Multi-Institutional IMPACT Validation

Part of paid clinical trials in Sacramento, California.

Sponsor
University of Tennessee
Study ID
NCT06850857
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMPACT-G Module — OTHER
    Administration of the general IMPACT survey module.
  • IMPACT-N Module — OTHER
    Administration of the IMPACT-N survey module.
  • IMPACT-O Module — OTHER
    Administration of the IMPACT-O survey module.
  • IMPACT-J Module — OTHER
    Administration of the IMPACT-J survey module.
  • 15D Control Survey — OTHER
    Administration of the 15D QOL control survey.

Study Details

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 Dates

First listed
Feb 27, 2025
Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Nasal Fractures (IMPACT-N)
    This group includes patients with fracture patterns that involve the nasal bones, nasal cavity, and/or sinuses, including: isolated nasal bone fractures, nasoorbitoethmoidal fractures, maxillary sinus fractures, Le Fort I-III fractures, and frontal sinus fractures.
  • Arm: Orbital Fractures (IMPACT-O)
    This group includes patients with fracture patterns that involve the orbital walls or rim, including: isolated orbital fractures, zygomaticomaxillary complex fractures, nasoorbitoethmoidal fractures, and Le Fort II-III fractures.
  • Arm: Jaw Fractures (IMPACT-J)
    This group includes patients with fracture patterns that involve the upper or lower jaw, including: mandible fractures, dentoalveolar fractures, and Le Fort I-III fractures. Zygomatic arch fractures will also be included given potential impairment of the jaw.

Primary Outcome Measure

Criterion validity: Correlation of IMPACT modules with the 15D QOL control survey [ Time Frame: When the initial survey is completed (within 12 months of the injury). ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95817-
University of California, San FranciscoSan FranciscoCalifornia94110-
University of Tennessee Health Science CenterMemphisTennessee38103-

Find similar trials in Sacramento, CA

By research site
University of California, Davis· Sacramento, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Tennessee Health Science Center· Memphis, TN

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