Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
500 participants
OBSERVATIONAL
2025-07-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Objectives: This study will be a multi-institutional field test to determine the validity and reliability of using the IMPACT for measuring QOL in patients suffering maxillofacial trauma. The hypothesis is that each IMPACT module and subscale will significantly and at least moderately correlate with the 15D, an established general QOL survey instrument.
Methods: Patients with maxillofacial trauma presenting for routine follow-up within one year from their injury will be invited to complete the IMPACT and the 15D survey. Patients who completed an initial survey and return within one month will be invited to complete a second follow-up survey. The scores be tested for validity and reliability using multivariable linear regression, Pearson's r, Cronbach alpha, and test-retest reliability. The sensitivity to change and minimally clinically important difference (MCID) will also be calculated.
Impact: Validation of the first PROM for maxillofacial trauma is anticipated to have a significant and lasting impact in the field of maxillofacial trauma. This will allow researchers and clinicians to better understand the patient experience and make management recommendations accordingly. Integrating the IMPACT into future studies may revolutionize the field by providing novel evidence for controversial topics such as maxillomandibular fixation techniques, surgical approaches, adjunctive therapies, and more.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
IMPACT-G Module
Administration of the general IMPACT survey module.
IMPACT-N Module
Administration of the IMPACT-N survey module.
15D Control Survey
Administration of the 15D QOL 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.
IMPACT-G Module
Administration of the general IMPACT survey module.
IMPACT-O Module
Administration of the IMPACT-O survey module.
15D Control Survey
Administration of the 15D QOL 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.
IMPACT-G Module
Administration of the general IMPACT survey module.
IMPACT-J Module
Administration of the IMPACT-J survey module.
15D Control Survey
Administration of the 15D QOL control survey.
Interventions
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IMPACT-G Module
Administration of the general IMPACT survey module.
IMPACT-N Module
Administration of the IMPACT-N survey module.
IMPACT-O Module
Administration of the IMPACT-O survey module.
IMPACT-J Module
Administration of the IMPACT-J survey module.
15D Control Survey
Administration of the 15D QOL control survey.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with isolated fractures of the cranium or teeth.
3. Patients who cannot read, write, and/or speak English.
4. 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)
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
University of California, Davis
OTHER
University of Maryland
OTHER
Vanderbilt University
OTHER
University of Tennessee
OTHER
Responsible Party
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Locations
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University of California, Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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24-09945-XP
Identifier Type: -
Identifier Source: org_study_id
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