An interventional study of Standard diagnostic item list in Trauma, sponsored by Zaans Medisch Centrum. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-05.
Sponsored by Zaans Medisch Centrum · Not applicable, Interventional, and Diagnostic
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.
114 studies on the registry are indexed under Shoulder Injuries; 31 are open to participants now.
This study's planned enrollment of 280 is above the median of 55 across 65 interventional studies indexed under Shoulder Injuries.
Browse Shoulder Injuries studies →This is the only study on the registry with Zaans Medisch Centrum as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be examined according to a standardized physical examination item list
Other: Standard diagnostic item list
Patients will be examined according to a standardized physical examination item list
Other: Standard diagnostic item list
All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.
Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
Time frame: An average of 12 to 18 months
Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient
Time frame: An average of 12 to 18 months
Plan to share: Undecided
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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