Clinical trial NCT02857439: Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
Official title: Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Keywords: Trauma of the shoulder
Lead sponsor: Zaans Medisch Centrum
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged18-65 years
* Trauma \<48h

Exclusion Criteria:

* Any prior ipsilateral shoulder surgery.
* Any diseases of the bones potentially influencing fracturability (osteogenesis imperfecta, osteoporosis, achondroplasia, M. Kahler, chronic (\> 1yr) prednisone use \> 5mg)
* Any shoulder injury as part of a multi-trauma or high energy trauma (HET) with distractible injuries
* Any condition that will influence the perception of pain (e.g. alcohol intoxication, psychiatric problems, mental retardation)

Primary outcomes:
measure: Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.
timeFrame: An average of 12 to 18 months
Secondary outcomes:
measure: Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient
timeFrame: An average of 12 to 18 months
Other outcomes:
Locations:
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
state: Noord-Holland
Study officials:
name: Kim Rijsbergen, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Zaans Medisch Centrum
name: Robert Jan Derksen, MD
role: STUDY_DIRECTOR
References:
citation: Stiell IG, Greenberg GH, McKnight RD, Nair RC, McDowell I, Worthington JR. A study to develop clinical decision rules for the use of radiography in acute ankle injuries. Ann Emerg Med. 1992 Apr;21(4):384-90. doi: 10.1016/s0196-0644(05)82656-3.
citation: Bachmann LM, Kolb E, Koller MT, Steurer J, ter Riet G. Accuracy of Ottawa ankle rules to exclude fractures of the ankle and mid-foot: systematic review. BMJ. 2003 Feb 22;326(7386):417. doi: 10.1136/bmj.326.7386.417.
citation: Stiell I, Wells G, Laupacis A, Brison R, Verbeek R, Vandemheen K, Naylor CD. Multicentre trial to introduce the Ottawa ankle rules for use of radiography in acute ankle injuries. Multicentre Ankle Rule Study Group. BMJ. 1995 Sep 2;311(7005):594-7. doi: 10.1136/bmj.311.7005.594.