By InvitationNot Applicable

Multi-Institutional IMPACT Validation

United States500 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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)

What they're measuring

Criterion validity: Correlation of IMPACT modules with the 15D QOL control survey

Timeframe: When the initial survey is completed (within 12 months of the injury).

Trial details

NCT IDNCT06850857

SponsorUniversity of Tennessee

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Facial Injuries trials