Multi-Institutional IMPACT Validation
Enrolling by invitation
Conditions studied: Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture, Nasal Fracture, Orbital Fractures, Zygoma Fracture, Orbital Floor Fracture, Facial Laceration
In brief
The goal of this observational study is to validate a novel patient-reported outcome measure (PROM) for patients suffering maxillofacial trauma: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The primary question is: Are the IMPACT modules valid and reliable measures to study quality-of-life (QOL) in patients with maxillofacial trauma? Patients presenting for routine clinic follow-up for maxillofacial trauma will be invited to complete the IMPACT in addition to the 15 Dimension (15D) QOL survey as a control.
Key facts
- Study ID
- NCT06850857
- Run by
- University of Tennessee
- People needed
- 500
- Starts
- 2025-07-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of maxillofacial trauma (fracture of any facial bone[s] and/or soft tissue injury) within 12 months of recruitment date.
You may not qualify if…
- Patients presenting to clinic for reasons not related to maxillofacial trauma.
- Patients with isolated fractures of the cranium or teeth.
- Patients who cannot read, write, and/or speak English.
- Patients who are unable to provide informed consent for themselves (including those who are under 18 years old, incapacitated, intoxicated, or cognitively impaired with a legal guardian)
Where it is running
- University of California, Davis — Sacramento, California, United States
- University of California, San Francisco — San Francisco, California, United States
- University of Tennessee Health Science Center — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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