Trauma Clinical Trial
Official title:
Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
What combination of ≤ 6 clinical variables will give the highest specificity for indicating
significant shoulder injuries (fractures or dislocations) with a set sensitivity of ≥ 97%?
Although shoulder trauma is a common injury, there is no clinical decision rule to determine
the necessity for radiography for these traumas. With this trial the investigators aim to
develop such a rule to reduce the amount of radiographs without missing any significant
injuries.
The primary objective is to compose a set of clinical diagnostic criteria predictive of
shoulder fractures or dislocations that would reduce the amount of radiographs without
missing any significant injuries. A second objective is to determine if the clinical
decision rule is applicable for triage use.
The CASH (Clavicle-AC-Joint-Sub-capital-Humerus) trial is designed as a cross sectional
interobserver study. It will randomize between first examiner of the patient to determine
applicability for triage use and use a list of 19 criteria to determine a clinical decision
rule for significant shoulder injuries.
Method/intervention After admittance to the ED, all consecutive shoulder injury patients
will be assessed for eligibility in the study. After informed consent is given, the patient
will be randomized for first observer (ED physician or triage nurse) to be examined, which
means they will be assessed in duplo.
The patient will be examined by means of a score form, which contains 19 different
diagnostic criteria. The criteria are grouped: anamnesis, inspection, palpation and
pain/range of motion(ROM). After completing the list, patients will get a full set of
shoulder x-rays: shoulder AP- and axial-view, and clavicle AP and 30' cranio-caudal view.
The trial participation for the patient will be completed at this point and final diagnosis
and treatment are provided by the ED physician according to his/her own findings and
interpretation of the radiographs. For the study, the radiographs will be reassessed by one
consultant radiologist specialized in skeletal trauma.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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