Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

Trauma Clinical Trial

— CASH  

Official title:

Creating a Diagnostic Decision Rule for Shoulder Injury: CASH-trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857439
• Other study ID #: CASH Zaansmc
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 2, 2016
• Start date: July 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: Zaans Medisch Centrum
• Contact: Robert Jan Derksen, MD
• Email: Derksen.R[@]zaansmc.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Trauma

Intervention

Other:
• Standard diagnostic item list
All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.

Locations

Country	Name	City	State
Netherlands	Zaans Medisch Centrum	Zaandam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Zaans Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy (sensitivity and specificity) of the clinical variables assessed with the score form.		An average of 12 to 18 months	No
Secondary	Interobserver agreement for each clinical variable between both observers determined with the Cohen's kappa coefficient		An average of 12 to 18 months	No