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Trial record 8 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Facial Injuries"

REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury (REDUCTION)

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ClinicalTrials.gov Identifier: NCT03314480
Recruitment Status : Not yet recruiting
First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Collaborators:
Isala Hospital
Nij Smellinghe Hosptial
Information provided by (Responsible Party):
Romke Rozema, University Medical Center Groningen

Brief Summary:
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.

Condition or disease Intervention/treatment
Maxillofacial Injuries Image Interpretation, Computer-Assisted Craniocerebral Trauma Emergency Medicine 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
Estimated Enrollment : 242 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Novel Clinical Decision Aid for the Diagnostic Management of Maxillofacial Trauma: the REDUCTION Trial - REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Maxillofacial fracture [ Time Frame: Within 1 day, from admission to discharge from the emergency department ]
    The presence of either a maxillofacial or mandibular fracture induced by the trauma and diagnosed using CT or orthopantomography in the emergency department.


Secondary Outcome Measures :
  1. Treatment outcome [ Time Frame: Within 2 weeks upon admission to the emegency department ]

    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


Other Outcome Measures:
  1. CT time [ Time Frame: Within 2 weeks from admission to the emergency department ]
    Time from admission to CT scanner

  2. Emergency department total time of admission [ Time Frame: Within 2 weeks from admission to the emergency department ]
    Total time the patient was of admitted at the emergency department



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals
Criteria

Inclusion Criteria:

  • consultation within 7 days of trauma

Exclusion Criteria:

  • history of maxillofacial surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314480


Contacts
Contact: Romke Rozema, BSc +31(0)50-3613827 r.rozema01@umcg.nl
Contact: Baucke van Minnen, MD DMD PhD +31(0)50-3613841 b.van.minnen@umcg.nl

Sponsors and Collaborators
University Medical Center Groningen
Isala Hospital
Nij Smellinghe Hosptial
Investigators
Principal Investigator: Fred KL Spijkervet, DMD PhD University of Groningen

Responsible Party: Romke Rozema, BSc, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03314480     History of Changes
Other Study ID Numbers: 201700304
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Romke Rozema, University Medical Center Groningen:
Multidetector Computed Tomography
Cone Beam Computed Tomography
Maxillofacial fractures
zygomaticomaxillary fractures

Additional relevant MeSH terms:
Wounds and Injuries
Emergencies
Craniocerebral Trauma
Maxillofacial Injuries
Disease Attributes
Pathologic Processes
Trauma, Nervous System
Nervous System Diseases
Facial Injuries