Maxillofacial InjuriesREDUCTIONNCT03314480
REDucing Unnecessary Computed Tomography Imaging for MaxillOfacial INjury
An observational study of Maxillofacial Injuries and Image Interpretation, Computer-Assisted, run by University Medical Center Groningen at 4 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Maxillofacial Injuries, Image Interpretation, Computer-Assisted, Craniocerebral Trauma
- What is being tested?
- Standardized physical examination
- How many people
- 1,126 participants
- Where
- 4 sitesNetherlands
- Study dates
- 1 May 2018to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals
Who may be able to join
- consultation within 7 days of trauma
Who cannot join
- history of maxillofacial surgery
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Nij Smellinghe ziekenhuis
Drachten, Provincie Friesland, 9202 NN
University Medical Center Groningen, University of Groningen
Groningen, 9713 GZ
Isala Diaconessenhuis
Meppel, Overijssel, 7943 KA
Isala ziekenhuis
Zwolle, Overijssel, 8000 GK
About this study
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
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.
Read the 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.
- Conditions
- Maxillofacial Injuries, Image Interpretation, Computer-Assisted, Craniocerebral Trauma, Emergency Medicine
- Being tested
- Standardized physical examination
- Keywords
- Multidetector Computed Tomography, Cone Beam Computed Tomography, Maxillofacial fractures, zygomaticomaxillary fractures
- Medical subject headings
- Maxillofacial Injuries, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized physical examinationDiagnostic test
Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.
| Study group | Role | What they receive |
|---|---|---|
| Midfacial fracture suspected patients | Patients who are suspected of maxillofacial fracture Receives: Diagnostic Test: Standardized physical examination | |
| Mandibular fracture suspected patients | Patients who are suspected of a mandibular fracture Receives: Diagnostic Test: Standardized physical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 day, from admission to discharge from the emergency department
Secondary outcomes (1)
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
Measured: Within 2 weeks upon admission to the emegency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start1 May 2018
- Primary completion30 Sep 2019
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Isala, Nij Smellinghe Hosptial
- Responsible party
- Principal investigator, Romke Rozema, University Medical Center Groningen
- Investigators
- Fred KL Spijkervet, DMD PhD, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314480
- Sponsor's protocol ID
- 201700304
- Acronym
- REDUCTION
- Status last verified
- May 2022
- First submitted
- 4 Oct 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35430710Rozema 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.
PubMed 35211773
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03314480
- Acronym / sponsor ID
- REDUCTION / 201700304
- Conditions
- Maxillofacial Injuries, Image Interpretation, Computer-Assisted, Craniocerebral Trauma, Emergency Medicine
- Keywords
- Multidetector Computed Tomography, Cone Beam Computed Tomography, Maxillofacial fractures, zygomaticomaxillary fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,126 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Isala, Nij Smellinghe Hosptial
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Midfacial fracture suspected patients | – | Diagnostic Test: Standardized physical examinationPatients who are suspected of maxillofacial fracture |
| Mandibular fracture suspected patients | – | Diagnostic Test: Standardized physical examinationPatients who are suspected of a mandibular fracture |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with a maxillofacial trauma admitted to the emergency department of the cooperating hospitals
Key inclusion criteria (1 listed)
- consultation within 7 days of trauma
Key exclusion criteria (1 listed)
- history of maxillofacial surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized physical examinationStandarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region. | Diagnostic test | Mandibular fracture suspected patients, Midfacial fracture suspected patients |
Primary outcome
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.
1 secondary outcome
Treatment outcome
Time frame: Within 2 weeks upon admission to the emegency department
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 35430710Rozema 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.
- Derived from this study: PubMed 35211773Rozema 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred KL Spijkervet, DMD PhD principal investigator
University of Groningen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Injuries and Image Interpretation, Computer-Assisted, run by University Medical Center Groningen at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillofacial fracture (time frame: Within 1 day, from admission to discharge from the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314480, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.