Multi-Institutional IMPACT Validation

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.

Conditions

• Facial Injuries
• Mandible Fracture
• Le Fort
• Zygomaticomaxillary Complex Fracture
• Nasal Fracture
• Orbital Fractures
• Zygoma Fracture
• Orbital Floor Fracture
• Facial Laceration

Interventions

OTHER

IMPACT-G Module

Administration of the general IMPACT survey module.

OTHER

IMPACT-N Module

Administration of the IMPACT-N survey module.

OTHER

IMPACT-O Module

Administration of the IMPACT-O survey module.

OTHER

IMPACT-J Module

Administration of the IMPACT-J survey module.

OTHER

15D Control Survey

Administration of the 15D QOL control survey.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• University of Tennessee

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-06-30

Completion

2026-12-31

Countries

• United States

Study Locations