Facial InjuriesNCT06850857
Multi-Institutional IMPACT Validation
An observational study of Facial Injuries and Mandible Fracture, run by University of Tennessee at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Injuries, Mandible Fracture, Le Fort
- What is being tested?
- IMPACT-G Module, IMPACT-N Module and IMPACT-O Module
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 1. Diagnosis of maxillofacial trauma (fracture of any facial bone[s] and/or soft tissue injury) within 12 months of recruitment date.
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
University of California, Davis
Sacramento, California, 95817
University of California, San Francisco
San Francisco, California, 94110
About this study
Official title: Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)
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.
Read the detailed description
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.
- Conditions
- Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture, Nasal Fracture, Orbital Fractures
- Being tested
- IMPACT-G Module, IMPACT-N Module, IMPACT-O Module, IMPACT-J Module, 15D Control Survey
- Keywords
- Facial Trauma, Maxillofacial Trauma, Patient-Reported Outcomes, Quality of Life, IMPACT, Mandible Fracture, Midface Fracture, Orbital Fracture, Nasal Fracture
- Medical subject headings
- Facial Injuries, Mandibular Fractures, Orbital Fractures, Zygomatic Fractures, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPACT-G ModuleOther
Administration of the general IMPACT survey module.
IMPACT-N ModuleOther
Administration of the IMPACT-N survey module.
IMPACT-O ModuleOther
Administration of the IMPACT-O survey module.
IMPACT-J ModuleOther
Administration of the IMPACT-J survey module.
15D Control SurveyOther
Administration of the 15D QOL control survey.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: IMPACT-G Module; Other: IMPACT-J Module; Other: 15D Control Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The reliability of each module and subscale will be measured via Cronbach alpha's measurement of internal consistency,
Measured: 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.
Measured: 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.
Measured: 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.
Measured: When the initial survey is completed (within 12 months of the injury).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Facial InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis, University of Maryland, Vanderbilt University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850857
- Sponsor's protocol ID
- 24-09945-XP
- Status last verified
- Jun 2025
- First submitted
- 13 Feb 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29550964Ologunde 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.
PubMed 29650475
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Institutional Validation of the Integrated Modular Patient-Reported Outcome Assessment for Craniomaxillofacial Trauma (IMPACT)
- ClinicalTrials.gov ID
- NCT06850857
- Acronym / sponsor ID
- 24-09945-XP
- Conditions
- Facial Injuries, Mandible Fracture, Le Fort, Zygomaticomaxillary Complex Fracture, Nasal Fracture, Orbital Fractures
- Keywords
- Facial Trauma, Maxillofacial Trauma, Patient-Reported Outcomes, Quality of Life, IMPACT, Mandible Fracture, Midface Fracture, Orbital Fracture
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- University of California, San Francisco, University of California, Davis, University of Maryland, Vanderbilt University
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nasal Fractures (IMPACT-N) | – | Other: IMPACT-G Module, Other: IMPACT-N Module, Other: 15D Control SurveyThis 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. |
| Orbital Fractures (IMPACT-O) | – | Other: IMPACT-G Module, Other: IMPACT-O Module, Other: 15D Control SurveyThis 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. |
| Jaw Fractures (IMPACT-J) | – | Other: IMPACT-G Module, Other: IMPACT-J Module, Other: 15D Control SurveyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- 1. Diagnosis of maxillofacial trauma (fracture of any facial bone[s] and/or soft tissue injury) within 12 months of recruitment date.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPACT-G ModuleAdministration of the general IMPACT survey module. | Other | Jaw Fractures (IMPACT-J), Nasal Fractures (IMPACT-N), Orbital Fractures (IMPACT-O) |
| IMPACT-N ModuleAdministration of the IMPACT-N survey module. | Other | Nasal Fractures (IMPACT-N) |
| IMPACT-O ModuleAdministration of the IMPACT-O survey module. | Other | Orbital Fractures (IMPACT-O) |
| IMPACT-J ModuleAdministration of the IMPACT-J survey module. | Other | Jaw Fractures (IMPACT-J) |
| 15D Control SurveyAdministration of the 15D QOL control survey. | Other | Jaw Fractures (IMPACT-J), Nasal Fractures (IMPACT-N), Orbital Fractures (IMPACT-O) |
Primary outcome
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).
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.
4 secondary outcomes
Reliability: Covariance of each item in the IMPACT modules and subscales
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.
Time frame: At the completion of the second survey.
Sensitivity to Change: Change in IMPACT scores over the treatment course.
Time frame: Baseline (at recruitement, Day 0) and at 4 weeks.
Minimally Clinically Important Difference (MCID)
Time frame: When the initial survey is completed (within 12 months of the injury).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Background: PubMed 29550964Terwee 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.
- Background: PubMed 29650475Ologunde 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Injuries and Mandible Fracture, run by University of Tennessee at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06850857, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.