Treatment Group with use of VSP for Jaw Fractures

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Jaw FracturesTreatment Group with use of VSP - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is comparing two techniques for operating room time, one with and one without Virtual surgical Planning (VSP).

Eligible Conditions
  • Jaw Fractures

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
EB-CMF
1
ENSEAL X1 Curved Jaw
2
Treatment group

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: End of dissection until final screws are placed,about 2-3 hours

6 weeks post surgery
Number of participants with fractures that are not well aligned
Number of participants with infections
Number of participants with malocclusion
Hour 3
The time taken to complete an open reduction internal fixation (ORIF)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
EB-CMF
1
ENSEAL X1 Curved Jaw
3
Treatment group

Trial Design

2 Treatment Groups

Control Group
1 of 2
Treatment Group
1 of 2

Active Control

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment Group with use of VSP · No Placebo Group · N/A

Treatment Group
Device
Experimental Group · 1 Intervention: Treatment Group with use of VSP · Intervention Types: Device
Control Group
Device
ActiveComparator Group · 1 Intervention: Control group without use of VSP · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: end of dissection until final screws are placed,about 2-3 hours

Who is running the clinical trial?

Stryker InstrumentsIndustry Sponsor
14 Previous Clinical Trials
1,455 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
811 Previous Clinical Trials
256,207 Total Patients Enrolled
1 Trials studying Jaw Fractures
174 Patients Enrolled for Jaw Fractures
Timothy Woernley, DDSPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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References

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