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VALIDATION OF CLINICAL DECISION AIDS FOR MIDFACIAL AND MANDIBULAR INJURY, THE REDUCTION V TRIAL, A prospective multicentre cohort trial.

VALIDATION OF CLINICAL DECISION AIDS FOR MIDFACIAL AND MANDIBULAR INJURY, THE REDUCTION V TRIAL, A prospective multicentre cohort trial. - REDUCTION-V

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56277
Enrollment
1300
Registered
2023-10-31
Start date
2024-01-10
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillofaciale fracturen facial injury Maxillofacial injury

Interventions

Each patient with a midfacial and/or mandibular injury will receive a standardised physical examination based on the REDUCTION I and II clinical decision aids. The midfacial and/or mandibular clinic

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with midfacial and/or mandibular injury with a possibility of midface or mandible fracture are eligible for inclusion if the following conditions are met -Visible injuries to the face or in the oral cavity. -A trauma mechanism suspected of causing facial fractures, e.g., punch to the face, fall to the chin, traffic accident, etc. -An anamnesis that clearly indicates a facial trauma. -Patients aged >= 18 years

Exclusion criteria

Exclusion criteria: Patients with non-energetic maxillofacial injury i.e. cutting wounds or spontaneous epistaxis Patients who are not admitted for the first time with maxillofacial injury within the inclusion period. Patients whose initial assessment is performed in another hospital. Patients who have declined access to medical records and are registered in the objection register . Patients who have had reconstructive surgery in the now affected maxillofacial region.

Design outcomes

Primary

MeasureTime frame
The primary outcomes are 1) the sensitivity, specificity and negative predictive value of the REDUCTION I decision aids for diagnosing and excluding the presence of a midfacial or mandibular fracture compared to the CT and CBCT and 2) the sensitivity, specificity and negative predictive value of the REDUCTION II decision aids for excluding the presence of a midfacial or mandibular fracture requiring active treatment compared to the standard care.

Secondary

MeasureTime frame
Rating the probability of having a maxillofacial fracture before and after the physical examination (ranging from 0 - 10), where 0 indicates a low probability of having a maxillofacial fracture and 10 indicates a high probability of having a maxillofacial fracture. As an additional option, 11 is added to indicate that the maxillofacial fracture is known to the attending physician prior to assessment. Severity of maxillofacial injury based on the Facial Injury Severity Score (FISS). Each diagnosed maxillofacial fracture or laceration longer than 10 cm is given a score from 1 to 6 on the FISS, and the sum of all scored fractures or lacerations gives an indication of the overall severity of the acquired maxillofacial injury. The overall injury severity, based on the Abbreviated Injury Scale (AIS) and the Injury Severity Score (ISS). The AIS is a 6-point scale, where 1 represents the least severe injury and 6 the most severe, where the injury results in death. The AIS is used to calculate the ISS as a measure of overall injury severity. Presence of dental injury Presence of skull fractures

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 2, 2026