Clinical Trial

Multi-Institutional IMPACT Validation

Enrolling by Invitation
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Record status
This record was last updated June 18, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-24.
Trial Details
NCT Number NCT06850857
Lead Sponsor University of Tennessee
Collaborators: University of California, San Francisco, University of California, Davis, University of Maryland, Vanderbilt University
Conditions Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture, Nasal Fracture, Orbital Fractures, Zygoma Fracture, Orbital Floor Fracture +1 more
Enrollment 500 participants
Start Date 2025-07-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-18