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

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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