REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

Study Overview
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Brief Summary
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The aim is to prospectively assess the association between clinical parameters and the presence of maxillofacial fractures in trauma patients admitted to the emergency department. Our hypothesis is that a clinical decision aid of critical parameters reduces unnecessary produced CT scans in maxillofacial trauma patients.

Detailed Description
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The REDUCTION trial is a prospective multicentre cohort study conducted at the level I emergency departments of the University Medical Center Groningen, Isala hospital (Zwolle, The Netherlands) and the level II trauma center Nij Smellinghe hospital (Drachten, The Netherlands). The increased availability of Computed Tomography (CT) in the emergency department is leading to an overuse for patients with suspected maxillofacial injury. The use of a clinical decision aid could lead to more expedient use of diagnostic imaging within this population of patients. Therefore, all maxillofacial trauma patients admitted to the emergency department are included in this trial if the consultation is within 7 days after trauma. Both maxillofacial trauma patients admitted to CT scan and patients without a radiological confirmed diagnosis are included. The research protocol was approved by the institutional review board of the University Medical Center Groningen (Groningen, The Netherlands). Informed consent was waived as patients are treated according to the standards of care. Upon admission, each patient with maxillofacial injury will be allocated as a midfacial or mandibular trauma. During physical examination, either by the emergency physician or surgical resident, a pre-defined selection of clinical parameters will be assessed focussing on the assessment of potential presence of fractures in the maxillofacial region. The standardization of this examination will be ensured using a pocket map and easy accessible online instructional video's. The clinical parameters, fracture likelihood and physical examination findings will be structurally reported in electronic health record software using a smart tool dedicated for maxillofacial injury. Data regarding patient demographics, mechanism of injury, concomitant injury, diagnostic outcome and radiation dose parameters will be derived from the medical records.

Official Title
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A Novel Clinical Decision Aid for the Diagnostic Management of Maxillofacial Trauma: the REDUCTION Trial - REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury

Conditions
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Maxillofacial Injuries, Image Interpretation, Computer-Assisted, Craniocerebral Trauma, Emergency Medicine

Intervention / Treatment
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* Diagnostic Test: Standardized physical examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consultation within 7 days of trauma Exclusion Criteria: history of maxillofacial surgery

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Midfacial fracture suspected patients<br>Patients who are suspected of maxillofacial fracture | Diagnostic Test: Standardized physical examination<br>* Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.<br>|
| Mandibular fracture suspected patients<br>Patients who are suspected of a mandibular fracture | Diagnostic Test: Standardized physical examination<br>* Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxillofacial fracture | The presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department. | Within 1 day, from admission to discharge from the emergency department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment outcome | The outcome of the treatment as determined by the Oral and Maxillofacial (OMF) surgeon or emergency physician classified as; Admission and direct surgical treatment Admission following elective surgery Discharge following elective surgery Discharge, expectative treatment and follow-up after seven days Discharge, conservative treatment and follow-up after seven days Discharge, conservative treatment, no follow-up | Within 2 weeks upon admission to the emegency department | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multidetector Computed Tomography, Cone Beam Computed Tomography, Maxillofacial fractures, zygomaticomaxillary fractures