REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury (REDUCTION)

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

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.

Study Overview

• Status: Completed
• Conditions: Craniocerebral Trauma; Emergency Medicine; Maxillofacial Injuries; Image Interpretation, Computer-Assisted
• Intervention / Treatment: Diagnostic test: Standardized physical examination

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1126

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen, University of Groningen
  • Friesland
    • Drachten, Friesland, Netherlands, 9202 NN
      • Nij Smellinghe Ziekenhuis
  • Overijssel
    • Meppel, Overijssel, Netherlands, 7943 KA
      • Isala Diaconessenhuis
    • Zwolle, Overijssel, Netherlands, 8000 GK
      • Isala Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals

Description

Inclusion Criteria:

• consultation within 7 days of trauma

Exclusion Criteria:

• history of maxillofacial surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Midfacial fracture suspected patients; Patients who are suspected of maxillofacial fracture	Diagnostic test: Standardized physical examination; Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.
Mandibular fracture suspected patients; Patients who are suspected of a mandibular fracture	Diagnostic test: Standardized physical examination; Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT time	Time from admission to CT scanner	Within 2 weeks from admission to the emergency department
Emergency department total time of admission	Total time the patient was of admitted at the emergency department	Within 2 weeks from admission to the emergency department

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Nij Smellinghe Hosptial; Isala
• Investigators: Principal Investigator: Fred KL Spijkervet, DMD PhD, University of Groningen

Publications and helpful links

General Publications

• Rozema R, Moumni ME, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid for patients with suspected midfacial and mandibular fractures (the REDUCTION-I study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Oct;48(5):4243-4254. doi: 10.1007/s00068-022-01968-1. Epub 2022 Apr 16.
• Rozema R, El Moumni M, de Vries GT, Spijkervet FKL, Verbeek R, Kleinbergen JYJ, Bens BWJ, Doff MHJ, van Minnen B; REDUCTION study group. A clinical decision aid to discern patients without and with midfacial and mandibular fractures that require treatment (the REDUCTION-II study): a prospective multicentre cohort study. Eur J Trauma Emerg Surg. 2022 Aug;48(4):2547-2558. doi: 10.1007/s00068-022-01892-4. Epub 2022 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Multidetector Computed Tomography; Cone Beam Computed Tomography; Maxillofacial fractures; zygomaticomaxillary fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Trauma, Nervous System; Facial Injuries; Emergencies; Wounds and Injuries; Craniocerebral Trauma; Maxillofacial Injuries
• Other Study ID Numbers: 201700304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No