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Multi-Institutional IMPACT Validation

StatusEnrolling by Invitation
PhaseNot specified
Started
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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.

Record History

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  1. Start date: Mar 1, 2025 to Jul 1, 2025v2 Show 6 more changesShow less
    • Primary endpoint revised
    • Interventions: 15D Control Survey (Other), J-SMASH Module (Other), N-SMASH Module (Other), O-SMASH Module (Other), SMASH Module (Other) to 15D Control Survey (Other), IMPACT-G Module (Other), IMPACT-J Module (Other), IMPACT-N Module (Other), IMPACT-O Module (Other)
    • Secondary endpoints: 3 to 4
    • Collaborators: 2 to 4
    • Study title revised
    • Study description expanded, about 4 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture, Nasal Fracture, Orbital Fractures, Zygoma Fracture, Orbital Floor Fracture +1 more
Related terms Facial Injuries, Mandibular Fractures, Orbital Fractures, Tooth, Impacted, Zygomatic Fractures
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov