Multi-Institutional IMPACT Validation

NCT06850857 | Enrolling By Invitation

• 1 other identifier: 24-09945-XP
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Facial Trauma; Maxillofacial Trauma; Patient-Reported Outcomes; Quality of Life; IMPACT; Mandible Fracture; Midface Fracture; Orbital Fracture; Nasal Fracture

Outcome Measures

Primary Outcomes (1)

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

  Criterion validity will primarily be determined by calculating the correlation between each of the IMPACT module total scores and the 15D QOL control survey via Pearson's r, controlling for independent variables that influence survey scores.

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

Secondary Outcomes (4)

• Reliability: Covariance of each item in the IMPACT modules and subscales

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

• Sensitivity to Change: Change in IMPACT scores over the treatment course.

  At the completion of the second survey.

• Sensitivity to Change: Change in IMPACT scores over the treatment course.

  Baseline (at recruitement, Day 0) and at 4 weeks.

• Minimally Clinically Important Difference (MCID)

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

Other Outcomes (1)

• Independent predictors of IMPACT scores

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

Study Arms (3)

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.

Other: IMPACT-G Module; Other: IMPACT-N Module; Other: 15D Control Survey

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.

Other: IMPACT-G Module; Other: IMPACT-O Module; Other: 15D Control Survey

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.

Other: IMPACT-G Module; Other: IMPACT-J Module; Other: 15D Control Survey

Interventions

IMPACT-G Module OTHER

Administration of the general IMPACT survey module.

Jaw Fractures (IMPACT-J); Nasal Fractures (IMPACT-N); Orbital Fractures (IMPACT-O)

IMPACT-N Module OTHER

Administration of the IMPACT-N survey module.

Nasal Fractures (IMPACT-N)

IMPACT-O Module OTHER

Administration of the IMPACT-O survey module.

Orbital Fractures (IMPACT-O)

IMPACT-J Module OTHER

Administration of the IMPACT-J survey module.

Jaw Fractures (IMPACT-J)

15D Control Survey OTHER

Administration of the 15D QOL control survey.

Jaw Fractures (IMPACT-J); Nasal Fractures (IMPACT-N); Orbital Fractures (IMPACT-O)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified from the population of patients presenting to clinics where facial trauma is managed, including otolaryngology, oral and maxillofacial surgery, plastic surgery, and/or ophthalmology clinic(s).

You may qualify if:

• \. Diagnosis of maxillofacial trauma (fracture of any facial bone\[s\] and/or soft tissue injury) within 12 months of recruitment date.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Tennessee: lead
• University of California, San Francisco: collaborator
• University of California, Davis: collaborator
• University of Maryland: collaborator
• Vanderbilt University: collaborator

Study Sites (3)

University of California, Davis

Sacramento, California, 95817, United States

Location

University of California, San Francisco

San Francisco, California, 94110, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38103, United States

Location

Related Publications (2)

• Terwee CB, Prinsen CAC, Chiarotto A, Westerman MJ, Patrick DL, Alonso J, Bouter LM, de Vet HCW, Mokkink LB. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res. 2018 May;27(5):1159-1170. doi: 10.1007/s11136-018-1829-0. Epub 2018 Mar 17.

  PMID: 29550964 BACKGROUND

• Ologunde R, McLeod NMH. Use of patient-reported outcome measures in oral and maxillofacial trauma surgery: a review. Br J Oral Maxillofac Surg. 2018 Jun;56(5):371-379. doi: 10.1016/j.bjoms.2018.03.010. Epub 2018 Apr 9.

  PMID: 29650475 BACKGROUND

MeSH Terms

Conditions

Facial Injuries; Mandibular Fractures; Orbital Fractures; Zygomatic Fractures; Tooth, Impacted

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Jaw Fractures; Maxillofacial Injuries; Skull Fractures; Fractures, Bone; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (3)