An observational study in Facial Injuries, Mandible Fracture and Le Fort, sponsored by University of Tennessee. Enrolling by invitation at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by University of Tennessee · Observational
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.
Background: Maxillofacial trauma literature is dominated by objective and physician-rated outcomes, leaving a paucity of patient-reported outcome (PRO) research. In fact, no PRO measure (PROM) has ever been validated in this population, posing a tremendous barrier to our understanding of the patient experience. This project will overcome this barrier by validating a novel PROM designed by our research group: The Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT). The IMPACT is the first PROM designed for maxillofacial trauma, providing novel insight into the patient experience. In its current form, it is a 4-module survey instrument: one general module for all patients (IMPACT-G) and 3 modules specific to fractures of the nasal (IMPACT-N), orbital (IMPACT-O), and/or jaw (IMPACT-J) regions. Each module takes 2-5 minutes to complete for a total of 2-20 minutes, depending on the injury.
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.
29 studies on the registry are indexed under Orbital Fractures; 6 are open to participants now.
Browse Orbital Fractures studies →University of Tennessee is the lead sponsor of 142 studies on the registry; 21 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Compared within Orbital Fractures, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Facial Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Administration of the general IMPACT survey module.
Administration of the IMPACT-N survey module.
Administration of the IMPACT-O survey module.
Administration of the IMPACT-J survey module.
Administration of the 15D QOL control survey.
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.
Time frame: When the initial survey is completed (within 12 months of the injury).
Reliability: Covariance of each item in the IMPACT modules and subscales
The reliability of each module and subscale will be measured via Cronbach alpha's measurement of internal consistency,
Time frame: When the initial survey is completed (within 12 months of the injury).
Sensitivity to Change: Change in IMPACT scores over the treatment course.
The sensitivity to change will be evaluated by comparing consecutive IMPACT module and subscale scores for patients who completed the survey two times.
Time frame: At the completion of the second survey.
Sensitivity to Change: Change in IMPACT scores over the treatment course.
Follow-up IMPACT scores will be collected 4 weeks from the baseline recruitment and analyzed for improvement from the baseline scores.
Time frame: Baseline (at recruitement, Day 0) and at 4 weeks.
Minimally Clinically Important Difference (MCID)
The MCID will be calculated for each IMPACT module and subscale via an anchor-based approach, using a single global question designed to comprehensively assess how the patient feels regarding their facial injury.
Time frame: When the initial survey is completed (within 12 months of the injury).
Independent predictors of IMPACT scores
Independent variables that influence IMPACT scores for each module and subscale will be evaluated, including: demographics (age, sex, race, ethnicity), socioeconomic factors (social-vulnerability index, type of insurance), severity of trauma (Comprehensive facial injury \[CFI\] and Facial Injury Severity Score \[score\]), primary management (observation, closed treatment, and/or maxillomandibular fixation), multisystem trauma, and level of care (discharged from ED, admitted to floor / stepdown, or admitted to ICU).
Time frame: When the initial survey is completed (within 12 months of the injury).
Plan to share: Undecided
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