NCT03314480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,126

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

October 4, 2017

Last Update Submit

May 20, 2022

Conditions

Maxillofacial InjuriesImage Interpretation, Computer-AssistedCraniocerebral TraumaEmergency Medicine

Keywords

Multidetector Computed TomographyCone Beam Computed TomographyMaxillofacial fractureszygomaticomaxillary fractures

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Treatment outcome

    Within 2 weeks upon admission to the emegency department

Other Outcomes (2)

  • CT time

    Within 2 weeks from admission to the emergency department

  • Emergency department total time of admission

    Within 2 weeks from admission to the emergency department

Study Arms (2)

Midfacial fracture suspected patients

Patients who are suspected of maxillofacial fracture

Diagnostic Test: Standardized physical examination

Mandibular fracture suspected patients

Patients who are suspected of a mandibular fracture

Diagnostic Test: Standardized physical examination

Interventions

Standardized physical examinationDIAGNOSTIC_TEST

Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.

Mandibular fracture suspected patientsMidfacial fracture suspected patients

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • consultation within 7 days of trauma

You may not qualify if:

  • history of maxillofacial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Isala Diaconessenhuis

Meppel, Overijssel, 7943 KA, Netherlands

Location

Isala ziekenhuis

Zwolle, Overijssel, 8000 GK, Netherlands

Location

Nij Smellinghe ziekenhuis

Drachten, Provincie Friesland, 9202 NN, Netherlands

Location

University Medical Center Groningen, University of Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 35430710DERIVED

  • 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.

    PMID: 35211773DERIVED

MeSH Terms

Conditions

Maxillofacial InjuriesCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Facial InjuriesTrauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Fred KL Spijkervet, DMD PhD

    University of Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 19, 2017

Study Start

May 1, 2018

Primary Completion

September 30, 2019

Study Completion

June 1, 2021

Last Updated

May 23, 2022

Record last verified: 2022-05

Locations

NL(4)