 | — |
| SECONDARY Number of Participants With Infections |
0; 0 | — |
| SECONDARY Number of Participants With Infections |
0; 0 | — |
| SECONDARY Type of Archbars Used in ORIF |
2; 0; 10; 9; 2; 0 | — |
| SECONDARY Number of Participants Whose Occlusal Splint Fit Appropriately |
7 | — |
| SECONDARY Type of Surgical Approach to the Fracture Site |
7; 5; 7; 7 | — |
| SECONDARY Number of Participants Who Required Intraoperative Surgical Revisions |
— | — |
| SECONDARY Distance of Maximal Interincisal Opening |
34.6; 31.8 | — |
| SECONDARY Number of Participants With Hardware Failure |
0; 0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04283981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.