An observational study in Maxillofacial Injuries, Image Interpretation, Computer-Assisted and Craniocerebral Trauma, sponsored by University Medical Center Groningen. Completed at 4 sites in Netherlands. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by University Medical Center Groningen · Observational
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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.
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.
22 studies on the registry are indexed under Maxillofacial Injuries; 7 are open to participants now.
This study's enrollment of 1,126 is above the median of 55 across 10 observational studies indexed under Maxillofacial Injuries.
Browse Maxillofacial Injuries studies →University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 175 are open to participants now.
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All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals
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Exclusion Criteria:
Patients who are suspected of maxillofacial fracture
Diagnostic Test: Standardized physical examination
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.
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.
Time frame: Within 1 day, from admission to discharge from the emergency department
Treatment outcome
The outcome of the treatment as determined by the Oral and Maxillofacial (OMF) surgeon or emergency physician classified as; 1. Admission and direct surgical treatment 2. Admission following elective surgery 3. Discharge following elective surgery 4. Discharge, expectative treatment and follow-up after seven days 5. Discharge, conservative treatment and follow-up after seven days 6. Discharge, conservative treatment, no follow-up
Time frame: Within 2 weeks upon admission to the emegency department
CT time
Time from admission to CT scanner
Time frame: 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
Time frame: Within 2 weeks from admission to the emergency department
Ran from May 2018 to primary completion in Sep 2019, 16 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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